Infection, Human Immunodeficiency Virus, HIV Infections
Conditions
Keywords
safety, treatment naïve, HIV 1, dolutegravir plus lamivudine, non inferiority, tolerability, dolutegravir plus tenofovir/emtricitabine, efficacy
Brief summary
This study will compare safety, efficacy, and tolerability of a two drug regimen of dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two nucleoside reverse transcriptase inhibitors (Tenofovir \[TDF\]/Emtricitabine \[FTC\] fixed dose combination \[FDC\]) administered once daily in human immunodeficiency virus (HIV) 1 infected adult participants that have not previously received antiretroviral therapy. The study is designed to demonstrate the non-inferior antiviral activity of DTG plus 3TC regimen to that of DTG plus TDF/FTC FDC and will characterise the long term antiviral activity, tolerability and safety of DTG plus 3TC through Week 148. Approximately, 700 participants will be randomised 1:1 to receive DTG + 3TC or DTG + TDF/FTC FDC. Participants will be stratified by screening HIV 1 ribonucleotide nucleic acid (RNA) levels and by screening CD4+ (cluster of differentiation 4) cell count.
Interventions
DTG is available as 50 mg white, round, biconvex, film coated tablet debossed on one side with 'SV 572' and on the other side with '50'. The tablets are packaged into high density polyethylene (HDPE) bottles with induction seals and child resistant closures. Each 45 ml bottle contains 30 tablets and a desiccant. DTG 50 mg tablet will be orally administered once daily with or without food upto 148 weeks.
DRUGLamivudine (3TC)
Lamivudine is available as swedish orange, 'AA' sized elongated double blind HPMC capsules containing 300 mg lamivudine to visually match overencapsulated TDF/FTC FDC tablet. The capsules are packaged into HDPE bottles with induction seals and child resistant closures. Each 150 mL bottle contains 30 capsules and a desiccant. Overencapsulated 3TC 300 mg tablet will be orally administered once daily with or without food upto 96 weeks. From Week 96 to Week 148, lamivudine will be dispensed as 300 mg white, diamond shaped, scored, film coated tablets debossed with 'GX CJ7' on both sides, packed in over labelled HDPE bottles with child-resistant closures each containing 30 tablets.
Tenofovir disoproxil fumarate and Emtricitabine are available as swedish orange, 'AA' sized elongated double blind HPMC capsules containing 300 mg TDF and 200 mg FTC to visually match overencapsulated 3TC tablet. The capsules are packaged into HDPE bottles with induction seals and child resistant closures. Each 150 mL bottle contains 30 capsules and a desiccant. Overencapsulated tenofovir disoproxil fumarate/emtricitabine tablet will be orally administered once daily with or without food upto 96 weeks. From Week 96 to Week 148, tenofovir disoproxil fumarate/emtricitabine will be dispensed as 300/200 mg white, blue, capsule shaped, film coated tablets debossed with 'GILEAD' on one side and '701' on another side, packed in overlabelled HDPE bottles with polypropylene childresistant closures each containing 30 tablets and a desiccant.
Sponsors
PPD Development, LP
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be an HIV 1 infected adult \>=18 years of age (or older, if required by local regulations) at the time of signing the informed consent * An eligible female participant should not be pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at Screening and negative urine test at Baseline), not lactating, and at least one of the following conditions applies * Non reproductive premenopausal women are those that have undergone documented tubal ligation or documented hysteroscopic tubal occlusion procedure with follow up confirmation of bilateral tubal occlusion or documented bilateral oophorectomy or hysterectomy * Non reproductive premenopausal women are those with 12 months of spontaneous amenorrhea and \>=45 years of age * Women with reproductive potential agree to follow one of the protocol-defined methods for avoiding pregnancy * Should have screening plasma HIV 1 RNA levels of 1000 c/mL to \<=100,000 c/mL. If an independent review of accumulated data from other clinical trials investigating the DTG plus 3TC dual regimen is supportive of the DTG plus 3TC treatment regimen, enrolment will be opened to participants with Screening plasma HIV 1 RNA of 1000 c/mL to \<=500,000 c/mL * Participants should be antiretroviral naïve (defined as \<=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection). Participants who received HIV post exposure prophylaxis (PEP) or pre exposure prophylaxis (PrEP) in the past are allowed as long as the last PEP/PrEP dose was \>1 year from HIV diagnosis or there is documented HIV seronegativity between the last prophylactic dose and the date of HIV diagnosis * Participant or the participants legal representative capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and the protocol * Participants enrolled in France: a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category
Exclusion criteria
* Women who are breastfeeding or plan to become pregnant or breastfeed during the study * Any evidence of an active centers for disease control and prevention (CDC) Stage 3 disease (CDC, 2014), except cutaneous Kaposi's sarcoma not requiring systemic therapy and historical or current CD4 cell counts less than 200 cells/mm\^3 * Participants with severe hepatic impairment (Class C) as determined by Child Pugh classification * Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones * Evidence of hepatitis B virus (HBV) infection or HBV surface antibody (anti-HBs or HBsAb) based on: Participants positive for HBV surface antigen (HBsAg) at screening will be excluded Participants negative for HBV core antibody (anti HBs) but positive for anti HBc (negative HBsAg status) and positive for HBV deoxyribose nucleic acid (DNA) will be excluded; however, participants positive for anti HBc (negative HBsAg status) and positive for anti HBs (past and/or current evidence) are immune to HBV and will not be excluded * Anticipated need for any hepatitis B virus (HCV) therapy during the first 48 weeks of the study and for HCV therapy based on interferon or any drugs that have a potential for adverse drug:drug interactions with study treatment throughout the entire study period * Untreated syphilis infection positive RPR at Screening without clear documentation of treatment. Participants who are at least 14 days post completed treatment are eligible * History or presence of allergy or intolerance to the study drugs or their components or drugs of their class * Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia; other localised malignancies require agreement between the investigator and the Study Medical Monitor for inclusion of the participant * Participants who in the Investigator's judgment, poses a significant suicidality risk. Recent history of suicidal behaviour and/or suicidal ideation may be considered as evidence of serious suicide risk * Treatment with an HIV 1 immunotherapeutic vaccine within 90 days of Screening * Treatment with any of the following agents within 28 days of Screening: * Radiation therapy, * Cytotoxic chemotherapeutic agents, * Any systemic immune suppressant * Treatment with any agent, except recognised ART as allowed above, with documented activity against HIV 1 in vitro within 28 days of first dose of study treatment * Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of study treatment * Participants enrolled in France: the participant has participated in any study using an investigational drug during the previous 60 days or 5 half lives, or twice the duration of the biological effect of the experimental drug or vaccine, whichever is longer, prior to screening for the study or the participant will participate simultaneously in another clinical study * Any evidence of pre existing viral resistance based on the presence of any major resistance associated mutation in the Screening result or, if known, in any historical resistance test result * Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening period to verify a result * Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the participants participation in the study of an investigational compound * Alanine aminotransferase (ALT) \>=5 times the upper limit of normal (ULN) or ALT \>=3xULN and bilirubin \>=1.5xULN (with \>35% direct bilirubin) * Creatinine clearance of \<50 mL/min per 1.73 m\^2 via the chronic kidney disease epidemiology collaboration (CKD EPI) method
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48 | Week 48 | Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights. Intent-To-Treat Exposed (ITT-E) Population was used which comprised of all randomized participants who received at least one dose of study treatment. Percentage values are rounded to the nearest whole digit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96 | Week 96 | Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel weights. Percentage values are rounded to the nearest whole digit. |
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144 | Week 144 | Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded to the nearest whole digit. |
| Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144 | Up to Week 144 | Time of viral suppression is defined as the first viral load value \<50 c/mL. Nonparametric Kaplan-Meier method was performed. Participants who withdrew for any reason without being suppressed were censored at date of withdrawal. Participants who have not been withdrawn and have not had viral suppression at time of the analysis were censored at last viral load date. Confidence Interval (CI) was estimated using the Brookmeyer-Crowley method. |
| CD4+ Cell Counts at Weeks 24 and 48 | Weeks 24 and 48 | CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. |
| CD4+ Cell Counts at Week 96 | Week 96 | CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. |
| CD4+ Cell Counts at Week 144 | Week 144 | CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. |
| Changes From Baseline in CD4+ Cell Counts at Week 24 and 48 | Baseline (Day 1) and Weeks 24, 48 | CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. |
| Changes From Baseline in CD4+ Cell Counts at Week 96 | Baseline (Day 1) and Week 96 | CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. |
| Changes From Baseline in CD4+ Cell Counts at Week 144 | Baseline (Day 1) and Week 144 | CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. |
| Number of Participants With HIV-1 Disease Progression up to Week 144 | Up to Week 144 | HIV-associated conditions were recorded during the study and was assessed according to the 2014 Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. Disease progressions summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrolment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrolment to Death. |
| Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144 | Up to Week 144 | Number of participants, who met confirmed virologic withdrawal (CVW) criteria, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI) and/or Nucleoside reverse transcriptase inhibitor (NRTI) was summarized. The Viral Genotypic Population comprised of all participants in the ITT-E population who have available on-treatment genotypic resistance data. |
| Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | Up to Week 144 | Number of participants, who meet CVW criteria, with treatment emergent phenotypic resistance to INSTI and/or NRTI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The Viral Phenotypic Population comprised of all participants in the ITT-E population who have available on-treatment phenotypic resistance data. |
| Number of Participants Who Discontinue Treatment Due to AEs Over Week 144 | Up to Week 144 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to AEs have been reported. |
| Number of Participants With Any AE and SAE up to Week 148 | Up to Week 148 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or protocol defined event associated with liver injury and impaired liver function were categorized as SAE. Safety Population was used which comprised of all participants who received at least one dose of study treatment. |
| Number of Participants With AEs by Maximum Severity Grades up to Week 144 | Up to Week 144 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. |
| Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 144 | Up to Week 144 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5. (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with drug related AEs and drug related AEs by by maximum grade have been presented. |
| Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Up to Week 144 | Blood samples were collected up to Week 144 for assessment of hemoglobin, leukocytes, neutrophils and platelets. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the listed hematology parameters have been presented. |
| Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Up to Week 144 | Blood samples were collected up to Week 144 for assessment of Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate aminotransferase (AST), Bilirubin, Carbon dioxide (CO2), Cholesterol, Creatine kinase (CK), Creatinine, Direct Bilirubin, Glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), Hypercalcemia, Hyperglycemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycemia, Hypokalemia, Hyponatremia, Low density lipid (LDL) Cholesterol, Lactate Dehydrogenase, Lipase, Phosphate, and Triglycerides. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent chemistry toxicities in any of the chemistry parameters have been presented |
| Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96 | Up to Week 24, Week 48 and Week 96 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. . Number of participants who discontinued treatment due to AEs have been reported. |
| Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48 | Baseline (Day 1) and at Weeks 24, 48 | Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Serum Cystatin C and Serum Retinol Binding Protein (RBP). Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. |
| Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96 | Baseline (Day 1) and at Week 96 | Blood samples were collected to perform evaluation of renal inflammation biomarkers which included Serum Cystatin C . Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. |
| Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144 | Baseline (Day 1) and at Week 144 | Blood samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error is presented. |
| Change From Baseline in Renal Biomarker-Serum RBP at Week 96 | Baseline (Day 1) and at Week 96 | Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. |
| Change From Baseline in Renal Biomarker-Serum RBP at Week 144 | Baseline (Day 1) and at Week 144 | Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. |
| Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48 | Baseline (Day 1) and at Weeks 24, 48 | Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI (GFR-cystatin C adjusted)and Serum or Plasma GFR from creatinine adjusted using CKD-EPI. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. |
| Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96 | Baseline (Day 1) and at Week 96 | Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. |
| Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96 | Baseline (Day 1) and at Week 96 | Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. |
| Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144 | Baseline (Day 1) and at Week 144 | Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. |
| Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48 | Baseline (Day 1) and at Weeks 24, 48 | Blood and/or urine were collected to perform evaluation of renal inflammation biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. |
| Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96 | Baseline (Day 1) and at Week 96 | Blood and/or urine were collected to perform evaluation of renal inflammation biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. |
| Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144 | Baseline (Day 1) and at Week 144 | Blood and/or urine were collected to perform evaluation of renal inflammation biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. |
| Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Baseline (Day 1) and at Weeks 24, 48 | Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Statistical analysis of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. Estimated ratio of geometric means (each visit over Baseline) and 95% confidence interval (CI) have been presented. |
| Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96 | Baseline (Day 1) and Week 96 | Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Statistical analysis of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. Estimated ratio of geometric means (each visit over Baseline) and 95% confidence interval (CI) have been presented. |
| Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144 | Baseline (Day 1) and Week 144 | Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Statistical analysis of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. Estimated ratio of geometric means (each visit over Baseline) and 95% confidence interval (CI) have been presented. |
| Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144 | Baseline (Day 1) and at Week 144 | Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. |
| Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 | Baseline (Day 1) and at Weeks 24, 48 | Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. |
| Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96 | Baseline (Day 1) and at Week 96 | Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. |
| Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144 | Baseline (Day 1) and at Week 144 | Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. |
| Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48 | Baseline (Day 1) and at Weeks 24, 48 | Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. |
| Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96 | Baseline (Day 1) and at Week 96 | Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. |
| Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144 | Baseline (Day 1) and at Week 144 | Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. |
| Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | Baseline (Day 1) and at Weeks 24, 48 | Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value is defined as the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by (\[post-dose visit value minus Baseline value\] divided by Baseline value). |
| Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96 | Baseline (Day 1) and at Week 96 | Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. |
| Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48 | Baseline (Day 1) and at Weeks 24, 48 | Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by (\[post-dose visit value minus Baseline value\] divided by Baseline value). |
| Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144 | Baseline (Day 1) and at Week 144 | Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. |
| Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48 | Weeks 24 and Week 48 | Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Weeks 24 and 48 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 48 or those who had Baseline lipids-lowering agents are not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded to the nearest whole digit. |
| Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96 | Week 96 | Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 96 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 96 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded to the nearest whole digit. |
| Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144 | Week 144 | Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 144 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 144 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded to the nearest whole digit. |
| Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Week 24 | Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (\<35, 35 to \<50, \>=50 years); gender (males and females), Baseline CD4+ cell count (\<=200, \>200), Baseline HIV-1 RNA (\<=100000, \>100000) and Race (White, African American/African H., Asian, Other). Percentage values are rounded to the nearest whole digit. |
| Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Week 48 | Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (\<35, 35 to \<50, \>=50 years); gender (males and females), Baseline CD4+ cell count (\<=200, \>200), Baseline HIV-1 RNA (\<=100000, \>100000) and Race (White, African American/African H., Asian, Other). Percentage values are rounded to the nearest whole digit. |
| Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Week 96 | Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (\<35, 35 to \<50, \>=50 years); gender (males and females), Baseline CD4+ cell count (\<=200 cells/mm\^3, \>200 cells/mm\^3), Baseline HIV-1 RNA (\<=100000, \>100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded to the nearest whole digit. |
| Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Week 144 | Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (\<35, 35 to \<50, \>=50 years); gender (males and females), Baseline CD4+ cell count (\<=200 cells/mm\^3, \>200 cells/mm\^3), Baseline HIV-1 RNA (\<=100000, \>100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded to the nearest whole digit. |
| Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Baseline (Day 1) and Week 24 | CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age, Gender, and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. |
| Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Baseline (Day 1) and Week 48 | CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from Analysis of Covariance (ANCOVA) model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. |
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24 | Week 24 | Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel weights. Percentage values are rounded to the nearest whole digit. |
| Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Baseline (Day 1) and Week 144 | CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. |
| Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48 | Baseline (Day 1) and Weeks 4, 24, 48 | EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment (Day 1) and change from Baseline=post-dose value minus Baseline value. |
| Change From Baseline in EQ-5D-5L Utility Score at Week 96 | Baseline (Day 1) and Week 96 | EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment (Day 1) and change from Baseline=post-dose value minus Baseline value. |
| Change From Baseline in EQ-5D-5L Utility Score at Week 144 | Baseline (Day 1) and Week 144 | EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment (Day 1) and change from Baseline=post-dose value minus Baseline value. |
| Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24 48 | Baseline (Day 1) and Weeks 4, 24, 48 | EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. |
| Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96 | Baseline (Day 1) and Week 96 | EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. |
| Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144 | Baseline (Day 1) and Week 144 | EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. |
| Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Baseline (Day 1) and Week 96 | CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. |
Countries
Argentina, Australia, Belgium, Canada, France, Germany, Italy, Mexico, Netherlands, Portugal, Romania, Russia, South Africa, South Korea, Spain, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
This study is a randomized, double-blind, parallel-group, non-inferiority study. The study consisted of double blind, open label, and continuation phase.
Pre-assignment details
Total of 719 participants were enrolled and randomized. Five participants were randomized but not treated. A total of 714 participants received at least one dose of study treatment, following randomization creating the intent to treat exposed (ITT-E) population.
Participants by arm
| Arm | Count |
|---|---|
| DTG + 3TC-Double Blind Phase Participants received a two-drug regimen of dolutegravir plus lamivudine (DTG + 3TC) once daily for 96 weeks in the double blind phase | 356 |
| DTG + TDF/FTC-Double Blind Phase Participants received a three-drug regimen of dolutegravir plus tenofovir/emtricitabine (DTG + TDF/FTC) fixed dose combination (FDC) once daily for 96 weeks in the double blind phase. | 358 |
| Total | 714 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Continuation Phase(Week 148 to Week 280) | Adverse Event | 0 | 0 | 0 | 0 | 1 |
| Continuation Phase(Week 148 to Week 280) | Lost to Follow-up | 0 | 0 | 0 | 0 | 10 |
| Continuation Phase(Week 148 to Week 280) | Physician Decision | 0 | 0 | 0 | 0 | 2 |
| Continuation Phase(Week 148 to Week 280) | Protocol Deviation | 0 | 0 | 0 | 0 | 1 |
| Continuation Phase(Week 148 to Week 280) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 7 |
| Double-blind (Day 1 to Week 96) | Adverse Event | 10 | 7 | 0 | 0 | 0 |
| Double-blind (Day 1 to Week 96) | Lack of Efficacy | 4 | 2 | 0 | 0 | 0 |
| Double-blind (Day 1 to Week 96) | Lost to Follow-up | 13 | 7 | 0 | 0 | 0 |
| Double-blind (Day 1 to Week 96) | Physician Decision | 9 | 4 | 0 | 0 | 0 |
| Double-blind (Day 1 to Week 96) | Protocol Deviation | 6 | 6 | 0 | 0 | 0 |
| Double-blind (Day 1 to Week 96) | Protocol Withdrawal Criterion Met | 2 | 6 | 0 | 0 | 0 |
| Double-blind (Day 1 to Week 96) | Randomized but not treated | 3 | 2 | 0 | 0 | 0 |
| Double-blind (Day 1 to Week 96) | Withdrawal by Subject | 11 | 6 | 0 | 0 | 0 |
| Open-label Phase (Week 96 to Week 148) | Adverse Event | 0 | 0 | 3 | 6 | 0 |
| Open-label Phase (Week 96 to Week 148) | Lack of Efficacy | 0 | 0 | 1 | 2 | 0 |
| Open-label Phase (Week 96 to Week 148) | Lost to Follow-up | 0 | 0 | 7 | 6 | 0 |
| Open-label Phase (Week 96 to Week 148) | Physician Decision | 0 | 0 | 1 | 4 | 0 |
| Open-label Phase (Week 96 to Week 148) | Protocol Deviation | 0 | 0 | 0 | 1 | 0 |
| Open-label Phase (Week 96 to Week 148) | Protocol-Specified Withdrawal Criterion Met | 0 | 0 | 2 | 1 | 0 |
| Open-label Phase (Week 96 to Week 148) | Withdrawal by Subject | 0 | 0 | 6 | 5 | 0 |
Baseline characteristics
| Characteristic | DTG + TDF/FTC-Double Blind Phase | Total | DTG + 3TC-Double Blind Phase |
|---|---|---|---|
| Age, Continuous | 35.0 Years STANDARD_DEVIATION 10.72 | 34.5 Years STANDARD_DEVIATION 10.31 | 34.0 Years STANDARD_DEVIATION 9.88 |
| Race/Ethnicity, Customized Race American (Am) Indian or Alaska (Al.) native | 28 Participants | 59 Participants | 31 Participants |
| Race/Ethnicity, Customized Race Asian-Central/South Asian heritage (H.) | 4 Participants | 4 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian - East Asian H. | 36 Participants | 69 Participants | 33 Participants |
| Race/Ethnicity, Customized Race Asian - South East Asian H. | 2 Participants | 6 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Black or African Am | 36 Participants | 75 Participants | 39 Participants |
| Race/Ethnicity, Customized Race Multiple | 5 Participants | 8 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race White - White/Caucasian/European H. | 242 Participants | 481 Participants | 239 Participants |
| Race/Ethnicity, Customized Race White (Wt)-Arabic/North African H. | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Female | 52 Participants | 111 Participants | 59 Participants |
| Sex: Female, Male Male | 306 Participants | 603 Participants | 297 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 356 | 0 / 358 | 0 / 233 |
| other Total, other adverse events | 272 / 356 | 268 / 358 | 46 / 233 |
| serious Total, serious adverse events | 37 / 356 | 38 / 358 | 5 / 233 |
Outcome results
Primary
Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48
Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights. Intent-To-Treat Exposed (ITT-E) Population was used which comprised of all randomized participants who received at least one dose of study treatment. Percentage values are rounded to the nearest whole digit.
Time frame: Week 48
Population: ITT-E Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTG + 3TC-Double Blind Phase | Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48 | 90 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48 | 93 Percentage of participants |
95% CI: [-6.7, 1.5]
Secondary
CD4+ Cell Counts at Week 144
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry.
Time frame: Week 144
Population: ITT-E Population. Only those participants available at the specified time points were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | CD4+ Cell Counts at Week 144 | 767.8 Cells per cubic millimeter (cells/mm^3) | Standard Deviation 274 |
| DTG + TDF/FTC-Double Blind Phase | CD4+ Cell Counts at Week 144 | 758.2 Cells per cubic millimeter (cells/mm^3) | Standard Deviation 285.35 |
Secondary
CD4+ Cell Counts at Week 96
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry.
Time frame: Week 96
Population: ITT-E Population. Only those participants available at the specified time points were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | CD4+ Cell Counts at Week 96 | 732.8 Cells per cubic millimeter (cells/mm^3) | Standard Deviation 298.05 |
| DTG + TDF/FTC-Double Blind Phase | CD4+ Cell Counts at Week 96 | 711.5 Cells per cubic millimeter (cells/mm^3) | Standard Deviation 284.15 |
Secondary
CD4+ Cell Counts at Weeks 24 and 48
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry.
Time frame: Weeks 24 and 48
Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | CD4+ Cell Counts at Weeks 24 and 48 | Week 24, n=340,341 | 655.3 Cells per cubic millimeter (cells/mm^3) | Standard Deviation 288.32 |
| DTG + 3TC-Double Blind Phase | CD4+ Cell Counts at Weeks 24 and 48 | Week 48, n=324,334 | 687.7 Cells per cubic millimeter (cells/mm^3) | Standard Deviation 275.47 |
| DTG + TDF/FTC-Double Blind Phase | CD4+ Cell Counts at Weeks 24 and 48 | Week 24, n=340,341 | 632.8 Cells per cubic millimeter (cells/mm^3) | Standard Deviation 262.61 |
| DTG + TDF/FTC-Double Blind Phase | CD4+ Cell Counts at Weeks 24 and 48 | Week 48, n=324,334 | 675.3 Cells per cubic millimeter (cells/mm^3) | Standard Deviation 274.46 |
Secondary
Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144
Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor.
Time frame: Baseline (Day 1) and at Week 144
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144 | -2.0 Nanomoles per Liter (nmol/L) | Standard Error 1.16 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144 | 2.9 Nanomoles per Liter (nmol/L) | Standard Error 1.28 |
p-value: 0.00495% CI: [-8.3, -1.6]Mixed Model Repeated Measures
Secondary
Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96
Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor.
Time frame: Baseline (Day 1) and at Week 96
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96 | -2.2 Nanomoles per Liter (nmol/L) | Standard Error 1.05 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96 | 0.7 Nanomoles per Liter (nmol/L) | Standard Error 1.04 |
p-value: 0.04895% CI: [-5.8, 0]Mixed Model Repeated Measures
Secondary
Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48
Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor.
Time frame: Baseline (Day 1) and at Weeks 24, 48
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48 | Serum Vitamin D, Week 24, n=337, 337 | 5.9 Nanomoles per Liter (nmol/L) | Standard Error 1.15 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48 | Serum Vitamin D, Week 48, n=322, 333 | -3.1 Nanomoles per Liter (nmol/L) | Standard Error 0.89 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48 | Serum Vitamin D, Week 24, n=337, 337 | 12.4 Nanomoles per Liter (nmol/L) | Standard Error 1.33 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48 | Serum Vitamin D, Week 48, n=322, 333 | 3.1 Nanomoles per Liter (nmol/L) | Standard Error 1.1 |
p-value: <0.00195% CI: [-9.9, -3]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-9, -3.4]Mixed Model Repeated Measures
Secondary
Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144
Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor.
Time frame: Baseline (Day 1) and at Week 144
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144 | Serum Osteocalcin, Week 144, n=281, 299 | 0.29 Micrograms per Liter (ug/L) | Standard Error 0.374 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144 | CTX-1, Week 144, n=281, 296 | 0.0750 Micrograms per Liter (ug/L) | Standard Error 0.0115 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144 | Bone-ALP, Week 144, n=281, 295 | -0.25 Micrograms per Liter (ug/L) | Standard Error 0.172 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144 | PINP, Week 144, n=281,299 | 4.6 Micrograms per Liter (ug/L) | Standard Error 1.04 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144 | CTX-1, Week 144, n=281, 296 | 0.2164 Micrograms per Liter (ug/L) | Standard Error 0.01407 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144 | Serum Osteocalcin, Week 144, n=281, 299 | 3.21 Micrograms per Liter (ug/L) | Standard Error 0.403 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144 | PINP, Week 144, n=281,299 | 13.8 Micrograms per Liter (ug/L) | Standard Error 1.14 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144 | Bone-ALP, Week 144, n=281, 295 | 1.43 Micrograms per Liter (ug/L) | Standard Error 0.217 |
p-value: <0.00195% CI: [-2.23, -1.14]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-4, -1.83]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-12.3, -6.2]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-0.1771, -0.1056]Mixed Model Repeated Measures
Secondary
Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96
Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor.
Time frame: Baseline (Day 1) and at Week 96
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96 | Bone-ALP, Week 96, n=296, 317 | 0.30 Micrograms per Liter (ug/L) | Standard Error 0.191 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96 | Serum Osteocalcin, Week 96, n=297, 320 | 0.40 Micrograms per Liter (ug/L) | Standard Error 0.345 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96 | PINP, Week 96, n=297, 319 | 15.0 Micrograms per Liter (ug/L) | Standard Error 1.63 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96 | CTX-1, Week 96, n=297, 315 | 0.1351 Micrograms per Liter (ug/L) | Standard Error 0.0158 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96 | CTX-1, Week 96, n=297, 315 | 0.2943 Micrograms per Liter (ug/L) | Standard Error 0.01916 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96 | Bone-ALP, Week 96, n=296, 317 | 2.37 Micrograms per Liter (ug/L) | Standard Error 0.216 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96 | PINP, Week 96, n=297, 319 | 28.3 Micrograms per Liter (ug/L) | Standard Error 1.5 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96 | Serum Osteocalcin, Week 96, n=297, 320 | 4.57 Micrograms per Liter (ug/L) | Standard Error 0.391 |
p-value: <0.00195% CI: [-2.63, -1.5]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-5.2, -3.14]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-17.6, -8.9]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-0.208, -0.1104]Mixed Model Repeated Measures
Secondary
Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48
Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor.
Time frame: Baseline (Day 1) and at Weeks 24, 48
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 | Bone-ALP, Week 24, n=334, 332 | 0.91 Micrograms per Liter (ug/L) | Standard Error 0.179 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 | Serum Osteocalcin, Week 24, n=335, 334 | 2.56 Micrograms per Liter (ug/L) | Standard Error 0.341 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 | Serum Osteocalcin, Week 48, n=322, 330 | 0.78 Micrograms per Liter (ug/L) | Standard Error 0.311 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 | PINP, Week 24, n=337, 336 | 4.5 Micrograms per Liter (ug/L) | Standard Error 0.91 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 | PINP, Week 48, n=321, 334 | 0.5 Micrograms per Liter (ug/L) | Standard Error 0.83 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 | CTX-1, Week 24, n=337, 334 | 0.1192 Micrograms per Liter (ug/L) | Standard Error 0.01304 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 | CTX-1, Week 48, n=323, 331 | 0.1338 Micrograms per Liter (ug/L) | Standard Error 0.01258 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 | Bone-ALP, Week 48, n=321, 331 | 1.21 Micrograms per Liter (ug/L) | Standard Error 0.193 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 | PINP, Week 24, n=337, 336 | 18.3 Micrograms per Liter (ug/L) | Standard Error 1.06 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 | Bone-ALP, Week 24, n=334, 332 | 3.13 Micrograms per Liter (ug/L) | Standard Error 0.199 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 | Bone-ALP, Week 48, n=321, 331 | 3.79 Micrograms per Liter (ug/L) | Standard Error 0.239 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 | CTX-1, Week 24, n=337, 334 | 0.2820 Micrograms per Liter (ug/L) | Standard Error 0.01472 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 | Serum Osteocalcin, Week 24, n=335, 334 | 6.74 Micrograms per Liter (ug/L) | Standard Error 0.347 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 | PINP, Week 48, n=321, 334 | 13.1 Micrograms per Liter (ug/L) | Standard Error 0.84 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 | Serum Osteocalcin, Week 48, n=322, 330 | 6.01 Micrograms per Liter (ug/L) | Standard Error 0.4 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 | CTX-1, Week 48, n=323, 331 | 0.3352 Micrograms per Liter (ug/L) | Standard Error 0.01885 |
p-value: <0.00195% CI: [-2.75, -1.7]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-3.19, -1.98]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-5.15, -3.23]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-6.22, -4.23]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-16.5, -11.1]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-15, -10.3]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-0.2015, -0.1241]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-0.246, -0.1569]Mixed Model Repeated Measures
Secondary
Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144
EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented.
Time frame: Baseline (Day 1) and Week 144
Population: ITT-E Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144 | 5.2 Scores on a scale | Standard Error 0.48 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144 | 3.0 Scores on a scale | Standard Error 0.5 |
p-value: 0.00195% CI: [0.9, 3.6]MMRM
Secondary
Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96
EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented.
Time frame: Baseline (Day 1) and Week 96
Population: ITT-E Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96 | 4.1 Scores on a scale | Standard Error 0.51 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96 | 2.4 Scores on a scale | Standard Error 0.56 |
p-value: 0.02795% CI: [0.2, 3.2]MMRM
Secondary
Change From Baseline in EQ-5D-5L Utility Score at Week 144
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment (Day 1) and change from Baseline=post-dose value minus Baseline value.
Time frame: Baseline (Day 1) and Week 144
Population: ITT-E Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in EQ-5D-5L Utility Score at Week 144 | 0.0143 Scores on a scale | Standard Error 0.00388 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in EQ-5D-5L Utility Score at Week 144 | 0.0135 Scores on a scale | Standard Error 0.00365 |
p-value: 0.87995% CI: [-0.0097, 0.0113]MMRM
Secondary
Change From Baseline in EQ-5D-5L Utility Score at Week 96
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment (Day 1) and change from Baseline=post-dose value minus Baseline value.
Time frame: Baseline (Day 1) and Week 96
Population: ITT-E Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in EQ-5D-5L Utility Score at Week 96 | 0.0079 Scores on a scale | Standard Error 0.0045 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in EQ-5D-5L Utility Score at Week 96 | 0.0091 Scores on a scale | Standard Error 0.00408 |
p-value: 0.84295% CI: [-0.0132, 0.0107]MMRM
Secondary
Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24 48
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 4, 24, 48
Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24 48 | Week 4, n=349, 348 | 2.3 Scores on a scale | Standard Error 0.48 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24 48 | Week 24, n=352, 350 | 3.7 Scores on a scale | Standard Error 0.54 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24 48 | Week 48, n=352, 350 | 4.3 Scores on a scale | Standard Error 0.49 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24 48 | Week 4, n=349, 348 | 1.2 Scores on a scale | Standard Error 0.52 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24 48 | Week 24, n=352, 350 | 3.2 Scores on a scale | Standard Error 0.51 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24 48 | Week 48, n=352, 350 | 2.8 Scores on a scale | Standard Error 0.49 |
p-value: 0.13795% CI: [-0.3, 2.4]MMRM
p-value: 0.45895% CI: [-0.9, 2]MMRM
p-value: 0.03195% CI: [0.1, 2.8]MMRM
Secondary
Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment (Day 1) and change from Baseline=post-dose value minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 4, 24, 48
Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48 | Week 4, n=349, 348 | 0.0130 Scores on a scale | Standard Error 0.00362 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48 | Week 24, n=352, 351 | 0.0131 Scores on a scale | Standard Error 0.00371 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48 | Week 48, n=352, 351 | 0.0134 Scores on a scale | Standard Error 0.00384 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48 | Week 4, n=349, 348 | 0.0078 Scores on a scale | Standard Error 0.00353 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48 | Week 24, n=352, 351 | 0.0168 Scores on a scale | Standard Error 0.00333 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48 | Week 48, n=352, 351 | 0.0129 Scores on a scale | Standard Error 0.00349 |
p-value: 0.30295% CI: [-0.0047, 0.0152]MMRM
p-value: 0.4595% CI: [-0.0136, 0.006]MMRM
p-value: 0.93495% CI: [-0.0098, 0.0106]MMRM
Secondary
Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144
Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented.
Time frame: Baseline (Day 1) and at Week 144
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144 | -0.229 Ratio | Standard Error 0.0559 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144 | -0.386 Ratio | Standard Error 0.0463 |
Secondary
Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96
Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented.
Time frame: Baseline (Day 1) and at Week 96
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96 | -0.213 Ratio | Standard Error 0.0566 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96 | -0.402 Ratio | Standard Error 0.0479 |
Secondary
Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144
Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented.
Time frame: Baseline (Day 1) and at Week 144
Population: Safety Population. Only those participants available at the specified time points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144 | Serum or Plasma Cholesterol, Week 144, | 0.367 Millimoles per liter | Standard Error 0.0408 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144 | HDL Cholesterol, Direct, Week 144 | 0.181 Millimoles per liter | Standard Error 0.015 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144 | LDL Cholesterol, Week 144, | 0.170 Millimoles per liter | Standard Error 0.0336 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144 | Triglycerides, Week 144 | 0.117 Millimoles per liter | Standard Error 0.0872 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144 | Triglycerides, Week 144 | -0.104 Millimoles per liter | Standard Error 0.0385 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144 | Serum or Plasma Cholesterol, Week 144, | -0.037 Millimoles per liter | Standard Error 0.0406 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144 | LDL Cholesterol, Week 144, | -0.105 Millimoles per liter | Standard Error 0.0348 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144 | HDL Cholesterol, Direct, Week 144 | 0.098 Millimoles per liter | Standard Error 0.0147 |
Secondary
Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96
Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented.
Time frame: Baseline (Day 1) and at Week 96
Population: Safety Population. Only those participants available at the specified time points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96 | Serum or Plasma Cholesterol, Week 96 | 0.379 Millimoles per liter | Standard Error 0.0376 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96 | HDL Cholesterol, Direct, Week 96 | 0.199 Millimoles per liter | Standard Error 0.0156 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96 | LDL Cholesterol, Week 96, | 0.147 Millimoles per liter | Standard Error 0.0338 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96 | Triglycerides, Week 96, | 0.129 Millimoles per liter | Standard Error 0.0835 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96 | Triglycerides, Week 96, | -0.112 Millimoles per liter | Standard Error 0.0358 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96 | Serum or Plasma Cholesterol, Week 96 | -0.104 Millimoles per liter | Standard Error 0.0378 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96 | LDL Cholesterol, Week 96, | -0.154 Millimoles per liter | Standard Error 0.0303 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96 | HDL Cholesterol, Direct, Week 96 | 0.090 Millimoles per liter | Standard Error 0.0149 |
Secondary
Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144
Blood samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error is presented.
Time frame: Baseline (Day 1) and at Week 144
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144 | -0.12 Milligrams per Liter (mg/L) | Standard Error 0.006 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144 | -0.11 Milligrams per Liter (mg/L) | Standard Error 0.007 |
p-value: 0.10895% CI: [-0.03, 0]Mixed Model Repeated Measures
Secondary
Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96
Blood samples were collected to perform evaluation of renal inflammation biomarkers which included Serum Cystatin C . Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor.
Time frame: Baseline (Day 1) and at Week 96
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96 | -0.11 Milligrams per Liter (mg/L) | Standard Error 0.006 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96 | -0.09 Milligrams per Liter (mg/L) | Standard Error 0.006 |
p-value: 0.00995% CI: [-0.04, -0.01]Mixed Model Repeated Measures
Secondary
Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144
Blood and/or urine were collected to perform evaluation of renal inflammation biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor.
Time frame: Baseline (Day 1) and at Week 144
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144 | 12.89 Micromoles per Liter (umol/L) | Standard Error 0.583 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144 | 15.87 Micromoles per Liter (umol/L) | Standard Error 0.56 |
p-value: <0.00195% CI: [-4.57, -1.4]Mixed Model Repeated Measures
Secondary
Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96
Blood and/or urine were collected to perform evaluation of renal inflammation biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor.
Time frame: Baseline (Day 1) and at Week 96
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96 | 12.75 Micromoles per Liter (umol/L) | Standard Error 0.623 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96 | 16.10 Micromoles per Liter (umol/L) | Standard Error 0.539 |
p-value: <0.00195% CI: [-4.96, -1.72]Mixed Model Repeated Measures
Secondary
Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48
Blood and/or urine were collected to perform evaluation of renal inflammation biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor.
Time frame: Baseline (Day 1) and at Weeks 24, 48
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48 | Serum or Plasma Creatinine, Week 24, n=340, 343 | 11.88 Micromoles per Liter (umol/L) | Standard Error 0.51 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48 | Serum or Plasma Creatinine, Week 48, n=326, 335 | 10.39 Micromoles per Liter (umol/L) | Standard Error 0.466 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48 | Serum or Plasma Creatinine, Week 24, n=340, 343 | 15.07 Micromoles per Liter (umol/L) | Standard Error 0.52 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48 | Serum or Plasma Creatinine, Week 48, n=326, 335 | 13.61 Micromoles per Liter (umol/L) | Standard Error 0.48 |
p-value: <0.00195% CI: [-4.62, -1.75]Mixed Model Repeated Measures
p-value: <0.00195% CI: [-4.54, -1.91]Mixed Model Repeated Measures
Secondary
Change From Baseline in Renal Biomarker-Serum RBP at Week 144
Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor.
Time frame: Baseline (Day 1) and at Week 144
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Renal Biomarker-Serum RBP at Week 144 | 1.760 Microgram per millimoles (ug/mmol) | Standard Deviation 5.7909 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Renal Biomarker-Serum RBP at Week 144 | 8.855 Microgram per millimoles (ug/mmol) | Standard Deviation 35.5147 |
Secondary
Change From Baseline in Renal Biomarker-Serum RBP at Week 96
Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor.
Time frame: Baseline (Day 1) and at Week 96
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Renal Biomarker-Serum RBP at Week 96 | 1.535 Microgram per millimoles (ug/mmol) | Standard Deviation 8.5872 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Renal Biomarker-Serum RBP at Week 96 | 7.704 Microgram per millimoles (ug/mmol) | Standard Deviation 41.965 |
Secondary
Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Serum Cystatin C and Serum Retinol Binding Protein (RBP). Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor.
Time frame: Baseline (Day 1) and at Weeks 24, 48
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48 | Serum RBP, Week 24, n=332, 334 | 1.6 Milligrams per Liter (mg/L) | Standard Error 0.41 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48 | Serum Cystatin C, Week 24, n=338, 336 | -0.05 Milligrams per Liter (mg/L) | Standard Error 0.007 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48 | Serum RBP, Week 48, n=322, 332 | 0.5 Milligrams per Liter (mg/L) | Standard Error 0.47 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48 | Serum Cystatin C, Week 48, n=324, 332 | -0.07 Milligrams per Liter (mg/L) | Standard Error 0.007 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48 | Serum Cystatin C, Week 48, n=324, 332 | -0.04 Milligrams per Liter (mg/L) | Standard Error 0.006 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48 | Serum RBP, Week 24, n=332, 334 | 1.9 Milligrams per Liter (mg/L) | Standard Error 0.51 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48 | Serum RBP, Week 48, n=322, 332 | 0.6 Milligrams per Liter (mg/L) | Standard Error 0.46 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48 | Serum Cystatin C, Week 24, n=338, 336 | -0.03 Milligrams per Liter (mg/L) | Standard Error 0.007 |
p-value: 0.02595% CI: [-0.04, 0]Mixed Model Repeated Measures
p-value: 0.00195% CI: [-0.05, -0.01]Mixed Model Repeated Measures
p-value: 0.68395% CI: [-1.6, 1]Mixed Model Repeated Measures
p-value: 0.9395% CI: [-1.4, 1.2]Mixed Model Repeated Measures
Secondary
Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI (GFR-cystatin C adjusted)and Serum or Plasma GFR from creatinine adjusted using CKD-EPI. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor.
Time frame: Baseline (Day 1) and at Weeks 24, 48
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48 | GFR-cystatin C adjusted, Week 48, n=324, 332 | 7.0 Milliliter/minute/1.73*meter^2 | Standard Error 0.6 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48 | GFR-creatinine adjusted, Week 48, n=326,335 | -12.1 Milliliter/minute/1.73*meter^2 | Standard Error 0.56 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48 | GFR-creatinine adjusted, Week 24, n=340, 341 | -13.5 Milliliter/minute/1.73*meter^2 | Standard Error 0.59 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48 | GFR-cystatin C adjusted, Week 24, n=338, 336 | 4.4 Milliliter/minute/1.73*meter^2 | Standard Error 0.63 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48 | GFR-cystatin C adjusted, Week 48, n=324, 332 | 4.1 Milliliter/minute/1.73*meter^2 | Standard Error 0.59 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48 | GFR-cystatin C adjusted, Week 24, n=338, 336 | 2.2 Milliliter/minute/1.73*meter^2 | Standard Error 0.6 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48 | GFR-creatinine adjusted, Week 24, n=340, 341 | -16.7 Milliliter/minute/1.73*meter^2 | Standard Error 0.56 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48 | GFR-creatinine adjusted, Week 48, n=326,335 | -15.6 Milliliter/minute/1.73*meter^2 | Standard Error 0.55 |
p-value: 0.01195% CI: [0.5, 4]Mixed Model Repeated Measures
p-value: <0.00195% CI: [1.2, 4.5]Mixed Model Repeated Measures
p-value: <0.00195% CI: [1.6, 4.8]Mixed Model Repeated Measures
p-value: <0.00195% CI: [2, 5.1]Mixed Model Repeated Measures
Secondary
Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144
Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor.
Time frame: Baseline (Day 1) and at Week 144
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144 | GFR Cystatin C adjusted, Week 144, n=283,298 | 13.0 Milliliter/minute/1.73*meter^2 | Standard Deviation 13.64 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144 | GFR creatinine adjusted, Week 144, n=271, 289 | -16.7 Milliliter/minute/1.73*meter^2 | Standard Deviation 11.65 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144 | GFR Cystatin C adjusted, Week 144, n=283,298 | 12.1 Milliliter/minute/1.73*meter^2 | Standard Deviation 15.24 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144 | GFR creatinine adjusted, Week 144, n=271, 289 | -19.3 Milliliter/minute/1.73*meter^2 | Standard Deviation 11.07 |
Secondary
Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96
Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor.
Time frame: Baseline (Day 1) and at Week 96
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96 | GFR creatinine adjusted, Week 96 | -15.3 Milliliter/minute/1.73*meter^2 | Standard Deviation 11.5 |
| DTG + 3TC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96 | GFR Cystatin C adjusted, Week 96 | 11.3 Milliliter/minute/1.73*meter^2 | Standard Deviation 14.54 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96 | GFR Cystatin C adjusted, Week 96 | 9.3 Milliliter/minute/1.73*meter^2 | Standard Deviation 13.78 |
| DTG + TDF/FTC-Double Blind Phase | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96 | GFR creatinine adjusted, Week 96 | -19.0 Milliliter/minute/1.73*meter^2 | Standard Deviation 11.25 |
Secondary
Changes From Baseline in CD4+ Cell Counts at Week 144
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor.
Time frame: Baseline (Day 1) and Week 144
Population: ITT-E Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 | 301.8 Cells per cubic millimeter | Standard Error 11.51 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 | 303.2 Cells per cubic millimeter | Standard Error 12.13 |
p-value: 0.93495% CI: [-34.2, 31.5]Mixed Model Repeated Measures (MMRM)
Secondary
Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only.
Time frame: Baseline (Day 1) and Week 144
Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Baseline CD4+ cell count,<=200, n=17, 24 | 290.2 Cells per cubic millimeter | Standard Error 50.44 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Female, n=43, 43 | 346.6 Cells per cubic millimeter | Standard Error 31.4 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Age group, <35,n=155, 167 | 298.0 Cells per cubic millimeter | Standard Error 16.59 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Male, n=227, 244 | 295.9 Cells per cubic millimeter | Standard Error 13.66 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Baseline plasma HIV-1 RNA,>100000, n=56, 64 | 334.3 Cells per cubic millimeter | Standard Error 27.77 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Race group, White, n=190,201 | 314.2 Cells per cubic millimeter | Standard Error 14.93 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Age group-1, 35 to <50, n=92, 87 | 305.6 Cells per cubic millimeter | Standard Error 21.48 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Race group, African Am/African H., n=26, 26 | 243.8 Cells per cubic millimeter | Standard Error 40.42 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Baseline CD4+ cell count,>200, n=253, 263 | 304.7 Cells per cubic millimeter | Standard Error 12.97 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Race group, Asian, n=26, 34 | 244.0 Cells per cubic millimeter | Standard Error 40.47 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Age group-1, >=50, n=23,33 | 337.4 Cells per cubic millimeter | Standard Error 43.01 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Race group, Other, n=28,26 | 346.2 Cells per cubic millimeter | Standard Error 38.87 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Baseline plasma HIV-1 RNA,<=100000, n=214,223 | 295.7 Cells per cubic millimeter | Standard Error 14.14 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Race group, Other, n=28,26 | 279.9 Cells per cubic millimeter | Standard Error 40.42 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Baseline plasma HIV-1 RNA,<=100000, n=214,223 | 296.1 Cells per cubic millimeter | Standard Error 13.84 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Baseline plasma HIV-1 RNA,>100000, n=56, 64 | 329.6 Cells per cubic millimeter | Standard Error 26.15 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Baseline CD4+ cell count,<=200, n=17, 24 | 272.9 Cells per cubic millimeter | Standard Error 42.29 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Baseline CD4+ cell count,>200, n=253, 263 | 306.2 Cells per cubic millimeter | Standard Error 12.71 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Age group, <35,n=155, 167 | 316.0 Cells per cubic millimeter | Standard Error 15.93 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Age group-1, 35 to <50, n=92, 87 | 302.1 Cells per cubic millimeter | Standard Error 22.11 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Age group-1, >=50, n=23,33 | 242.2 Cells per cubic millimeter | Standard Error 35.83 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Female, n=43, 43 | 321.7 Cells per cubic millimeter | Standard Error 31.67 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Male, n=227, 244 | 300.0 Cells per cubic millimeter | Standard Error 13.2 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Race group, White, n=190,201 | 314.0 Cells per cubic millimeter | Standard Error 14.53 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Race group, African Am/African H., n=26, 26 | 295.1 Cells per cubic millimeter | Standard Error 40.39 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Race group, Asian, n=26, 34 | 264.1 Cells per cubic millimeter | Standard Error 35.41 |
95% CI: [-39.2, 38.3]
95% CI: [-69.4, 78.8]
95% CI: [-111.1, 145.8]
95% CI: [-37.2, 34.1]
95% CI: [-63.2, 27.1]
95% CI: [-57, 64]
95% CI: [-14.8, 205.2]
95% CI: [-62.5, 112.3]
95% CI: [-41.5, 33.1]
95% CI: [-40.6, 41.1]
95% CI: [-163.6, 60.9]
95% CI: [-125.3, 85]
95% CI: [-43.7, 176.2]
Secondary
Changes From Baseline in CD4+ Cell Counts at Week 24 and 48
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor.
Time frame: Baseline (Day 1) and Weeks 24, 48
Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 and 48 | Week 24, n=340,341 | 192.2 Cells per cubic millimeter | Standard Error 9.67 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 and 48 | Week 48, n=324,334 | 222.2 Cells per cubic millimeter | Standard Error 9.87 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 and 48 | Week 24, n=340,341 | 175.1 Cells per cubic millimeter | Standard Error 9.41 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 and 48 | Week 48, n=324,334 | 217.7 Cells per cubic millimeter | Standard Error 10.64 |
p-value: 0.20695% CI: [-9.4, 43.6]Mixed Model Repeated Measures (MMRM)
p-value: 0.75495% CI: [-23.9, 33]Mixed Model Repeated Measures (MMRM)
Secondary
Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age, Gender, and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only.
Time frame: Baseline (Day 1) and Week 24
Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Age, >=50, n=28, 42 | 188.79 Cells per cubic millimeter | Standard Error 33.534 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Female, n=57,50 | 199.45 Cells per cubic millimeter | Standard Error 23.498 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Baseline plasma HIV-1 RNA,<=100000, n=268,268 | 187.72 Cells per cubic millimeter | Standard Error 10.86 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Baseline plasma HIV-1 RNA,>100000, n=72,73 | 206.63 Cells per cubic millimeter | Standard Error 21.107 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Baseline CD4+ cell count,<=200, n=29,27 | 157.01 Cells per cubic millimeter | Standard Error 33.113 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Baseline CD4+ cell count,>200, n=311, 314 | 195.11 Cells per cubic millimeter | Standard Error 10.026 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Age, <35,n= 203,199 | 202.76 Cells per cubic millimeter | Standard Error 12.456 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Age, 35 to <50, n=109, 100 | 172.05 Cells per cubic millimeter | Standard Error 16.983 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Male, n=283,291 | 190.21 Cells per cubic millimeter | Standard Error 10.538 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Race, White, n=236,235 | 204.78 Cells per cubic millimeter | Standard Error 11.531 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Race, African Am/African H., n=36,33 | 143.84 Cells per cubic millimeter | Standard Error 29.541 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Race, Asian, n=34, 41 | 169.80 Cells per cubic millimeter | Standard Error 30.491 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Race, Other, n=34,32 | 174.30 Cells per cubic millimeter | Standard Error 30.375 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Race, Asian, n=34, 41 | 165.36 Cells per cubic millimeter | Standard Error 27.782 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Age, 35 to <50, n=109, 100 | 179.87 Cells per cubic millimeter | Standard Error 17.733 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Race, White, n=236,235 | 182.27 Cells per cubic millimeter | Standard Error 11.582 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Age, >=50, n=28, 42 | 159.34 Cells per cubic millimeter | Standard Error 27.344 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Baseline plasma HIV-1 RNA,<=100000, n=268,268 | 167.93 Cells per cubic millimeter | Standard Error 10.842 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Female, n=57,50 | 181.78 Cells per cubic millimeter | Standard Error 25.263 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Baseline plasma HIV-1 RNA,>100000, n=72,73 | 205.96 Cells per cubic millimeter | Standard Error 20.99 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Race, African Am/African H., n=36,33 | 170.51 Cells per cubic millimeter | Standard Error 30.87 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Baseline CD4+ cell count,<=200, n=29,27 | 120.17 Cells per cubic millimeter | Standard Error 34.151 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Male, n=283,291 | 175.05 Cells per cubic millimeter | Standard Error 10.4 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Baseline CD4+ cell count,>200, n=311, 314 | 180.73 Cells per cubic millimeter | Standard Error 9.972 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Race, Other, n=34,32 | 149.34 Cells per cubic millimeter | Standard Error 31.404 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Age, <35,n= 203,199 | 177.62 Cells per cubic millimeter | Standard Error 12.563 |
95% CI: [-10.23, 49.83]
95% CI: [-57.07, 58.4]
95% CI: [-55.94, 129.63]
95% CI: [-13.38, 42.12]
95% CI: [-9.56, 59.85]
95% CI: [-55.98, 40.34]
95% CI: [-55.47, 114.38]
95% CI: [-49.89, 85.23]
95% CI: [-13.9, 44.21]
95% CI: [-9.52, 54.54]
95% CI: [-110.64, 57.3]
95% CI: [-76.18, 85.06]
95% CI: [-60.68, 110.59]
Secondary
Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from Analysis of Covariance (ANCOVA) model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only.
Time frame: Baseline (Day 1) and Week 48
Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Baseline CD4+ cell count,<=200, n=26, 27 | 200.5 Cells per cubic millimeter | Standard Error 36.97 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Female, n=54, 49 | 237.1 Cells per cubic millimeter | Standard Error 25.53 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Age group-1, <35,n= 194, 192 | 233.6 Cells per cubic millimeter | Standard Error 13.49 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Male, n=270, 285 | 221.2 Cells per cubic millimeter | Standard Error 11.41 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Baseline plasma HIV-1 RNA,>100000, n=67,70 | 238.5 Cells per cubic millimeter | Standard Error 23.09 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Race, White, n=224, 231 | 226.0 Cells per cubic millimeter | Standard Error 12.55 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Age group-1, 35 to <50, n=104, 101 | 208.7 Cells per cubic millimeter | Standard Error 18.4 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Race, African Am/African H., n=33, 31 | 209.4 Cells per cubic millimeter | Standard Error 32.75 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Baseline CD4+ cell count,>200, n=298, 307 | 225.9 Cells per cubic millimeter | Standard Error 10.84 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Race, Asian, n=34, 41 | 246.4 Cells per cubic millimeter | Standard Error 32.35 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Age group-1, >=50, n=26, 41 | 212.6 Cells per cubic millimeter | Standard Error 36.84 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Race, Other, n=33, 31 | 200.2 Cells per cubic millimeter | Standard Error 32.69 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Baseline plasma HIV-1 RNA,<=100000, n=257,264 | 220.0 Cells per cubic millimeter | Standard Error 11.72 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Race, Other, n=33, 31 | 202.7 Cells per cubic millimeter | Standard Error 33.83 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Baseline plasma HIV-1 RNA,<=100000, n=257,264 | 212.4 Cells per cubic millimeter | Standard Error 11.56 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Baseline plasma HIV-1 RNA,>100000, n=67,70 | 235.5 Cells per cubic millimeter | Standard Error 22.7 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Baseline CD4+ cell count,<=200, n=26, 27 | 177.9 Cells per cubic millimeter | Standard Error 36.18 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Baseline CD4+ cell count,>200, n=298, 307 | 220.7 Cells per cubic millimeter | Standard Error 10.68 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Age group-1, <35,n= 194, 192 | 225.2 Cells per cubic millimeter | Standard Error 13.53 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Age group-1, 35 to <50, n=104, 101 | 211.2 Cells per cubic millimeter | Standard Error 18.67 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Age group-1, >=50, n=26, 41 | 194.8 Cells per cubic millimeter | Standard Error 29.27 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Female, n=54, 49 | 226.8 Cells per cubic millimeter | Standard Error 26.98 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Male, n=270, 285 | 215.6 Cells per cubic millimeter | Standard Error 11.11 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Race, White, n=224, 231 | 219.7 Cells per cubic millimeter | Standard Error 12.39 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Race, African Am/African H., n=33, 31 | 239.9 Cells per cubic millimeter | Standard Error 33.79 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Race, Asian, n=34, 41 | 197.2 Cells per cubic millimeter | Standard Error 29.47 |
95% CI: [-24.6, 39.8]
95% CI: [-59.8, 65.9]
95% CI: [-78.3, 123.5]
95% CI: [-24.7, 35.1]
95% CI: [-29.1, 45.9]
95% CI: [-53.9, 48.9]
95% CI: [-74.6, 110.1]
95% CI: [-62.3, 83.1]
95% CI: [-25.6, 36.9]
95% CI: [-28.2, 40.9]
95% CI: [-122.7, 62.4]
95% CI: [-36.3, 134.7]
95% CI: [-94.7, 89.7]
Secondary
Changes From Baseline in CD4+ Cell Counts at Week 96
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor.
Time frame: Baseline (Day 1) and Week 96
Population: ITT-E Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 | 264.7 Cells per cubic millimeter | Standard Error 11.32 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 | 253.8 Cells per cubic millimeter | Standard Error 11.4 |
p-value: 0.595% CI: [-20.7, 42.4]Mixed Model Repeated Measures (MMRM)
Secondary
Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only.
Time frame: Baseline (Day 1) and Week 96
Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Baseline CD4+ cell count,<=200, n=21,26 | 240.5 Cells per cubic millimeter | Standard Error 45.16 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Female, n=49,46 | 277.9 Cells per cubic millimeter | Standard Error 29.4 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Age group-1, <35,n= 179,185 | 270.2 Cells per cubic millimeter | Standard Error 15.38 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Male, n=252, 274 | 261.4 Cells per cubic millimeter | Standard Error 12.95 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Baseline plasma HIV-1 RNA,>100000, n=61,67 | 300.2 Cells per cubic millimeter | Standard Error 26.5 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Race group, White, n=210,223 | 275.2 Cells per cubic millimeter | Standard Error 14.21 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Age group-1, 35 to <50, n=97,95 | 259.5 Cells per cubic millimeter | Standard Error 20.86 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Race group, African Am/African H., n=31,29 | 228.5 Cells per cubic millimeter | Standard Error 37.07 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Baseline CD4+ cell count,>200, n=280,294 | 265.9 Cells per cubic millimeter | Standard Error 12.28 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Race group, Asian, n=29,38 | 212.1 Cells per cubic millimeter | Standard Error 38.34 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Age group-1, >=50, n=25, 40 | 237.6 Cells per cubic millimeter | Standard Error 41.11 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Race group, Other, n=31,30 | 273.4 Cells per cubic millimeter | Standard Error 36.97 |
| DTG + 3TC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Baseline plasma HIV-1 RNA,<=100000, n=240,253 | 254.8 Cells per cubic millimeter | Standard Error 13.3 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Race group, Other, n=31,30 | 247.3 Cells per cubic millimeter | Standard Error 37.67 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Baseline plasma HIV-1 RNA,<=100000, n=240,253 | 252.9 Cells per cubic millimeter | Standard Error 12.93 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Baseline plasma HIV-1 RNA,>100000, n=61,67 | 260.1 Cells per cubic millimeter | Standard Error 25.42 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Baseline CD4+ cell count,<=200, n=21,26 | 244.4 Cells per cubic millimeter | Standard Error 40.44 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Baseline CD4+ cell count,>200, n=280,294 | 255.1 Cells per cubic millimeter | Standard Error 11.98 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Age group-1, <35,n= 179,185 | 263.0 Cells per cubic millimeter | Standard Error 15.09 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Age group-1, 35 to <50, n=97,95 | 262.0 Cells per cubic millimeter | Standard Error 21.09 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Age group-1, >=50, n=25, 40 | 195.9 Cells per cubic millimeter | Standard Error 32.45 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Female, n=49,46 | 259.1 Cells per cubic millimeter | Standard Error 30.54 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Male, n=252, 274 | 253.5 Cells per cubic millimeter | Standard Error 12.43 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Race group, White, n=210,223 | 260.0 Cells per cubic millimeter | Standard Error 13.8 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Race group, African Am/African H., n=31,29 | 230.2 Cells per cubic millimeter | Standard Error 38.23 |
| DTG + TDF/FTC-Double Blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Race group, Asian, n=29,38 | 244.8 Cells per cubic millimeter | Standard Error 33.53 |
95% CI: [-34.5, 38.2]
95% CI: [-31.2, 111.5]
95% CI: [-122.3, 114.5]
95% CI: [-22.9, 44.5]
95% CI: [-35, 49.6]
95% CI: [-60.7, 55.7]
95% CI: [-61.2, 144.5]
95% CI: [-64.2, 101.8]
95% CI: [-27.4, 43.1]
95% CI: [-23.6, 54]
95% CI: [-106.3, 103]
95% CI: [-132.2, 66.9]
95% CI: [-77.3, 129.5]
Secondary
Number of Participants Who Discontinue Treatment Due to AEs Over Week 144
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to AEs have been reported.
Time frame: Up to Week 144
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DTG + 3TC-Double Blind Phase | Number of Participants Who Discontinue Treatment Due to AEs Over Week 144 | 18 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants Who Discontinue Treatment Due to AEs Over Week 144 | 17 Participants |
Secondary
Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. . Number of participants who discontinued treatment due to AEs have been reported.
Time frame: Up to Week 24, Week 48 and Week 96
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96 | Up to Week 24 | 6 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96 | Up to Week 48 | 7 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96 | Up to Week 96 | 14 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96 | Up to Week 24 | 4 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96 | Up to Week 48 | 8 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96 | Up to Week 96 | 11 Participants |
Secondary
Number of Participants With AEs by Maximum Severity Grades up to Week 144
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.
Time frame: Up to Week 144
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Number of Participants With AEs by Maximum Severity Grades up to Week 144 | Grade 2 AEs | 229 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With AEs by Maximum Severity Grades up to Week 144 | Grade 4 AEs | 7 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With AEs by Maximum Severity Grades up to Week 144 | Grade 3 AEs | 37 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With AEs by Maximum Severity Grades up to Week 144 | Grade 5 AEs | 1 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With AEs by Maximum Severity Grades up to Week 144 | Grade 1 AEs | 33 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With AEs by Maximum Severity Grades up to Week 144 | Grade 5 AEs | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With AEs by Maximum Severity Grades up to Week 144 | Grade 1 AEs | 35 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With AEs by Maximum Severity Grades up to Week 144 | Grade 2 AEs | 242 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With AEs by Maximum Severity Grades up to Week 144 | Grade 3 AEs | 34 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With AEs by Maximum Severity Grades up to Week 144 | Grade 4 AEs | 5 Participants |
Secondary
Number of Participants With Any AE and SAE up to Week 148
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or protocol defined event associated with liver injury and impaired liver function were categorized as SAE. Safety Population was used which comprised of all participants who received at least one dose of study treatment.
Time frame: Up to Week 148
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Number of Participants With Any AE and SAE up to Week 148 | Any AE | 307 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Any AE and SAE up to Week 148 | Any SAE | 37 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Any AE and SAE up to Week 148 | Any AE | 316 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Any AE and SAE up to Week 148 | Any SAE | 38 Participants |
Secondary
Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 144
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5. (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with drug related AEs and drug related AEs by by maximum grade have been presented.
Time frame: Up to Week 144
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 144 | Any drug related AE | 77 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 144 | Drug related AEs with maximum toxicity Grade 1 | 51 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 144 | Drug related AEs with maximum toxicity Grade 2 | 19 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 144 | Drug related AEs with maximum toxicity Grade 3 | 7 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 144 | Drug related AEs with maximum toxicity Grade 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 144 | Drug related AEs with maximum toxicity Grade 5 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 144 | Drug related AEs with maximum toxicity Grade 3 | 3 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 144 | Any drug related AE | 101 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 144 | Drug related AEs with maximum toxicity Grade 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 144 | Drug related AEs with maximum toxicity Grade 5 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 144 | Drug related AEs with maximum toxicity Grade 2 | 28 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 144 | Drug related AEs with maximum toxicity Grade 1 | 70 Participants |
Secondary
Number of Participants With HIV-1 Disease Progression up to Week 144
HIV-associated conditions were recorded during the study and was assessed according to the 2014 Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. Disease progressions summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrolment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrolment to Death.
Time frame: Up to Week 144
Population: ITT-E Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Number of Participants With HIV-1 Disease Progression up to Week 144 | From CDC Stage 2 to CDC Stage 3 Event | 2 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With HIV-1 Disease Progression up to Week 144 | From CDC Stage 1 to CDC Stage 3 Event | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With HIV-1 Disease Progression up to Week 144 | From CDC Stage 3 to New CDC Stage 3 Event | 1 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With HIV-1 Disease Progression up to Week 144 | From CDC Stage 1, 2 or 3 to Death | 1 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With HIV-1 Disease Progression up to Week 144 | No HIV-1 disease progression | 352 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With HIV-1 Disease Progression up to Week 144 | From CDC Stage 1, 2 or 3 to Death | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With HIV-1 Disease Progression up to Week 144 | No HIV-1 disease progression | 356 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With HIV-1 Disease Progression up to Week 144 | From CDC Stage 1 to CDC Stage 3 Event | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With HIV-1 Disease Progression up to Week 144 | From CDC Stage 2 to CDC Stage 3 Event | 2 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With HIV-1 Disease Progression up to Week 144 | From CDC Stage 3 to New CDC Stage 3 Event | 0 Participants |
Secondary
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144
Blood samples were collected up to Week 144 for assessment of Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate aminotransferase (AST), Bilirubin, Carbon dioxide (CO2), Cholesterol, Creatine kinase (CK), Creatinine, Direct Bilirubin, Glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), Hypercalcemia, Hyperglycemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycemia, Hypokalemia, Hyponatremia, Low density lipid (LDL) Cholesterol, Lactate Dehydrogenase, Lipase, Phosphate, and Triglycerides. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent chemistry toxicities in any of the chemistry parameters have been presented
Time frame: Up to Week 144
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALT, Grade 4 | 7 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Bilirubin, Grade 1 | 28 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR from creatinine adjusted for BSA Grades 1 to 4 | 185 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR from creatinine adjusted for BSA Grades 2 to 4 | 185 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR from creatinine adjusted for BSA Grades 3 to 4 | 13 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR from creatinine adjusted for BSA, Grade 1 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR from creatinine adjusted for BSA, Grade 2 | 172 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR from creatinine adjusted for BSA Grades 3 | 13 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR from creatinine adjusted for BSA, Grade 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypercalcaemia, Grades 2 to 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypercalcaemia, Grade 1 | 7 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypercalcaemia, Grade 2 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypercalcaemia, Grade 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycemia, Grades 1 to 4 | 91 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycemia, Grades 2 to 4 | 38 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycemia, Grades 3 to 4 | 3 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycemia, Grade 1 | 53 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycemia, Grade 2 | 35 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycemia, Grade 3 | 3 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperkalemia, Grades 1 to 4 | 1 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperkalemia, Grades 2 to 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperkalemia, Grades 3 to 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperkalemia, Grade 1 | 1 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperkalemia, Grade 2 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperkalemia, Grade 3 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperkalemia, Grade 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypernatremia, Grades 1 to 4 | 6 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypernatremia, Grades 2 to 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypernatremia, Grades 3 to 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypernatremia, Grade 1 | 6 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypernatremia, Grade 2 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypernatremia, Grade 3 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypernatremia, Grade 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypocalcaemia, Grades 1 to 4 | 14 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypocalcaemia, Grades 2 to 4 | 4 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypocalcaemia, Grades 3 to 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypocalcaemia, Grade 1 | 10 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypocalcaemia, Grade 2 | 4 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypocalcaemia, Grade 3 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypocalcaemia, Grade 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycemia, Grades 1 to 4 | 22 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycemia, Grades 2 to 4 | 8 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycemia, Grades 3 to 4 | 2 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycemia, Grade 1 | 14 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycemia, Grade 2 | 6 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycemia, Grade 3 | 1 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycemia, Grade 4 | 1 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypokalemia, Grades 3 to 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypokalemia, Grade 1 | 6 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypokalemia, Grade 2 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypokalemia, Grade 3 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypokalemia, Grade 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyponatremia, Grades 1 to 4 | 25 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyponatremia, Grades 3 to 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyponatremia, Grade 1 | 23 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyponatremia, Grade 2 | 2 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyponatremia, Grade 3 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyponatremia, Grade 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | LDL Cholesterol, Grades 1 to 4 | 57 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | LDL Cholesterol, Grades 2 to 4 | 17 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | LDL Cholesterol, Grades 3 to 4 | 5 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lactate Dehydrogenase, Grades 3 to 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grades 1 to 4 | 65 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grade 2 | 25 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grade 3 | 8 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grade 4 | 2 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Phosphate, Grades 1 to 4 | 70 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Phosphate, Grades 2 to 4 | 35 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Phosphate, Grades 3 to 4 | 2 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Phosphate, Grade 1 | 35 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Phosphate, Grade 2 | 33 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Phosphate, Grade 3 | 2 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Phosphate, Grade 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Direct Bilirubin, Grades 1 to 4 | 14 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Triglycerides, Grades 1 to 4 | 80 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Triglycerides, Grades 2 to 4 | 12 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Triglycerides, Grades 3 to 4 | 7 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Triglycerides, Grade 1 | 68 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Triglycerides, Grade 2 | 5 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Triglycerides, Grade 3 | 6 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Triglycerides, Grade 4 | 1 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Direct Bilirubin, Grades 2 to 4 | 14 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Direct Bilirubin, Grade 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Direct Bilirubin, Grades 3 to 4 | 14 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Direct Bilirubin, Grade 1 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Direct Bilirubin, Grade 2 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Direct Bilirubin, Grade 3 | 14 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALT, Grades 1 to 4 | 55 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALT, Grades 2 to 4 | 23 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALT, Grades 3 to 4 | 14 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALT, Grade 1 | 32 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALT, Grade 2 | 9 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALT, Grade 3 | 7 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Albumin, Grades 1 to 4 | 1 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Albumin, Grades 2 to 4 | 1 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Albumin, Grades 3 to 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Albumin, Grade 1 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Albumin, Grade 2 | 1 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Albumin, Grade 3 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Albumin, Grade 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALP, Grades 1 to 4 | 8 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALP, Grades 2 to 4 | 3 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALP, Grades 3 to 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALP, Grade 1 | 5 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALP, Grade 2 | 3 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALP, Grade 3 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALP, Grade 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | AST, Grades 1 to 4 | 52 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | AST, Grades 2 to 4 | 27 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | AST, Grades 3 to 4 | 8 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | AST, Grade 1 | 25 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | AST, Grade 2 | 19 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | AST, Grade 3 | 6 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | AST, Grade 4 | 2 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Bilirubin, Grades 1 to 4 | 42 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Bilirubin, Grades 2 to 4 | 14 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Bilirubin, Grades 3 to 4 | 4 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Bilirubin, Grade 2 | 10 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Bilirubin, Grade 3 | 2 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Bilirubin, Grade 4 | 2 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CO2, Grades 1 to 4 | 126 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CO2, Grades 2 to 4 | 8 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CO2, Grades 3 to 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CO2, Grade 1 | 118 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CO2, Grade 2 | 8 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CO2, Grade 3 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CO2, Grade 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Cholesterol, Grades 1 to 4 | 77 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Cholesterol, Grades 2 to 4 | 24 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Cholesterol, Grades 3 to 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Cholesterol, Grade 1 | 53 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Cholesterol, Grade 2 | 24 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Cholesterol, Grade 3 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Cholesterol, Grade 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grades 1 to 4 | 76 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grades 2 to 4 | 43 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grades 3 to 4 | 26 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grade 1 | 33 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grade 2 | 17 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grade 3 | 15 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grade 4 | 11 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Creatinine, Grades 1 to 4 | 21 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Creatinine, Grades 2 to 4 | 1 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Creatinine, Grades 3 to 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Creatinine, Grade 1 | 20 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Creatinine, Grade 2 | 1 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Creatinine, Grade 3 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Creatinine, Grade 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypercalcaemia, Grades 1 to 4 | 7 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypercalcaemia, Grades 3 to 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypercalcaemia, Grade 3 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycemia, Grade 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypokalemia, Grades 1 to 4 | 6 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypokalemia, Grades 2 to 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyponatremia, Grades 2 to 4 | 2 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | LDL Cholesterol, Grade 1 | 40 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | LDL Cholesterol, Grade 2 | 12 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | LDL Cholesterol, Grade 3 | 5 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | LDL Cholesterol, Grade 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lactate Dehydrogenase, Grades 1 to 4 | 3 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lactate Dehydrogenase, Grades 2 to 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lactate Dehydrogenase, Grade 1 | 3 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lactate Dehydrogenase, Grade 2 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lactate Dehydrogenase, Grade 3 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lactate Dehydrogenase, Grade 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grades 2 to 4 | 35 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grades 3 to 4 | 10 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grade 1 | 30 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CO2, Grades 3 to 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALP, Grade 3 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Creatinine, Grade 1 | 28 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grade 1 | 23 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Creatinine, Grades 3 to 4 | 2 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Direct Bilirubin, Grade 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Direct Bilirubin, Grades 2 to 4 | 13 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR from creatinine adjusted for BSA Grades 1 to 4 | 226 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CO2, Grade 1 | 107 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR from creatinine adjusted for BSA Grades 2 to 4 | 226 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Direct Bilirubin, Grades 3 to 4 | 13 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR from creatinine adjusted for BSA Grades 3 to 4 | 27 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lactate Dehydrogenase, Grade 2 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR from creatinine adjusted for BSA, Grade 1 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Direct Bilirubin, Grade 1 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR from creatinine adjusted for BSA, Grade 2 | 199 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CO2, Grade 2 | 9 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR from creatinine adjusted for BSA Grades 3 | 25 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Creatinine, Grade 2 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR from creatinine adjusted for BSA, Grade 4 | 2 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypercalcaemia, Grades 1 to 4 | 4 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CO2, Grade 3 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypercalcaemia, Grades 2 to 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypercalcaemia, Grades 3 to 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALT, Grades 1 to 4 | 81 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | LDL Cholesterol, Grade 3 | 4 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypercalcaemia, Grade 2 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypercalcaemia, Grade 3 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALT, Grades 2 to 4 | 25 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypercalcaemia, Grade 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CO2, Grade 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycemia, Grades 1 to 4 | 81 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALT, Grades 3 to 4 | 9 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycemia, Grades 2 to 4 | 25 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Creatinine, Grade 3 | 2 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycemia, Grades 3 to 4 | 2 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALT, Grade 1 | 56 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Cholesterol, Grades 1 to 4 | 40 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALT, Grade 2 | 16 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycemia, Grade 3 | 2 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycemia, Grade 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grades 3 to 4 | 18 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperkalemia, Grades 1 to 4 | 4 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALT, Grade 3 | 4 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperkalemia, Grades 2 to 4 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALT, Grade 4 | 5 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperkalemia, Grades 3 to 4 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Cholesterol, Grades 2 to 4 | 13 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperkalemia, Grade 1 | 3 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Albumin, Grades 1 to 4 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperkalemia, Grade 2 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | LDL Cholesterol, Grade 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperkalemia, Grade 3 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Albumin, Grades 2 to 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperkalemia, Grade 4 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Cholesterol, Grades 3 to 4 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypernatremia, Grades 1 to 4 | 3 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Albumin, Grades 3 to 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypernatremia, Grades 2 to 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lactate Dehydrogenase, Grade 3 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypernatremia, Grades 3 to 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Albumin, Grade 1 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypernatremia, Grade 1 | 3 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Cholesterol, Grade 1 | 27 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypernatremia, Grade 2 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Albumin, Grade 2 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypernatremia, Grade 3 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypercalcaemia, Grade 1 | 4 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypernatremia, Grade 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Albumin, Grade 3 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypocalcaemia, Grades 1 to 4 | 13 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Cholesterol, Grade 2 | 12 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypocalcaemia, Grades 2 to 4 | 3 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Albumin, Grade 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypocalcaemia, Grades 3 to 4 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lactate Dehydrogenase, Grades 1 to 4 | 5 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALP, Grades 1 to 4 | 10 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypocalcaemia, Grade 2 | 2 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Cholesterol, Grade 3 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypocalcaemia, Grade 3 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALP, Grades 2 to 4 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypocalcaemia, Grade 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycemia, Grade 1 | 56 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycemia, Grades 1 to 4 | 17 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALP, Grades 3 to 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycemia, Grades 2 to 4 | 3 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Cholesterol, Grade 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycemia, Grades 3 to 4 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALP, Grade 1 | 9 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycemia, Grade 1 | 14 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycemia, Grade 2 | 23 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycemia, Grade 2 | 2 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALP, Grade 2 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycemia, Grade 3 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grades 1 to 4 | 75 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycemia, Grade 4 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypokalemia, Grades 1 to 4 | 7 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypokalemia, Grades 2 to 4 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grades 2 to 4 | 49 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypokalemia, Grades 3 to 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALP, Grade 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypokalemia, Grade 1 | 6 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grades 2 to 4 | 52 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypokalemia, Grade 2 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | AST, Grades 1 to 4 | 79 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypokalemia, Grade 3 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypocalcaemia, Grade 1 | 10 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypokalemia, Grade 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | AST, Grades 2 to 4 | 31 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyponatremia, Grades 1 to 4 | 28 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grades 3 to 4 | 36 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyponatremia, Grades 3 to 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | AST, Grades 3 to 4 | 13 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyponatremia, Grade 1 | 28 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lactate Dehydrogenase, Grades 2 to 4 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyponatremia, Grade 2 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | AST, Grade 1 | 48 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyponatremia, Grade 3 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lactate Dehydrogenase, Grades 3 to 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyponatremia, Grade 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | AST, Grade 2 | 18 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | LDL Cholesterol, Grades 1 to 4 | 35 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grade 2 | 16 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | LDL Cholesterol, Grades 2 to 4 | 14 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | AST, Grade 3 | 9 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | LDL Cholesterol, Grades 3 to 4 | 4 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lactate Dehydrogenase, Grade 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | AST, Grade 4 | 4 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grade 1 | 31 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grade 3 | 21 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grade 2 | 31 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Bilirubin, Grades 1 to 4 | 51 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grade 3 | 10 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyponatremia, Grades 2 to 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grade 4 | 8 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Bilirubin, Grades 2 to 4 | 17 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Phosphate, Grades 1 to 4 | 68 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grade 4 | 15 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Phosphate, Grades 2 to 4 | 47 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Bilirubin, Grades 3 to 4 | 4 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Phosphate, Grades 3 to 4 | 6 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Bilirubin, Grade 1 | 34 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Phosphate, Grade 1 | 21 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lactate Dehydrogenase, Grade 1 | 4 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Phosphate, Grade 2 | 41 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Bilirubin, Grade 2 | 13 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Phosphate, Grade 3 | 6 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Creatinine, Grades 1 to 4 | 31 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Phosphate, Grade 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Creatinine, Grade 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Bilirubin, Grade 3 | 4 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Direct Bilirubin, Grade 2 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Direct Bilirubin, Grades 1 to 4 | 13 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | LDL Cholesterol, Grade 1 | 21 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Triglycerides, Grades 1 to 4 | 62 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Bilirubin, Grade 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Triglycerides, Grades 2 to 4 | 14 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Creatinine, Grades 2 to 4 | 3 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Triglycerides, Grades 3 to 4 | 3 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CO2, Grades 1 to 4 | 116 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Triglycerides, Grade 1 | 48 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grades 1 to 4 | 80 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Triglycerides, Grade 2 | 11 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CO2, Grades 2 to 4 | 9 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Triglycerides, Grade 3 | 2 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | LDL Cholesterol, Grade 2 | 10 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Triglycerides, Grade 4 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Direct Bilirubin, Grade 3 | 13 Participants |
Secondary
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144
Blood samples were collected up to Week 144 for assessment of hemoglobin, leukocytes, neutrophils and platelets. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the listed hematology parameters have been presented.
Time frame: Up to Week 144
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Neutrophils, Grade 2 | 12 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Leukocytes, Grade 1 | 12 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Neutrophils, Grade 3 | 5 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Hemoglobin, Grade 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Neutrophils, Grade 4 | 2 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Leukocytes, Grade 2 | 4 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Platelets, Grades 1 to 4 | 14 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Neutrophils, Grades 1 to 4 | 25 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Platelets, Grades 2 to 4 | 8 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Leukocytes, Grade 3 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Platelets, Grades 3 to 4 | 1 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Leukocytes, Grades 1 to 4 | 16 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Platelets, Grade 1 | 6 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Platelets, Grade 2 | 7 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Leukocytes, Grades 2 to 4 | 4 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Platelets, Grade 3 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Neutrophils, Grades 2 to 4 | 19 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Platelets, Grade 4 | 1 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Hemoglobin, Grade 3 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Hemoglobin, Grades 1 to 4 | 9 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Neutrophils, Grades 3 to 4 | 7 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Hemoglobin, Grades 2 to 4 | 1 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Leukocytes, Grades 3 to 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Hemoglobin, Grades 3 to 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Neutrophils, Grade 1 | 6 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Hemoglobin, Grade 1 | 8 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Leukocytes, Grade 4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Hemoglobin, Grade 2 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Hemoglobin, Grades 1 to 4 | 7 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Hemoglobin, Grade 3 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Hemoglobin, Grade 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Leukocytes, Grades 1 to 4 | 3 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Leukocytes, Grades 2 to 4 | 2 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Leukocytes, Grades 3 to 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Leukocytes, Grade 1 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Leukocytes, Grade 2 | 2 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Leukocytes, Grade 3 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Leukocytes, Grade 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Neutrophils, Grades 1 to 4 | 18 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Neutrophils, Grades 2 to 4 | 11 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Neutrophils, Grades 3 to 4 | 6 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Neutrophils, Grade 1 | 7 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Neutrophils, Grade 2 | 5 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Neutrophils, Grade 3 | 5 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Neutrophils, Grade 4 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Platelets, Grades 1 to 4 | 11 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Platelets, Grades 2 to 4 | 4 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Platelets, Grades 3 to 4 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Platelets, Grade 1 | 7 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Platelets, Grade 2 | 3 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Platelets, Grade 3 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Platelets, Grade 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Hemoglobin, Grade 2 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Hemoglobin, Grades 2 to 4 | 1 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Hemoglobin, Grades 3 to 4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Hemoglobin, Grade 1 | 6 Participants |
Secondary
Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144
Number of participants, who met confirmed virologic withdrawal (CVW) criteria, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI) and/or Nucleoside reverse transcriptase inhibitor (NRTI) was summarized. The Viral Genotypic Population comprised of all participants in the ITT-E population who have available on-treatment genotypic resistance data.
Time frame: Up to Week 144
Population: Viral Genotypic Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144 | INSTI Mutations | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144 | Major mutations of NRTI | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144 | INSTI Mutations | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144 | Major mutations of NRTI | 0 Participants |
Secondary
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144
Number of participants, who meet CVW criteria, with treatment emergent phenotypic resistance to INSTI and/or NRTI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The Viral Phenotypic Population comprised of all participants in the ITT-E population who have available on-treatment phenotypic resistance data.
Time frame: Up to Week 144
Population: Viral Phenotypic Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, EGV, Sensitive, n=5,4 | 5 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, EGV, Resistant, n=5,4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, RAL, Sensitive, n=5,4 | 5 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, RAL, Resistant, n=5,4 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, 3TC, Sensitive, n=5,5 | 5 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, 3TC, Resistant, n=5,5 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, ABC, Sensitive, n=5,5 | 5 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, ABC, Resistant, n=5,5 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, AZT, Sensitive, n=5,5 | 5 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, AZT, Resistant, n=5,5 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, D4T, Sensitive, n=5,5 | 5 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, D4T, Resistant, n=5,5 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, DDI, Sensitive, n=5,5 | 5 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, DDI, Resistant, n=5,5 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, FTC, Sensitive, n=5,5 | 5 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, FTC, Resistant, n=5,5 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, TDF, Sensitive, n=5,5 | 5 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, TDF, Resistant, n=5,5 | 0 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, DTG, Sensitive, n=,5,4 | 5 Participants |
| DTG + 3TC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, DTG, Resistant, n=5,4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, EGV, Sensitive, n=5,4 | 4 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, D4T, Resistant, n=5,5 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, EGV, Resistant, n=5,4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, TDF, Resistant, n=5,5 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, RAL, Sensitive, n=5,4 | 4 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, AZT, Sensitive, n=5,5 | 5 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, RAL, Resistant, n=5,4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, DDI, Resistant, n=5,5 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, 3TC, Sensitive, n=5,5 | 5 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, DDI, Sensitive, n=5,5 | 5 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, 3TC, Resistant, n=5,5 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, FTC, Sensitive, n=5,5 | 5 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, ABC, Sensitive, n=5,5 | 5 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, DTG, Resistant, n=5,4 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, ABC, Resistant, n=5,5 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, FTC, Resistant, n=5,5 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, DTG, Sensitive, n=,5,4 | 4 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, AZT, Resistant, n=5,5 | 0 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, TDF, Sensitive, n=5,5 | 5 Participants |
| DTG + TDF/FTC-Double Blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, D4T, Sensitive, n=5,5 | 5 Participants |
Secondary
Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48
Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by (\[post-dose visit value minus Baseline value\] divided by Baseline value).
Time frame: Baseline (Day 1) and at Weeks 24, 48
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48 | Total/HDL Cholesterol Ratio, Week 24, n=294, 297 | -4.0 Percentage change | Standard Deviation 19.08 |
| DTG + 3TC-Double Blind Phase | Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48 | Total/HDL Cholesterol Ratio, Week 48, n=280, 289 | -0.2 Percentage change | Standard Deviation 31.1 |
| DTG + TDF/FTC-Double Blind Phase | Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48 | Total/HDL Cholesterol Ratio, Week 24, n=294, 297 | -4.6 Percentage change | Standard Deviation 27.52 |
| DTG + TDF/FTC-Double Blind Phase | Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48 | Total/HDL Cholesterol Ratio, Week 48, n=280, 289 | -4.4 Percentage change | Standard Deviation 16.96 |
Secondary
Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48
Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value is defined as the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by (\[post-dose visit value minus Baseline value\] divided by Baseline value).
Time frame: Baseline (Day 1) and at Weeks 24, 48
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | Serum or Plasma Cholesterol, Week 24, n=294, 297 | 9.4 Percentage change | Standard Deviation 17.44 |
| DTG + 3TC-Double Blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | Serum or Plasma Cholesterol, Week 48, n=280, 289 | 10.5 Percentage change | Standard Deviation 18.89 |
| DTG + 3TC-Double Blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | HDL Cholesterol, Direct, Week 24, n=294, 297 | 16.4 Percentage change | Standard Deviation 22.58 |
| DTG + 3TC-Double Blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | HDL Cholesterol, Direct, Week 48, n=280, 289 | 15.0 Percentage change | Standard Deviation 25.07 |
| DTG + 3TC-Double Blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | LDL Cholesterol, Week 24, n=294, 297 | 12.4 Percentage change | Standard Deviation 45.05 |
| DTG + 3TC-Double Blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | LDL Cholesterol, Week 48, n=280, 289 | 14.8 Percentage change | Standard Deviation 48.74 |
| DTG + 3TC-Double Blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | Triglycerides ,Week 24, n=294, 297 | 8.5 Percentage change | Standard Deviation 46.57 |
| DTG + 3TC-Double Blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | Triglycerides , Week 48, n=280, 289 | 12.8 Percentage change | Standard Deviation 68.99 |
| DTG + TDF/FTC-Double Blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | Triglycerides , Week 48, n=280, 289 | 4.4 Percentage change | Standard Deviation 70.43 |
| DTG + TDF/FTC-Double Blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | Serum or Plasma Cholesterol, Week 24, n=294, 297 | -4.7 Percentage change | Standard Deviation 16.12 |
| DTG + TDF/FTC-Double Blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | LDL Cholesterol, Week 24, n=294, 297 | -8.1 Percentage change | Standard Deviation 23.7 |
| DTG + TDF/FTC-Double Blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | Serum or Plasma Cholesterol, Week 48, n=280, 289 | -2.4 Percentage change | Standard Deviation 17.14 |
| DTG + TDF/FTC-Double Blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | Triglycerides ,Week 24, n=294, 297 | 4.3 Percentage change | Standard Deviation 72.35 |
| DTG + TDF/FTC-Double Blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | HDL Cholesterol, Direct, Week 24, n=294, 297 | 3.4 Percentage change | Standard Deviation 21.55 |
| DTG + TDF/FTC-Double Blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | LDL Cholesterol, Week 48, n=280, 289 | -4.0 Percentage change | Standard Deviation 24.06 |
| DTG + TDF/FTC-Double Blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | HDL Cholesterol, Direct, Week 48, n=280, 289 | 5.0 Percentage change | Standard Deviation 33.04 |
Secondary
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (\<35, 35 to \<50, \>=50 years); gender (males and females), Baseline CD4+ cell count (\<=200 cells/mm\^3, \>200 cells/mm\^3), Baseline HIV-1 RNA (\<=100000, \>100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded to the nearest whole digit.
Time frame: Week 144
Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Female, n=59, 52 | 71 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Baseline plasma HIV-1 RNA, <=100000,n=282,282 | 79 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Baseline CD4+ cell count, <=200,n=31, 29 | 58 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Baseline plasma HIV-1 RNA, >100000,n=74, 76 | 78 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Male, n=297,306, | 80 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Race, White, n=244,247 | 82 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Age, 35 to <50,n=116, 107 | 81 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Race, African American/African H., n=39,36 | 69 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Age, <35,n= 211, 205 | 77 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Race, Asian, n=37, 42 | 73 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Baseline CD4+ cell count, >200,n=325,329 | 81 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Race, Other, n=36, 33 | 78 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Age, >=50, n=29,46 | 83 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Race, Other, n=36, 33 | 79 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Age, <35,n= 211, 205 | 83 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Baseline CD4+ cell count, <=200,n=31, 29 | 83 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Female, n=59, 52 | 85 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Male, n=297,306, | 82 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Age, 35 to <50,n=116, 107 | 83 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Age, >=50, n=29,46 | 78 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Baseline plasma HIV-1 RNA, <=100000,n=282,282 | 82 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Baseline plasma HIV-1 RNA, >100000,n=74, 76 | 87 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Race, White, n=244,247 | 85 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Race, African American/African H., n=39,36 | 72 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Race, Asian, n=37, 42 | 81 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 | Baseline CD4+ cell count, >200,n=325,329 | 83 Percentage of participants |
Secondary
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (\<35, 35 to \<50, \>=50 years); gender (males and females), Baseline CD4+ cell count (\<=200, \>200), Baseline HIV-1 RNA (\<=100000, \>100000) and Race (White, African American/African H., Asian, Other). Percentage values are rounded to the nearest whole digit.
Time frame: Week 24
Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Race, African American/African H., n=39, 36 | 92 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Female, n=59, 52 | 93 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Male, n=297, 306 | 92 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Age, <35,n= 211, 205 | 93 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Age, 35 to <50,n=116, 107 | 91 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Age, >=50, n=29, 46 | 93 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Baseline plasma HIV-1 RNA, <=100000,n=282,282 | 93 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Baseline plasma HIV-1 RNA, >100000,n=74, 76 | 92 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Race, White, n=244,247 | 93 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Race, Asian, n=37, 42 | 89 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Race, Other, n=36, 33 | 94 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Baseline CD4+ cell count, <=200,n=31,29 | 90 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Baseline CD4+ cell count, >200,n=325,329 | 93 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Baseline CD4+ cell count, <=200,n=31,29 | 86 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Baseline CD4+ cell count, >200,n=325,329 | 94 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Baseline plasma HIV-1 RNA, >100000,n=74, 76 | 87 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Race, Other, n=36, 33 | 94 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Male, n=297, 306 | 92 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Race, White, n=244,247 | 95 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Age, <35,n= 211, 205 | 95 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Race, African American/African H., n=39, 36 | 81 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Age, 35 to <50,n=116, 107 | 93 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Female, n=59, 52 | 96 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Age, >=50, n=29, 46 | 85 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Race, Asian, n=37, 42 | 93 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 | Baseline plasma HIV-1 RNA, <=100000,n=282,282 | 95 Percentage of participants |
Secondary
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (\<35, 35 to \<50, \>=50 years); gender (males and females), Baseline CD4+ cell count (\<=200, \>200), Baseline HIV-1 RNA (\<=100000, \>100000) and Race (White, African American/African H., Asian, Other). Percentage values are rounded to the nearest whole digit.
Time frame: Week 48
Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Female, n=59, 52 | 88 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Baseline plasma HIV-1 RNA, <=100000,n=282,282 | 90 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Age, <35,n= 211, 205 | 92 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Baseline plasma HIV-1 RNA, >100000,n=74, 76 | 88 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Baseline CD4+ cell count, >200,n=325,329 | 91 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Race, White, n=244,247 | 90 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Age, 35 to <50,n=116, 107 | 86 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Race, African American/African H., n=39, 36 | 87 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Race, Asian, n=37, 42 | 92 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Male, n=297, 306 | 90 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Race, Other, n=36, 33 | 89 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Age, >=50, n=29, 46 | 90 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Baseline CD4+ cell count, <=200,n=31,29 | 81 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Race, African American/African H., n=39, 36 | 81 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Baseline CD4+ cell count, <=200,n=31,29 | 90 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Baseline CD4+ cell count, >200,n=325,329 | 93 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Female, n=59, 52 | 94 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Male, n=297, 306 | 92 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Age, <35,n= 211, 205 | 93 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Age, 35 to <50,n=116, 107 | 94 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Age, >=50, n=29, 46 | 87 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Baseline plasma HIV-1 RNA, <=100000,n=282,282 | 93 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Baseline plasma HIV-1 RNA, >100000,n=74, 76 | 91 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Race, White, n=244,247 | 94 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Race, Asian, n=37, 42 | 98 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 | Race, Other, n=36, 33 | 94 Percentage of participants |
Secondary
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (\<35, 35 to \<50, \>=50 years); gender (males and females), Baseline CD4+ cell count (\<=200 cells/mm\^3, \>200 cells/mm\^3), Baseline HIV-1 RNA (\<=100000, \>100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded to the nearest whole digit.
Time frame: Week 96
Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Baseline CD4+ cell count, <=200,n=31, 29 | 65 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Baseline CD4+ cell count, >200,n=325,329 | 86 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Age, >=50, n=29,46 | 86 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Female, n=59, 52 | 83 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Male, n=297,306, | 85 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Age, <35,n= 211, 205 | 84 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Age, 35 to <50,n=116, 107 | 84 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Baseline plasma HIV-1 RNA, <=100000,n=282,282 | 85 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Baseline plasma HIV-1 RNA, >100000,n=74, 76 | 81 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Race, White, n=244,247 | 86 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Race, African American/African H., n=39,36 | 79 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Race, Asian, n=37, 42 | 78 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Race, Other, n=36, 33 | 86 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Race, White, n=244,247 | 90 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Baseline CD4+ cell count, <=200,n=31, 29 | 90 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Race, Asian, n=37, 42 | 90 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Baseline CD4+ cell count, >200,n=325,329 | 89 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Age, 35 to <50,n=116, 107 | 89 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Baseline plasma HIV-1 RNA, <=100000,n=282,282 | 90 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Age, >=50, n=29,46 | 87 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Race, African American/African H., n=39,36 | 81 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Female, n=59, 52 | 88 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Baseline plasma HIV-1 RNA, >100000,n=74, 76 | 88 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Male, n=297,306, | 90 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Race, Other, n=36, 33 | 91 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 | Age, <35,n= 211, 205 | 90 Percentage of participants |
Secondary
Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144
Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 144 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 144 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded to the nearest whole digit.
Time frame: Week 144
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTG + 3TC-Double Blind Phase | Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144 | 5 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144 | 4 Percentage of participants |
p-value: 0.58795% CI: [-2.4, 4.3]Fisher Exact
Secondary
Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96
Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 96 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 96 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded to the nearest whole digit.
Time frame: Week 96
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTG + 3TC-Double Blind Phase | Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96 | 5 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96 | 4 Percentage of participants |
p-value: 0.56295% CI: [-2.1, 4.1]Fisher Exact
Secondary
Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48
Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Weeks 24 and 48 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 48 or those who had Baseline lipids-lowering agents are not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded to the nearest whole digit.
Time frame: Weeks 24 and Week 48
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48 | Week 24, n=309, 316 | 4 Percentage of participants |
| DTG + 3TC-Double Blind Phase | Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48 | Week 48, n=318, 320 | 4 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48 | Week 48, n=318, 320 | 3 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48 | Week 24, n=309, 316 | 2 Percentage of participants |
p-value: 0.15795% CI: [-0.6, 4.6]Fisher Exact
p-value: 0.41495% CI: [-1.7, 4.2]Fisher Exact
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144
Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded to the nearest whole digit.
Time frame: Week 144
Population: ITT-E Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTG + 3TC-Double Blind Phase | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144 | 79 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144 | 83 Percentage of participants |
95% CI: [-9.4, 2.1]
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24
Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel weights. Percentage values are rounded to the nearest whole digit.
Time frame: Week 24
Population: ITT-E Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTG + 3TC-Double Blind Phase | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24 | 92 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24 | 93 Percentage of participants |
95% CI: [-4.2, 3.4]
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96
Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel weights. Percentage values are rounded to the nearest whole digit.
Time frame: Week 96
Population: ITT-E Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTG + 3TC-Double Blind Phase | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96 | 84 Percentage of participants |
| DTG + TDF/FTC-Double Blind Phase | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96 | 89 Percentage of participants |
95% CI: [-9.8, 0]
Secondary
Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Statistical analysis of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. Estimated ratio of geometric means (each visit over Baseline) and 95% confidence interval (CI) have been presented.
Time frame: Baseline (Day 1) and Week 144
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144 | Urine Albumin/Creatinine , Week 144, n=207, 212 | 1.050 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144 | Urine B2M/Urine Creatinine , Week 144, n=100, 102 | 0.751 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144 | Urine Phosphate, Week 144, n=274, 294 | 1.040 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144 | Urine RBP 4/Urine Creatinine, Week 144, n=276, 292 | 1.648 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144 | Urine Protein/Creatinine , Week 144, n=225,232 | 0.988 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144 | Urine Phosphate, Week 144, n=274, 294 | 0.955 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144 | Urine Albumin/Creatinine , Week 144, n=207, 212 | 1.146 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144 | Urine Protein/Creatinine , Week 144, n=225,232 | 1.210 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144 | Urine B2M/Urine Creatinine , Week 144, n=100, 102 | 1.518 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144 | Urine RBP 4/Urine Creatinine, Week 144, n=276, 292 | 2.425 Ratio |
p-value: 0.20595% CI: [0.799, 1.05]Mixed Model Repeated Measures
p-value: <0.00195% CI: [0.406, 0.603]Mixed Model Repeated Measures
p-value: 0.1695% CI: [0.967, 1.226]Mixed Model Repeated Measures
p-value: <0.00195% CI: [0.753, 0.885]Mixed Model Repeated Measures
p-value: <0.00195% CI: [0.607, 0.76]Mixed Model Repeated Measures
Secondary
Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Statistical analysis of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. Estimated ratio of geometric means (each visit over Baseline) and 95% confidence interval (CI) have been presented.
Time frame: Baseline (Day 1) and Week 96
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96 | Urine Albumin/Creatinine, Week 96, n=222, 243 | 0.924 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96 | Urine B2M/Urine Creatinine , Week 96, n=107, 104 | 0.794 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96 | Urine Phosphate, Week 96, n=292, 316 | 1.113 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96 | Urine RBP 4/Urine Creatinine, Week 96, n=289, 311 | 1.310 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96 | Urine Protein/Creatinine, Week 96, n=238, 258 | 0.868 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96 | Urine Phosphate, Week 96, n=292, 316 | 1.066 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96 | Urine Albumin/Creatinine, Week 96, n=222, 243 | 1.101 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96 | Urine Protein/Creatinine, Week 96, n=238, 258 | 1.053 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96 | Urine B2M/Urine Creatinine , Week 96, n=107, 104 | 1.441 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96 | Urine RBP 4/Urine Creatinine, Week 96, n=289, 311 | 1.771 Ratio |
p-value: 0.00695% CI: [0.742, 0.95]Mixed Model Repeated Measures
p-value: <0.00195% CI: [0.445, 0.682]Mixed Model Repeated Measures
p-value: 0.46795% CI: [0.928, 1.175]Mixed Model Repeated Measures
p-value: <0.00195% CI: [0.764, 0.889]Mixed Model Repeated Measures
p-value: <0.00195% CI: [0.651, 0.84]Mixed Model Repeated Measures
Secondary
Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Statistical analysis of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. Estimated ratio of geometric means (each visit over Baseline) and 95% confidence interval (CI) have been presented.
Time frame: Baseline (Day 1) and at Weeks 24, 48
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Serum B2M, Week 48, n=324, 332 | 0.806 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine Phosphate, Week 48, n=316, 330 | 1.061 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine Protein/Creatinine, Week 24, n=269, 265 | 0.850 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine Albumin/Creatinine , Week 48, n=237, 244 | 0.934 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine Protein/Creatinine, Week 48, n=252, 269 | 0.879 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine B2M, Week 48, n=119, 103 | 0.900 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine RBP 4, Week 24, n=332, 330 | 0.934 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine B2M/Urine Creatinine, Week 24, n=121, 95 | 0.852 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine RBP 4, Week 48, n=318, 328 | 1.115 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine B2M, Week 24, n=121, 95 | 0.887 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine RBP 4/Urine Creatinine, Week 24, n=329, 330 | 0.919 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine B2M/Urine Creatinine, Week 48, n=114, 100 | 0.888 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine RBP 4/Urine Creatinine, Week 48, n=304, 318 | 1.147 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine Albumin/Creatinine, Week 24, n=254, 252 | 1.014 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine Phosphate, Week 24, n=330, 332 | 1.115 Ratio |
| DTG + 3TC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Serum B2M, Week 24, n=338, 335 | 0.798 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Serum B2M, Week 48, n=324, 332 | 0.892 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Serum B2M, Week 24, n=338, 335 | 0.872 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine B2M, Week 24, n=121, 95 | 1.351 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine B2M, Week 48, n=119, 103 | 1.338 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine Albumin/Creatinine, Week 24, n=254, 252 | 1.050 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine Albumin/Creatinine , Week 48, n=237, 244 | 1.048 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine B2M/Urine Creatinine, Week 24, n=121, 95 | 1.331 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine B2M/Urine Creatinine, Week 48, n=114, 100 | 1.278 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine Phosphate, Week 24, n=330, 332 | 1.012 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine Protein/Creatinine, Week 24, n=269, 265 | 1.016 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine Protein/Creatinine, Week 48, n=252, 269 | 1.061 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine RBP 4, Week 24, n=332, 330 | 1.073 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine RBP 4, Week 48, n=318, 328 | 1.490 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine RBP 4/Urine Creatinine, Week 24, n=329, 330 | 1.110 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine RBP 4/Urine Creatinine, Week 48, n=304, 318 | 1.500 Ratio |
| DTG + TDF/FTC-Double Blind Phase | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 | Urine Phosphate, Week 48, n=316, 330 | 1.075 Ratio |
p-value: <0.00195% CI: [0.887, 0.943]Mixed Model Repeated Measures
p-value: <0.00195% CI: [0.88, 0.929]Mixed Model Repeated Measures
p-value: 0.00595% CI: [0.491, 0.877]Mixed Model Repeated Measures
p-value: <0.00195% CI: [0.551, 0.821]Mixed Model Repeated Measures
p-value: 0.57595% CI: [0.853, 1.092]Mixed Model Repeated Measures
p-value: 0.05195% CI: [0.793, 1.001]Mixed Model Repeated Measures
p-value: <0.00195% CI: [0.493, 0.831]Mixed Model Repeated Measures
p-value: <0.00195% CI: [0.576, 0.839]Mixed Model Repeated Measures
p-value: 0.09995% CI: [0.982, 1.237]Mixed Model Repeated Measures
p-value: 0.81695% CI: [0.886, 1.1]Mixed Model Repeated Measures
p-value: <0.00195% CI: [0.774, 0.904]Mixed Model Repeated Measures
p-value: <0.00195% CI: [0.773, 0.888]Mixed Model Repeated Measures
p-value: 0.08795% CI: [0.743, 1.02]Mixed Model Repeated Measures
p-value: <0.00195% CI: [0.644, 0.87]Mixed Model Repeated Measures
p-value: 0.00595% CI: [0.727, 0.944]Mixed Model Repeated Measures
p-value: <0.00195% CI: [0.677, 0.864]Mixed Model Repeated Measures
Secondary
Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144
Time of viral suppression is defined as the first viral load value \<50 c/mL. Nonparametric Kaplan-Meier method was performed. Participants who withdrew for any reason without being suppressed were censored at date of withdrawal. Participants who have not been withdrawn and have not had viral suppression at time of the analysis were censored at last viral load date. Confidence Interval (CI) was estimated using the Brookmeyer-Crowley method.
Time frame: Up to Week 144
Population: ITT-E Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DTG + 3TC-Double Blind Phase | Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144 | 29.0 Days |
| DTG + TDF/FTC-Double Blind Phase | Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144 | 29.0 Days |
p-value: 0.65895% CI: [0.86, 1.16]Generalized Wilcoxon procedure