Infection, Human Immunodeficiency Virus, HIV Infections
Conditions
Keywords
tolerability, HIV 1, efficacy, treatment naïve, two-drug regimen, safety, non inferiority
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 disoproxil fumarate \[TDF\]/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 + 3TC regimen to that of DTG + 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
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 * Participant 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 * Participants 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 C 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 off. |
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 CMH weights. Percentage values are rounded off. |
| 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 off. |
| 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+ cells. Analysis was performed 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 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+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted least 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 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. Change from Baseline was defined as value at the indicated time point 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 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. Change from Baseline was defined as value at the indicated time point 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. Participants may have more than one indicators of clinical disease progression including death, hence they may contribute to data in more than one categories. |
| 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 met 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 were interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drugs (DTG, 3TC, Abacavir \[ABC\], elvitegravir \[EGV\], raltegravir \[RAL\], zidovudine \[AZT\], stavudine \[D4T\], didanosine \[DDI\]), emtricitabine \[FTC\], tenofovir disiproxil fumarate \[TDF\]). Partially sensitive and resistant cells 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 With Any Adverse Event (AE) and Serious AE (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 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. AEs were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (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 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. 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 platelet count. 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. |
| Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48 | Baseline and at Weeks 24, 48 | Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C and Serum RBP. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point 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. |
| 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), 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 Weeks 24, 48 and 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. |
| 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. |
| Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96 | Baseline and at Week 96 | Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point 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 Cystatin C at Week 144 | Baseline and at Week 144 | Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point 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 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. Change from Baseline was defined as value at indicated time point 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 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. Change from Baseline was defined as value at indicated time point 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 and at Weeks 24, 48 | Blood samples were collected to perform evaluation of renal 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. Change from Baseline was defined as value at the indicated time point 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 CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96 | Baseline 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. Change from Baseline was defined as value at the indicated time point 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 CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144 | Baseline 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. Change from Baseline was defined as value at the indicated time point 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 and at Weeks 24, 48 | Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point 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 Week 96 | Baseline and at Week 96 | Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point 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 has been presented. |
| Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144 | Baseline and at Week 144 | Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point 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 has been presented. |
| 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 and Weeks 24, 48 | Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers: 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 was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Geometric mean ratio and 95% CI of geometric mean ratio have been presented. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor. |
| 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 and Week 96 | Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers: Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor. |
| 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 and at Week 144 | Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers: Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor. |
| 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. 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. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. |
| 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, Serum PINP and Serum Type CTX-1. Adjusted mean is the estimated mean change from Baseline 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. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated 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-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, Serum PINP and Serum Type CTX-1. Adjusted mean is the estimated mean change from Baseline 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. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. |
| Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48 | Baseline and at Weeks 24, 48 | Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. 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. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. |
| Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96 | Baseline and at Week 96 | Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. 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. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. |
| Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144 | Baseline and at Week 144 | Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. 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. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. |
| Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | Baseline 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. |
| 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. |
| 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). Lipid last observation carried forwarded (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. Participants on lipid-lowering agents at Baseline were excluded. |
| 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 is the latest pre-dose assessment (Day 1). 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 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 is the latest pre-dose assessment (Day 1). 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 of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48 | Weeks 24 and 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 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-off. |
| 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-off. |
| 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-off. |
| 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 cells/mm\^3, \>200 cells/mm\^3 for group-1), Baseline HIV-1 RNA (\<=100000, \>100000 c/mL) and Race (White, African American/African heritage (H.), Asian other). Percentage values are rounded-off. |
| 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 cells/mm\^3, \>200 cells/mm\^3 for group-1), Baseline HIV-1 RNA (\<=100000, \>100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded-off. |
| 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-off. |
| 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-off. |
| 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 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. |
| 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 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 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 CMH weights. Percentage values are rounded off. |
| 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 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 European Quality of Life [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. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment 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. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. |
| 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. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. |
| 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 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 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 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 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 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, Peru, Poland, Portugal, Romania, Russia, Spain, Switzerland, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
This study is a Phase 3, randomized, double-blind, parallel group, non-inferiority study. The study consisted of double-blind phase, open-label phase and continuation phase.
Pre-assignment details
Total of 722 participants were enrolled and randomized; however only 719 participants (3 participants were never dosed following randomization) were dosed in to the study to receive either dolutegravir plus lamivudine (DTG+3TC) or dolutegravir plus tenofovir/emtricitabine (DTG+TDF/FTC) 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 DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase. | 360 |
| DTG + TDF/FTC - Double-blind Phase Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase. | 359 |
| Total | 719 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Continuation Phase(Week 148 to Week 280) | Lost to Follow-up | 0 | 0 | 0 | 0 | 2 |
| Continuation Phase(Week 148 to Week 280) | Physician Decision | 0 | 0 | 0 | 0 | 5 |
| 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 | 5 |
| Double-blind Phase (Day1 to Week 96) | Adverse Event | 10 | 6 | 0 | 0 | 0 |
| Double-blind Phase (Day1 to Week 96) | Lack of Efficacy | 5 | 2 | 0 | 0 | 0 |
| Double-blind Phase (Day1 to Week 96) | Lost to Follow-up | 9 | 7 | 0 | 0 | 0 |
| Double-blind Phase (Day1 to Week 96) | Physician Decision | 3 | 3 | 0 | 0 | 0 |
| Double-blind Phase (Day1 to Week 96) | Protocol Deviation | 5 | 3 | 0 | 0 | 0 |
| Double-blind Phase (Day1 to Week 96) | Protocol specific withdrawal criteria | 0 | 2 | 0 | 0 | 0 |
| Double-blind Phase (Day1 to Week 96) | Randomized, but did not receive treatment | 0 | 3 | 0 | 0 | 0 |
| Double-blind Phase (Day1 to Week 96) | Withdrawal by Subject | 9 | 9 | 0 | 0 | 0 |
| Open-label Phase (Week 96 to Week 148) | Adverse Event | 0 | 0 | 1 | 6 | 0 |
| Open-label Phase (Week 96 to Week 148) | Lack of Efficacy | 0 | 0 | 2 | 0 | 0 |
| Open-label Phase (Week 96 to Week 148) | Lost to Follow-up | 0 | 0 | 4 | 7 | 0 |
| Open-label Phase (Week 96 to Week 148) | Physician Decision | 0 | 0 | 1 | 3 | 0 |
| Open-label Phase (Week 96 to Week 148) | Protocol Deviation | 0 | 0 | 2 | 2 | 0 |
| Open-label Phase (Week 96 to Week 148) | Protocol-Specified Withdrawal Criteria | 0 | 0 | 1 | 0 | 0 |
| Open-label Phase (Week 96 to Week 148) | Withdrawal by Subject | 0 | 0 | 7 | 9 | 0 |
Baseline characteristics
| Characteristic | DTG + TDF/FTC - Double-blind Phase | Total | DTG + 3TC - Double-blind Phase |
|---|---|---|---|
| Age, Continuous | 34.4 Years STANDARD_DEVIATION 10.35 | 34.5 Years STANDARD_DEVIATION 10.53 | 34.6 Years STANDARD_DEVIATION 10.72 |
| Race/Ethnicity, Customized American (Am) Indian or Alaska (Al.) native | 29 Participants | 50 Participants | 21 Participants |
| Race/Ethnicity, Customized Asian-Central/South Asian heritage (H.) | 3 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian - East Asian H. | 26 Participants | 54 Participants | 28 Participants |
| Race/Ethnicity, Customized Asian - South East Asian H. | 1 Participants | 7 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African Am | 35 Participants | 86 Participants | 51 Participants |
| Race/Ethnicity, Customized Multiple | 12 Participants | 26 Participants | 14 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White (Wt)-Arabic/North African H. | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Wt-Wt/Caucasian (Ca.)/European (Eu.) H. | 249 Participants | 486 Participants | 237 Participants |
| Sex: Female, Male Female | 46 Participants | 100 Participants | 54 Participants |
| Sex: Female, Male Male | 313 Participants | 619 Participants | 306 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 360 | 1 / 359 | 0 / 252 |
| other Total, other adverse events | 273 / 360 | 276 / 359 | 45 / 252 |
| serious Total, serious adverse events | 39 / 360 | 47 / 359 | 9 / 252 |
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 off.
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 | 93 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 | 94 Percentage of participants |
95% CI: [-4.3, 2.9]
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 | 763.8 Cells/mm^3 | Standard Deviation 266.61 |
| DTG + TDF/FTC - Double-blind Phase | CD4+ Cell Counts at Week 144 | 770.4 Cells/mm^3 | Standard Deviation 332.65 |
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 | 734.9 Cells/mm^3 | Standard Deviation 270.82 |
| DTG + TDF/FTC - Double-blind Phase | CD4+ Cell Counts at Week 96 | 739.9 Cells/mm^3 | Standard Deviation 299.8 |
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+ cells. Analysis was performed 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=349,345 | 650.4 Cells/mm^3 | Standard Deviation 257.02 |
| DTG + 3TC - Double-blind Phase | CD4+ Cell Counts at Weeks 24 and 48 | Week 48, n=337,340 | 688.1 Cells/mm^3 | Standard Deviation 266.39 |
| DTG + TDF/FTC - Double-blind Phase | CD4+ Cell Counts at Weeks 24 and 48 | Week 24, n=349,345 | 633.0 Cells/mm^3 | Standard Deviation 287.37 |
| DTG + TDF/FTC - Double-blind Phase | CD4+ Cell Counts at Weeks 24 and 48 | Week 48, n=337,340 | 689.8 Cells/mm^3 | Standard Deviation 308.49 |
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. 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. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value.
Time frame: Baseline 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 | 1.1 Nanomoles per Liter (nmol/L) | Standard Error 1.2 |
| DTG + TDF/FTC - Double-blind Phase | Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144 | 1.4 Nanomoles per Liter (nmol/L) | Standard Error 1.22 |
p-value: 0.88795% CI: [-3.6, 3.1]MMRM
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. 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. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value.
Time frame: Baseline 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 | -1.7 Nanomoles per Liter (nmol/L) | Standard Error 1.01 |
| DTG + TDF/FTC - Double-blind Phase | Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96 | 1.3 Nanomoles per Liter (nmol/L) | Standard Error 1.09 |
p-value: 0.04895% CI: [-5.9, 0]MMRM
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. 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. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value.
Time frame: Baseline 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 (LEAST_SQUARES_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=346, 344 | 11.2 Nanomoles per Liter (nmol/L) | Standard Error 1.08 |
| DTG + 3TC - Double-blind Phase | Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48 | Serum Vitamin D, Week 48, n=336, 335 | 0.3 Nanomoles per Liter (nmol/L) | Standard Error 0.92 |
| 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=346, 344 | 15.4 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=336, 335 | 0.4 Nanomoles per Liter (nmol/L) | Standard Error 1.01 |
p-value: 0.01595% CI: [-7.5, -0.8]MMRM
p-value: 0.9695% CI: [-2.8, 2.6]MMRM
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, Serum PINP and Serum Type CTX-1. Adjusted mean is the estimated mean change from Baseline 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. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated 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 (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 | Bone-ALP, Week 144, n=302, 305 | -0.25 Micrograms per Liter (ug/L) | Standard Error 0.156 |
| 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=300, 304 | -1.02 Micrograms per Liter (ug/L) | Standard Error 0.28 |
| 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=299, 300 | -0.1 Micrograms per Liter (ug/L) | Standard Error 0.94 |
| 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=291, 298 | 0.0505 Micrograms per Liter (ug/L) | Standard Error 0.01154 |
| 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=291, 298 | 0.1868 Micrograms per Liter (ug/L) | Standard Error 0.01516 |
| 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=302, 305 | 1.88 Micrograms per Liter (ug/L) | Standard Error 0.266 |
| 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=299, 300 | 9.4 Micrograms per Liter (ug/L) | Standard Error 1.39 |
| 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=300, 304 | 2.87 Micrograms per Liter (ug/L) | Standard Error 0.412 |
p-value: <0.00195% CI: [-2.74, -1.53]MMRM
p-value: <0.00195% CI: [-4.87, -2.91]MMRM
p-value: <0.00195% CI: [-12.8, -6.2]MMRM
p-value: <0.00195% CI: [-0.1739, -0.0988]MMRM
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, Serum PINP and Serum Type CTX-1. Adjusted mean is the estimated mean change from Baseline 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. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated 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 (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=315, 326 | 0.26 Micrograms per Liter (ug/L) | Standard Error 0.188 |
| 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=315, 326 | 0.13 Micrograms per Liter (ug/L) | Standard Error 0.286 |
| 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=315, 325 | 7.0 Micrograms per Liter (ug/L) | Standard Error 1.37 |
| 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=311, 318 | 0.0604 Micrograms per Liter (ug/L) | Standard Error 0.01056 |
| 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=311, 318 | 0.1787 Micrograms per Liter (ug/L) | Standard Error 0.01403 |
| 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=315, 326 | 2.39 Micrograms per Liter (ug/L) | Standard Error 0.234 |
| 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=315, 325 | 19.5 Micrograms per Liter (ug/L) | Standard Error 1.66 |
| 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=315, 326 | 3.90 Micrograms per Liter (ug/L) | Standard Error 0.368 |
p-value: <0.00195% CI: [-2.72, -1.54]MMRM
p-value: <0.00195% CI: [-4.69, -2.85]MMRM
p-value: <0.00195% CI: [-16.8, -8.3]MMRM
p-value: <0.00195% CI: [-0.1529, -0.0838]MMRM
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. 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. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus 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 | 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=334, 337 | 1.24 Micrograms per Liter (ug/L) | Standard Error 0.198 |
| 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=345, 346 | 0.72 Micrograms per Liter (ug/L) | Standard Error 0.171 |
| 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=345, 346 | 2.13 Micrograms per Liter (ug/L) | Standard Error 0.321 |
| 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=335, 336 | 0.40 Micrograms per Liter (ug/L) | Standard Error 0.326 |
| 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=344, 346 | 1.7 Micrograms per Liter (ug/L) | Standard Error 0.95 |
| 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=335, 337 | 0.4 Micrograms per Liter (ug/L) | Standard Error 0.79 |
| 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=342, 342 | 0.1541 Micrograms per Liter (ug/L) | Standard Error 0.01247 |
| 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=332, 333 | 0.1345 Micrograms per Liter (ug/L) | Standard Error 0.01496 |
| 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=332, 333 | 0.3388 Micrograms per Liter (ug/L) | Standard Error 0.01983 |
| 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=334, 337 | 4.33 Micrograms per Liter (ug/L) | Standard Error 0.268 |
| 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=344, 346 | 15.2 Micrograms per Liter (ug/L) | Standard Error 1.12 |
| 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=345, 346 | 3.38 Micrograms per Liter (ug/L) | Standard Error 0.244 |
| 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=342, 342 | 0.2812 Micrograms per Liter (ug/L) | Standard Error 0.01406 |
| 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=345, 346 | 6.80 Micrograms per Liter (ug/L) | Standard Error 0.368 |
| 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=335, 337 | 13.3 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 | Serum Osteocalcin, Week 48, n=335, 336 | 6.30 Micrograms per Liter (ug/L) | Standard Error 0.384 |
p-value: <0.00195% CI: [-3.25, -2.08]MMRM
p-value: <0.00195% CI: [-3.75, -2.44]MMRM
p-value: <0.00195% CI: [-5.63, -3.71]MMRM
p-value: <0.00195% CI: [-6.89, -4.91]MMRM
p-value: <0.00195% CI: [-16.4, -10.6]MMRM
p-value: <0.00195% CI: [-15.4, -10.2]MMRM
p-value: <0.00195% CI: [-0.164, -0.09]MMRM
p-value: <0.00195% CI: [-0.2532, -0.1554]MMRM
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 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 | 4.8 Scores on a scale | Standard Error 0.44 |
| DTG + TDF/FTC - Double-blind Phase | Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144 | 4.5 Scores on a scale | Standard Error 0.51 |
p-value: 0.67495% CI: [-1, 1.6]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 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 | 4.4 Scores on a scale | Standard Error 0.45 |
| DTG + TDF/FTC - Double-blind Phase | Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96 | 5.1 Scores on a scale | Standard Error 0.52 |
p-value: 0.31895% CI: [-2.1, 0.7]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. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment 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 Utility Score at Week 144 | 0.0210 Scores on a scale | Standard Error 0.00346 |
| DTG + TDF/FTC - Double-blind Phase | Change From Baseline in EQ-5D-5L Utility Score at Week 144 | 0.0131 Scores on a scale | Standard Error 0.00441 |
p-value: 0.16295% CI: [-0.0032, 0.0189]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. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment 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 Utility Score at Week 96 | 0.0168 Scores on a scale | Standard Error 0.00339 |
| DTG + TDF/FTC - Double-blind Phase | Change From Baseline in EQ-5D-5L Utility Score at Week 96 | 0.0171 Scores on a scale | Standard Error 0.00424 |
p-value: 0.95795% CI: [-0.011, 0.0104]MMRM
Secondary
Change From Baseline in European Quality of Life [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. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment 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 (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC - Double-blind Phase | Change From Baseline in European Quality of Life [EuroQoL] - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48 | Week 48, n=360, 358 | 0.0189 Scores on a scale | Standard Error 0.00362 |
| DTG + 3TC - Double-blind Phase | Change From Baseline in European Quality of Life [EuroQoL] - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48 | Week 4, n=359, 355 | 0.0111 Scores on a scale | Standard Error 0.00326 |
| DTG + 3TC - Double-blind Phase | Change From Baseline in European Quality of Life [EuroQoL] - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48 | Week 24, n=360, 358 | 0.0207 Scores on a scale | Standard Error 0.0031 |
| DTG + TDF/FTC - Double-blind Phase | Change From Baseline in European Quality of Life [EuroQoL] - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48 | Week 4, n=359, 355 | 0.0130 Scores on a scale | Standard Error 0.0051 |
| DTG + TDF/FTC - Double-blind Phase | Change From Baseline in European Quality of Life [EuroQoL] - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48 | Week 24, n=360, 358 | 0.0203 Scores on a scale | Standard Error 0.00347 |
| DTG + TDF/FTC - Double-blind Phase | Change From Baseline in European Quality of Life [EuroQoL] - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48 | Week 48, n=360, 358 | 0.0208 Scores on a scale | Standard Error 0.00342 |
p-value: 0.75995% CI: [-0.0137, 0.01]MMRM
p-value: 0.94395% CI: [-0.0088, 0.0095]MMRM
p-value: 0.70395% CI: [-0.0117, 0.0079]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 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 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 (LEAST_SQUARES_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=358, 355 | 1.8 Scores on a scale | Standard Error 0.5 |
| 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=359, 358 | 3.9 Scores on a scale | Standard Error 0.43 |
| 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=359, 358 | 4.0 Scores on a scale | Standard Error 0.43 |
| 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=358, 355 | 3.1 Scores on a scale | Standard Error 0.41 |
| 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=359, 358 | 4.5 Scores on a scale | Standard Error 0.48 |
| 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=359, 358 | 4.6 Scores on a scale | Standard Error 0.48 |
p-value: 0.04595% CI: [-2.6, 0]MMRM
p-value: 0.35895% CI: [-1.9, 0.7]MMRM
p-value: 0.32895% CI: [-1.9, 0.6]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 is the latest pre-dose assessment (Day 1). 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 | 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 | -0.245 Ratio | Standard Error 0.0545 |
| DTG + TDF/FTC - Double-blind Phase | Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144 | -0.359 Ratio | Standard Error 0.0533 |
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 is the latest pre-dose assessment (Day 1). 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 | 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 | -0.113 Ratio | Standard Error 0.1552 |
| DTG + TDF/FTC - Double-blind Phase | Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96 | -0.395 Ratio | Standard Error 0.0473 |
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 (represented by n=X in the category titles).
| 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, n=263, 278 | 0.360 Millimoles per liter | Standard Error 0.0432 |
| 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, n=264, 278 | 0.180 Millimoles per liter | Standard Error 0.0162 |
| 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, n=263, 278 | 0.143 Millimoles per liter | Standard Error 0.0357 |
| 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, n=264, 278 | 0.078 Millimoles per liter | Standard Error 0.0448 |
| 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, n=264, 278 | -0.057 Millimoles per liter | Standard Error 0.043 |
| 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, n=263, 278 | -0.015 Millimoles per liter | Standard Error 0.0394 |
| 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, n=263, 278 | -0.085 Millimoles per liter | Standard Error 0.0333 |
| 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, n=264, 278 | 0.093 Millimoles per liter | Standard Error 0.0136 |
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 (represented by n=X in the category titles).
| 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, n=270, 289 | 0.345 Millimoles per liter | Standard Error 0.0356 |
| 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, n=271, 289 | 0.185 Millimoles per liter | Standard Error 0.016 |
| 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, n=270, 289 | 0.139 Millimoles per liter | Standard Error 0.0308 |
| 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, n=271, 289 | 0.105 Millimoles per liter | Standard Error 0.0488 |
| 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, n=271, 289 | -0.102 Millimoles per liter | Standard Error 0.0365 |
| 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, n=270, 289 | -0.132 Millimoles per liter | Standard Error 0.0375 |
| 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, n=270, 289 | -0.160 Millimoles per liter | Standard Error 0.0304 |
| 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, n=271, 289 | 0.071 Millimoles per liter | Standard Error 0.0136 |
Secondary
Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144
Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point 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 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 | -0.11 mg/L | Standard Error 0.005 |
| DTG + TDF/FTC - Double-blind Phase | Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144 | -0.08 mg/L | Standard Error 0.006 |
p-value: 0.00695% CI: [-0.04, -0.01]MMRM
Secondary
Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96
Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point 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 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 | -0.09 mg/L | Standard Error 0.006 |
| DTG + TDF/FTC - Double-blind Phase | Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96 | -0.08 mg/L | Standard Error 0.005 |
p-value: 0.03495% CI: [-0.03, 0]MMRM
Secondary
Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144
Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point 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 has been presented.
Time frame: Baseline 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 | 12.28 Micromoles per Liter (umol/L) | Standard Error 0.613 |
| DTG + TDF/FTC - Double-blind Phase | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144 | 15.14 Micromoles per Liter (umol/L) | Standard Error 0.583 |
p-value: <0.00195% CI: [-4.52, -1.19]MMRM
Secondary
Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96
Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point 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 has been presented.
Time frame: Baseline 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 | 11.71 Micromoles per Liter (umol/L) | Standard Error 0.563 |
| DTG + TDF/FTC - Double-blind Phase | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96 | 14.75 Micromoles per Liter (umol/L) | Standard Error 0.526 |
p-value: <0.00195% CI: [-4.56, -1.53]MMRM
Secondary
Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48
Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point 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 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=346, 344 | 10.51 Micromoles per Liter (umol/L) | Standard Deviation 0.548 |
| 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=335, 337 | 10.32 Micromoles per Liter (umol/L) | Standard Deviation 0.519 |
| 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=346, 344 | 13.53 Micromoles per Liter (umol/L) | Standard Deviation 0.507 |
| 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=335, 337 | 13.44 Micromoles per Liter (umol/L) | Standard Deviation 0.54 |
p-value: <0.00195% CI: [-4.49, -1.55]MMRM
p-value: <0.00195% CI: [-4.59, -1.65]MMRM
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. Change from Baseline was defined as value at indicated time point 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 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 | 0.560 Microgram per millimoles (ug/mmol) | Standard Deviation 9.5962 |
| DTG + TDF/FTC - Double-blind Phase | Change From Baseline in Renal Biomarker-Serum RBP at Week 144 | 3.813 Microgram per millimoles (ug/mmol) | Standard Deviation 10.8115 |
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. Change from Baseline was defined as value at indicated time point 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 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 | 0.557 Microgram per millimoles (ug/mmol) | Standard Deviation 12.7139 |
| DTG + TDF/FTC - Double-blind Phase | Change From Baseline in Renal Biomarker-Serum RBP at Week 96 | 2.483 Microgram per millimoles (ug/mmol) | Standard Deviation 23.9105 |
Secondary
Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48
Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C and Serum RBP. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point 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 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 (LEAST_SQUARES_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 48, n=334, 334 | 0.6 Milligrams per Liter (mg/L) | Standard Error 0.45 |
| 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=335,336 | -0.05 Milligrams per Liter (mg/L) | Standard Error 0.005 |
| 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=345,345 | -0.04 Milligrams per Liter (mg/L) | Standard Error 0.005 |
| 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=345,343 | 1.2 Milligrams per Liter (mg/L) | Standard Error 0.42 |
| 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=345,345 | 0.00 Milligrams per Liter (mg/L) | Standard Error 0.005 |
| 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=334, 334 | -0.1 Milligrams per Liter (mg/L) | Standard Error 0.42 |
| 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=345,343 | 1.4 Milligrams per Liter (mg/L) | Standard Error 0.48 |
| 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=335,336 | -0.04 Milligrams per Liter (mg/L) | Standard Error 0.006 |
p-value: <0.00195% CI: [-0.05, -0.02]MMRM
p-value: 0.02295% CI: [-0.03, 0]MMRM
p-value: 0.79795% CI: [-1.4, 1.1]MMRM
p-value: 0.25895% CI: [-0.5, 1.9]MMRM
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 samples were collected to perform evaluation of renal 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. Change from Baseline was defined as value at the indicated time point 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 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 24, n=345,345 | 3.8 Milliliter/minute/1.73 meter^2 | Standard Error 0.66 |
| 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=335,336 | 5.4 Milliliter/minute/1.73 meter^2 | Standard Error 0.64 |
| 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=346,344 | -12.0 Milliliter/minute/1.73 meter^2 | Standard Error 0.64 |
| 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=335, 337 | -12.1 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 48, n=335, 337 | -15.4 Milliliter/minute/1.73 meter^2 | Standard Error 0.61 |
| 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=345,345 | 0.2 Milliliter/minute/1.73 meter^2 | Standard Error 0.65 |
| 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=346,344 | -15.4 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 48, n=335,336 | 3.6 Milliliter/minute/1.73 meter^2 | Standard Error 0.64 |
p-value: <0.00195% CI: [1.8, 5.4]MMRM
p-value: 0.05695% CI: [0, 3.5]MMRM
p-value: <0.00195% CI: [1.7, 5.2]MMRM
p-value: <0.00195% CI: [1.6, 5]MMRM
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. Change from Baseline was defined as value at the indicated time point 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 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 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=301,304 | 10.3 Milliliter/minute/1.73 meter^2 | Standard Deviation 18.82 |
| 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=292,292 | -15.5 Milliliter/minute/1.73 meter^2 | Standard Deviation 12.56 |
| 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=301,304 | 10.1 Milliliter/minute/1.73 meter^2 | Standard Deviation 15.5 |
| 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=292,292 | -18.2 Milliliter/minute/1.73 meter^2 | Standard Deviation 11.73 |
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. Change from Baseline was defined as value at the indicated time point 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 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 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, n=316,326 | 9.1 Milliliter/minute/1.73 meter^2 | Standard Deviation 18.75 |
| 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, n=315,325 | -14.2 Milliliter/minute/1.73 meter^2 | Standard Deviation 12.69 |
| 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, n=316,326 | 9.5 Milliliter/minute/1.73 meter^2 | Standard Deviation 13.95 |
| 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, n=315,325 | -17.5 Milliliter/minute/1.73 meter^2 | Standard Deviation 11.57 |
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. Change from Baseline was defined as value at the indicated time point 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 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 | 301.7 Cells/mm^3 | Standard Error 11.55 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 | 296.6 Cells/mm^3 | Standard Error 13.55 |
p-value: 0.77795% CI: [-29.9, 40]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 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=25, 19 | 264.8 Cells/mm^3 | Standard Error 44.91 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Female, n=40, 37 | 355.0 Cells/mm^3 | Standard Error 34.93 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Age group, <35,n=171, 159 | 302.9 Cells/mm^3 | Standard Error 17.05 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Male, n=256, 255 | 287.7 Cells/mm^3 | Standard Error 13.81 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Baseline plasma HIV-1 RNA,>100000, n=55,58 | 338.2 Cells/mm^3 | Standard Error 30.34 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Race group, White, n=202, 211 | 300.0 Cells/mm^3 | Standard Error 15.61 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Age group-1, 35 to <50, n=95, 103 | 292.8 Cells/mm^3 | Standard Error 22.82 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Race group, African Am/African H., n=34, 24 | 256.4 Cells/mm^3 | Standard Error 38.04 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Baseline CD4+ cell count,>200, n=271, 273 | 300.3 Cells/mm^3 | Standard Error 13.54 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Race group, Asian, n=29, 25 | 258.5 Cells/mm^3 | Standard Error 41.57 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Age group-1, >=50, n=30, 30 | 274.1 Cells/mm^3 | Standard Error 40.71 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Race group, Other, n=31, 32 | 355.0 Cells/mm^3 | Standard Error 39.84 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Baseline plasma HIV-1 RNA,<=100000, n=241,234 | 286.8 Cells/mm^3 | Standard Error 14.36 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Race group, Other, n=31, 32 | 240.7 Cells/mm^3 | Standard Error 39.35 |
| 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=241,234 | 277.8 Cells/mm^3 | Standard Error 14.58 |
| 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=55,58 | 354.7 Cells/mm^3 | Standard Error 29.35 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Baseline CD4+ cell count,<=200, n=25, 19 | 208.9 Cells/mm^3 | Standard Error 51.25 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Baseline CD4+ cell count,>200, n=271, 273 | 297.9 Cells/mm^3 | Standard Error 13.48 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Age group, <35,n=171, 159 | 277.1 Cells/mm^3 | Standard Error 17.65 |
| 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=95, 103 | 329.2 Cells/mm^3 | Standard Error 22.02 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Age group-1, >=50, n=30, 30 | 250.0 Cells/mm^3 | Standard Error 40.6 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Female, n=40, 37 | 381.8 Cells/mm^3 | Standard Error 36.37 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Male, n=256, 255 | 279.6 Cells/mm^3 | Standard Error 13.85 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Race group, White, n=202, 211 | 296.5 Cells/mm^3 | Standard Error 15.29 |
| 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=34, 24 | 377.6 Cells/mm^3 | Standard Error 45.25 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups | Race group, Asian, n=29, 25 | 245.4 Cells/mm^3 | Standard Error 44.36 |
95% CI: [-31.1, 49.2]
95% CI: [-98.9, 65.8]
95% CI: [-77.2, 189.1]
95% CI: [-35.2, 39.9]
95% CI: [-22.3, 74]
95% CI: [-98.6, 25.8]
95% CI: [-89, 137.2]
95% CI: [-125.9, 72.2]
95% CI: [-30.3, 46.5]
95% CI: [-39.4, 46.3]
95% CI: [-237.2, -5.1]
95% CI: [-106.4, 132.6]
95% CI: [4.6, 224]
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+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted least 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 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 (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 and 48 | Week 24, n=349, 345 | 188.8 Cells/mm^3 | Standard Error 8.77 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 and 48 | Week 48, n=337, 340 | 225.7 Cells/mm^3 | Standard Error 8.94 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 and 48 | Week 24, n=349, 345 | 163.2 Cells/mm^3 | Standard Error 9.08 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 and 48 | Week 48, n=337, 340 | 217.2 Cells/mm^3 | Standard Error 9.93 |
p-value: 0.04395% CI: [0.8, 50.4]Mixed Model Repeated Measures (MMRM)
p-value: 0.52395% CI: [-17.7, 34.8]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 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 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 group-1, >=50, n=35, 33 | 198.74 Cells/mm^3 | Standard Error 28.411 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Baseline CD4+ cell count,>200, n=320, 319 | 189.91 Cells/mm^3 | Standard Error 9.362 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Female, n=52, 42 | 213.58 Cells/mm^3 | Standard Error 23.225 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Baseline plasma HIV-1 RNA,<=100000, n=283,273 | 186.01 Cells/mm^3 | Standard Error 9.948 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Male, n=297, 303 | 183.41 Cells/mm^3 | Standard Error 9.719 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Age group, <35,n= 201, 193 | 190.12 Cells/mm^3 | Standard Error 11.829 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Race group, White, n=236, 243 | 186.48 Cells/mm^3 | Standard Error 10.932 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Baseline CD4+ cell count,<=200, n=29, 26 | 167.95 Cells/mm^3 | Standard Error 31.308 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Race group, African Am/African H., n=48, 34 | 195.18 Cells/mm^3 | Standard Error 24.222 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Race group, Asian, n=33, 28 | 154.03 Cells/mm^3 | Standard Error 29.438 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Age group-1, 35 to <50, n=113, 119 | 180.50 Cells/mm^3 | Standard Error 15.733 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Race group, Other, n=32, 40 | 222.21 Cells/mm^3 | Standard Error 29.681 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Baseline plasma HIV-1 RNA,>100000, n=66,72 | 193.90 Cells/mm^3 | Standard Error 20.811 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Race group, Other, n=32, 40 | 160.20 Cells/mm^3 | Standard Error 26.627 |
| 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=283,273 | 148.21 Cells/mm^3 | Standard Error 10.134 |
| 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=66,72 | 220.71 Cells/mm^3 | Standard Error 19.814 |
| 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, 26 | 106.23 Cells/mm^3 | Standard Error 32.99 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Baseline CD4+ cell count,>200, n=320, 319 | 167.35 Cells/mm^3 | Standard Error 9.362 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Age group, <35,n= 201, 193 | 151.13 Cells/mm^3 | Standard Error 12.05 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Age group-1, 35 to <50, n=113, 119 | 190.40 Cells/mm^3 | Standard Error 15.404 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Age group-1, >=50, n=35, 33 | 133.21 Cells/mm^3 | Standard Error 29.12 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Female, n=52, 42 | 153.92 Cells/mm^3 | Standard Error 25.91 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Male, n=297, 303 | 164.18 Cells/mm^3 | Standard Error 9.631 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Race group, White, n=236, 243 | 167.44 Cells/mm^3 | Standard Error 10.79 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Race group, Asian, n=33, 28 | 141.24 Cells/mm^3 | Standard Error 31.703 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups | Race group, African Am/African H., n=48, 34 | 151.93 Cells/mm^3 | Standard Error 28.784 |
95% CI: [9.98, 65.62]
95% CI: [-82.72, 29.1]
95% CI: [-26.94, 150.39]
95% CI: [-3.42, 48.55]
95% CI: [5.88, 72.09]
95% CI: [-53.1, 33.3]
95% CI: [-14.43, 145.5]
95% CI: [-8.62, 127.94]
95% CI: [-7.65, 46.1]
95% CI: [-11.06, 49.13]
95% CI: [-30.59, 117.09]
95% CI: [-72.14, 97.73]
95% CI: [-16.09, 140.12]
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 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 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 (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Age group-1, <35,n= 193, 191 | 234.2 Cells/mm^3 | Standard Error 12.67 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Age group-2, >=50, n= 32, 32 | 208.5 Cells/mm^3 | Standard Error 31.27 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Baseline plasma HIV-1 RNA,>100000, n=64,69 | 261.8 Cells/mm^3 | Standard Error 22.27 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Female, n=48, 41 | 236.2 Cells/mm^3 | Standard Error 25.35 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Age group-1, 35 to <50, n=112, 117 | 212.7 Cells/mm^3 | Standard Error 16.59 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Male, n=289, 299 | 222.8 Cells/mm^3 | Standard Error 10.33 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Baseline CD4+ cell count,>200, n=309, 315 | 225.8 Cells/mm^3 | Standard Error 10 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Race group, White, n=230, 244 | 225.5 Cells/mm^3 | Standard Error 11.62 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Age group-1, >=50, n=32, 32 | 209.1 Cells/mm^3 | Standard Error 31.2 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Race group, African Am/African H., n=42, 31 | 201.2 Cells/mm^3 | Standard Error 27.16 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Baseline CD4+ cell count,<=200, n=28, 25 | 210.9 Cells/mm^3 | Standard Error 33.42 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Race group, Asian, n=33, 27 | 204.9 Cells/mm^3 | Standard Error 30.9 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Age group-2, <50,n= 305, 308 | 226.4 Cells/mm^3 | Standard Error 10.09 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Race group, Other, n=32, 38 | 270.2 Cells/mm^3 | Standard Error 31.15 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Baseline plasma HIV-1 RNA,<=100000, n=273,271 | 215.6 Cells/mm^3 | Standard Error 10.67 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Race group, Other, n=32, 38 | 232.6 Cells/mm^3 | Standard Error 28.67 |
| 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=273,271 | 208.7 Cells/mm^3 | Standard Error 10.71 |
| 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=64,69 | 248.7 Cells/mm^3 | Standard Error 21.3 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Baseline CD4+ cell count,<=200, n=28, 25 | 153.2 Cells/mm^3 | Standard Error 35.29 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Baseline CD4+ cell count,>200, n=309, 315 | 221.7 Cells/mm^3 | Standard Error 9.89 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Age group-1, <35,n= 193, 191 | 201.7 Cells/mm^3 | Standard Error 12.72 |
| 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=112, 117 | 244.2 Cells/mm^3 | Standard Error 16.31 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Age group-1, >=50, n=32, 32 | 203.9 Cells/mm^3 | Standard Error 31.06 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Age group-2, <50,n= 305, 308 | 217.8 Cells/mm^3 | Standard Error 10.03 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Age group-2, >=50, n= 32, 32 | 204.1 Cells/mm^3 | Standard Error 31.14 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Female, n=48, 41 | 263.6 Cells/mm^3 | Standard Error 27.5 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Male, n=289, 299 | 210.0 Cells/mm^3 | Standard Error 10.17 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Race group, White, n=230, 244 | 214.2 Cells/mm^3 | Standard Error 11.3 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Race group, African Am/African H., n=42, 31 | 239.0 Cells/mm^3 | Standard Error 31.64 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups | Race group, Asian, n=33, 27 | 189.3 Cells/mm^3 | Standard Error 33.88 |
95% CI: [-22.7, 36.6]
95% CI: [-46.8, 73.2]
95% CI: [-37.2, 152.5]
95% CI: [-23.5, 31.7]
95% CI: [-2.7, 67.7]
95% CI: [-77.1, 14.2]
95% CI: [-81.4, 91.8]
95% CI: [-19.4, 36.5]
95% CI: [-82.3, 91.3]
95% CI: [-100.8, 46.1]
95% CI: [-15.7, 41.2]
95% CI: [-20.4, 43.1]
95% CI: [-119.6, 44]
95% CI: [-74.4, 105.7]
95% CI: [-45.4, 120.5]
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. Change from Baseline was defined as value at the indicated time point 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 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 | 272.0 Cells/mm^3 | Standard Error 10.83 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 | 264.6 Cells/mm^3 | Standard Error 11.18 |
p-value: 0.63595% CI: [-23.2, 38]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 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 | Age group-1, >=50, n=31, 30 | 265.8 Cells/mm^3 | Standard Error 36.14 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Baseline CD4+ cell count,>200, n=293, 304 | 272.3 Cells/mm^3 | Standard Error 11.73 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Female, n=44, 40 | 312.7 Cells/mm^3 | Standard Error 30.12 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Baseline plasma HIV-1 RNA,<=100000, n=259,260 | 257.9 Cells/mm^3 | Standard Error 12.47 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Male, n=274, 287 | 261.4 Cells/mm^3 | Standard Error 12.07 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Age group-1, <35,n= 186, 187 | 266.0 Cells/mm^3 | Standard Error 14.74 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Race group, White, n=221, 234 | 272.1 Cells/mm^3 | Standard Error 13.49 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Baseline CD4+ cell count,<=200, n=25, 23 | 229.4 Cells/mm^3 | Standard Error 40.41 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Race group, African Am/African H., n=35, 30 | 246.3 Cells/mm^3 | Standard Error 33.9 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Race group, Asian, n=31, 27 | 224.0 Cells/mm^3 | Standard Error 36.31 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Age group-1, 35 to <50, n=101, 110 | 273.6 Cells/mm^3 | Standard Error 19.95 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Race group, Other, n=31, 36 | 312.0 Cells/mm^3 | Standard Error 36.01 |
| DTG + 3TC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Baseline plasma HIV-1 RNA,>100000, n=59,67 | 312.1 Cells/mm^3 | Standard Error 26.37 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Race group, Other, n=31, 36 | 278.9 Cells/mm^3 | Standard Error 33.56 |
| 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=259,260 | 257.5 Cells/mm^3 | Standard Error 12.45 |
| 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=59,67 | 297.4 Cells/mm^3 | Standard Error 24.59 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Baseline CD4+ cell count,<=200, n=25, 23 | 202.9 Cells/mm^3 | Standard Error 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=293, 304 | 269.4 Cells/mm^3 | Standard Error 11.5 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Age group-1, <35,n= 186, 187 | 257.7 Cells/mm^3 | Standard Error 14.68 |
| 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=101, 110 | 286.8 Cells/mm^3 | Standard Error 19.22 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Age group-1, >=50, n=31, 30 | 233.1 Cells/mm^3 | Standard Error 36.61 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Female, n=44, 40 | 307.6 Cells/mm^3 | Standard Error 31.67 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Male, n=274, 287 | 259.3 Cells/mm^3 | Standard Error 11.81 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Race group, White, n=221, 234 | 258.3 Cells/mm^3 | Standard Error 13.14 |
| DTG + TDF/FTC - Double-blind Phase | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups | Race group, Asian, n=31, 27 | 264.0 Cells/mm^3 | Standard Error 38.57 |
| 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=35, 30 | 303.7 Cells/mm^3 | Standard Error 36.61 |
95% CI: [-34.1, 35]
95% CI: [-55.6, 84.9]
95% CI: [-87.3, 140.3]
95% CI: [-29.4, 35.1]
95% CI: [-32.5, 49.1]
95% CI: [-67.6, 41.1]
95% CI: [-68.5, 133.9]
95% CI: [-80.7, 90.8]
95% CI: [-31.1, 35.3]
95% CI: [-23.2, 50.6]
95% CI: [-155.3, 40.4]
95% CI: [-144.2, 64]
95% CI: [-63.3, 129.6]
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 | 13 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants Who Discontinue Treatment Due to AEs Over Week 144 | 16 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 Weeks 24, 48 and 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 | Week 48 | 8 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96 | Week 24 | 6 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96 | Week 96 | 10 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96 | Week 24 | 4 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96 | Week 48 | 8 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96 | Week 96 | 12 Participants |
Secondary
Number of Participants With AEs by Maximum Severity Grades 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. AEs were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (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 148
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 148 | Grade 2 AEs | 211 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With AEs by Maximum Severity Grades up to Week 148 | Grade 4 AEs | 7 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With AEs by Maximum Severity Grades up to Week 148 | Grade 3 AEs | 32 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With AEs by Maximum Severity Grades up to Week 148 | Grade 5 AEs | 2 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With AEs by Maximum Severity Grades up to Week 148 | Grade 1 AEs | 54 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With AEs by Maximum Severity Grades up to Week 148 | Grade 5 AEs | 1 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With AEs by Maximum Severity Grades up to Week 148 | Grade 1 AEs | 54 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With AEs by Maximum Severity Grades up to Week 148 | Grade 2 AEs | 205 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With AEs by Maximum Severity Grades up to Week 148 | Grade 3 AEs | 43 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With AEs by Maximum Severity Grades up to Week 148 | Grade 4 AEs | 6 Participants |
Secondary
Number of Participants With Any Adverse Event (AE) and Serious AE (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 Adverse Event (AE) and Serious AE (SAE) up to Week 148 | Any AE | 306 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Any Adverse Event (AE) and Serious AE (SAE) up to Week 148 | Any SAE | 39 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Any Adverse Event (AE) and Serious AE (SAE) up to Week 148 | Any AE | 309 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Any Adverse Event (AE) and Serious AE (SAE) up to Week 148 | Any SAE | 47 Participants |
Secondary
Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade 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. 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 148
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 148 | Any drug related AE | 69 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 148 | Drug related AEs with maximum toxicity Grade 1 | 37 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 148 | Drug related AEs with maximum toxicity Grade 2 | 26 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 148 | Drug related AEs with maximum toxicity Grade 3 | 5 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 148 | Drug related AEs with maximum toxicity Grade 4 | 1 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 148 | 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 148 | Drug related AEs with maximum toxicity Grade 4 | 1 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 148 | Any drug related AE | 91 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 148 | Drug related AEs with maximum toxicity Grade 3 | 8 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 148 | Drug related AEs with maximum toxicity Grade 1 | 53 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 148 | 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 148 | Drug related AEs with maximum toxicity Grade 2 | 29 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. Participants may have more than one indicators of clinical disease progression including death, hence they may contribute to data in more than one categories.
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 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 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, 2 or 3 to Death | 2 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With HIV-1 Disease Progression up to Week 144 | No 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, 2 or 3 to Death | 1 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With HIV-1 Disease Progression up to Week 144 | No disease progression | 357 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 | 1 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), 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 | Hypoglycaemia, Grade 1 | 16 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 | GFR, Grade 3 | 20 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR, Grade 2 | 178 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR, 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 | 4 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, 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 | Hypercalcemia, Grade 1 | 4 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 3 | 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 | Hyperglycaemia, Grades 1 to 4 | 106 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycaemia, Grades 2 to 4 | 49 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycaemia, 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 | Hyperglycaemia, Grade 1 | 57 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycaemia, Grade 2 | 46 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycaemia, Grade 3 | 2 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycaemia, Grade 4 | 1 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 | 7 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 | 2 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 | 1 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperkalemia, Grade 1 | 5 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperkalemia, Grade 2 | 1 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 | 1 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 | 4 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 | 1 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 | 3 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypernatremia, Grade 2 | 1 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 | 17 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 | 6 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 | 1 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypocalcaemia, Grade 1 | 11 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypocalcaemia, Grade 2 | 5 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypocalcaemia, Grade 3 | 1 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 | Hypoglycaemia, 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 | Hypoglycaemia, Grades 2 to 4 | 6 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycaemia, 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 | Hypoglycaemia, Grade 2 | 2 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycaemia, Grade 3 | 3 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycaemia, 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 1 to 4 | 9 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 | 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 | 9 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 | ALT, 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 | ALT, Grades 2 to 4 | 30 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 | 13 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALT, Grade 1 | 47 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALT, Grade 2 | 17 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALT, Grade 3 | 6 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 | Albumin, Grades 1 to 4 | 2 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 | 2 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 | 2 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 | 10 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 | 2 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 | 8 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALP, Grade 2 | 2 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 | 71 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 | 30 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 | 15 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | AST, Grade 1 | 41 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | AST, Grade 2 | 15 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | AST, Grade 3 | 8 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | AST, Grade 4 | 7 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 | 46 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 | 13 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 1 | 33 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Bilirubin, Grade 2 | 9 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Bilirubin, Grade 3 | 0 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Bilirubin, Grade 4 | 4 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 | 111 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 | 10 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 | 101 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CO2, Grade 2 | 10 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 | 98 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 | 23 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 | 1 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Cholesterol, Grade 1 | 75 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Cholesterol, Grade 2 | 22 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Cholesterol, Grade 3 | 1 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 | 91 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 | 49 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 | 29 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grade 1 | 42 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grade 2 | 20 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grade 3 | 11 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grade 4 | 18 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 | 18 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 | 5 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 | 13 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Creatinine, Grade 2 | 5 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 | Direct Bilirubin, Grades 1 to 4 | 11 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 | 11 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 | 11 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 | 11 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 | GFR, Grades 1 to 4 | 198 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR, Grades 2 to 4 | 198 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR, Grades 3 to 4 | 20 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR, Grade 1 | 0 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 | 3 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 | Lactate Dehydrogenase, Grade 1 | 1 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lactate Dehydrogenase, Grade 2 | 3 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 1 to 4 | 72 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 | 37 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grade 3 | 6 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 | 9 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grade 1 | 35 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grade 2 | 28 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grade 4 | 3 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 | 75 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 | 50 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 | 7 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Phosphate, Grade 1 | 25 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Phosphate, Grade 2 | 43 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Phosphate, Grade 3 | 7 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 | 89 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 | 22 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 | 4 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Triglycerides, Grade 1 | 67 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Triglycerides, Grade 2 | 18 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 | 23 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 | 0 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 | 0 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 | 66 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 | 21 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 | 6 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | LDL Cholesterol, Grade 1 | 45 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | LDL Cholesterol, Grade 2 | 15 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | LDL Cholesterol, Grade 3 | 6 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 | 4 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Triglycerides, Grade 3 | 4 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Triglycerides, 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 1 | 40 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperkalemia, Grade 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, 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 | GFR, Grade 3 | 28 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR, Grade 2 | 190 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 | GFR, Grade 1 | 0 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 | 1 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Bilirubin, Grade 3 | 2 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR, Grade 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 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 | Hypercalcaemia, 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 | Bilirubin, Grade 4 | 1 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 | 1 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 | 40 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 | 1 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 | 111 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypercalcemia, Grade 1 | 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 1 | 2 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 | CO2, Grades 2 to 4 | 4 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 | Triglycerides, Grade 1 | 60 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypercalcaemia, Grade 4 | 1 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 | Hyperglycaemia, Grades 1 to 4 | 86 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 | 0 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycaemia, Grades 2 to 4 | 38 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 | Hyperglycaemia, 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 | LDL Cholesterol, Grade 3 | 2 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycaemia, Grade 1 | 48 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CO2, Grade 2 | 4 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperglycaemia, Grade 2 | 35 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 | Hyperglycaemia, Grade 3 | 2 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 | Hyperglycaemia, Grade 4 | 1 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Triglycerides, Grade 2 | 14 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 | 7 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 | 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 | 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 | 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 1 to 4 | 50 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperkalemia, Grade 1 | 6 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 | Cholesterol, Grades 2 to 4 | 12 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyperkalemia, Grade 3 | 1 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 | 81 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 | 0 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 | 7 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 | 13 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 | Cholesterol, Grade 1 | 38 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 | Lipase, Grades 2 to 4 | 43 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypernatremia, Grade 1 | 7 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 | 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 | Hyponatremia, Grades 1 to 4 | 22 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 | Cholesterol, 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, 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, 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 1 to 4 | 21 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 | Hypocalcaemia, Grades 2 to 4 | 11 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 | 17 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 | 3 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 | 83 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 | Hyponatremia, 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 | Hypocalcaemia, Grade 2 | 8 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 | 47 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypocalcaemia, Grade 3 | 2 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grade 1 | 38 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypocalcaemia, Grade 4 | 1 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 | 28 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycaemia, Grades 1 to 4 | 21 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 | 2 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycaemia, Grades 2 to 4 | 5 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grade 1 | 36 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycaemia, 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 | 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 | Hypoglycaemia, Grade 1 | 16 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grade 2 | 26 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycaemia, Grade 2 | 4 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grade 2 | 19 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycaemia, Grade 3 | 0 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Lipase, Grade 3 | 13 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypoglycaemia, Grade 4 | 1 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | CK, Grade 3 | 11 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 | 5 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 | 1 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 | CK, Grade 4 | 17 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 | Lipase, Grade 4 | 4 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hypokalemia, Grade 1 | 4 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 | 28 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 | 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 | 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 | Creatinine, Grades 2 to 4 | 2 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 | 78 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 | 71 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 | 1 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 | 29 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyponatremia, Grade 1 | 19 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 | 15 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Creatinine, Grade 1 | 26 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALT, Grade 1 | 42 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 | 51 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALT, Grade 2 | 14 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 | ALT, Grade 3 | 8 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 | 27 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALT, Grade 4 | 7 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Creatinine, Grade 3 | 1 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 | Phosphate, Grades 3 to 4 | 7 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 | 1 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 | Albumin, 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 | Hyponatremia, Grade 2 | 2 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Albumin, 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, 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 | 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 | Phosphate, Grade 1 | 27 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Albumin, Grade 3 | 1 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 | 10 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 | Triglycerides, 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 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 | Direct Bilirubin, Grades 3 to 4 | 10 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 | 3 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Phosphate, Grade 2 | 44 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 | 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 1 | 0 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | ALP, Grade 1 | 14 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 | ALP, Grade 2 | 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 2 | 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 | 1 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Phosphate, Grade 3 | 7 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 | Direct Bilirubin, Grade 3 | 10 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 | 83 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 | AST, Grades 2 to 4 | 32 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 | AST, Grades 3 to 4 | 14 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 | 11 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | AST, Grade 1 | 51 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR, Grades 1 to 4 | 219 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 | Triglycerides, 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 | AST, Grade 3 | 11 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR, Grades 2 to 4 | 219 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | AST, Grade 4 | 3 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | Hyponatremia, Grade 4 | 1 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 | 56 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 | GFR, Grades 3 to 4 | 29 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 | 16 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 | 15 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 | 3 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 | 2 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 platelet count. 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 | Leukocytes, Grades 1 to 4 | 5 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 | 23 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Hemoglobin, Grade 2 | 4 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 | 8 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 | 1 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 | 4 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 | 2 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Neutrophils, Grade 1 | 15 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 | Neutrophils, Grade 2 | 4 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Hemoglobin, Grade 3 | 1 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Neutrophils, Grade 3 | 2 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Leukocytes, Grade 1 | 4 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 | Hemoglobin, Grades 2 to 4 | 6 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 | 13 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Leukocytes, Grade 2 | 1 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 | 5 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Hemoglobin, Grade 4 | 1 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 | 0 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, Grade 1 | 8 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Platelets, Grade 2 | 5 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 | 8 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 | Leukocytes, Grade 4 | 0 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Platelets, 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 1 | 2 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 | Platelets, Grade 1 | 4 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 | 10 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 | 6 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 | 1 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Hemoglobin, Grade 1 | 4 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Hemoglobin, Grade 2 | 5 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Hemoglobin, Grade 3 | 1 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 | 5 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 | 0 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 | 5 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Leukocytes, Grade 2 | 0 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 | 7 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 | 3 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 | 1 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Neutrophils, Grade 1 | 4 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Neutrophils, Grade 2 | 2 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Neutrophils, Grade 3 | 1 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Neutrophils, Grade 4 | 0 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 | 9 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 | 5 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 | 0 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Platelets, Grade 2 | 5 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 | Platelets, Grade 3 | 0 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 the 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 the NRTI | 0 Participants |
Secondary
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144
Number of participants, who met 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 were interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drugs (DTG, 3TC, Abacavir \[ABC\], elvitegravir \[EGV\], raltegravir \[RAL\], zidovudine \[AZT\], stavudine \[D4T\], didanosine \[DDI\]), emtricitabine \[FTC\], tenofovir disiproxil fumarate \[TDF\]). Partially sensitive and resistant cells 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 | NRTI, AZT, Sensitive, n=7,3 | 7 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, RAL, Resistant, n=7,2 | 0 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, AZT, Resistant, n=7,3 | 0 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, DTG, Resistant, n=7,2 | 0 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, D4T, Sensitive, n=7,3 | 7 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, 3TC, Sensitive, n=7,3 | 7 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, D4T, Resistant, n=7,3 | 0 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, EGV, Resistant, n=7,2 | 0 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, DDI, Sensitive, n=7,3 | 7 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, 3TC, Resistant, n=7,3 | 0 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, DDI, Resistant, n=7,3 | 0 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, DTG, Sensitive, n=7,2 | 7 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, FTC, Sensitive, n=7,3 | 7 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, ABC, Sensitive, n=7,3 | 7 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, FTC, Resistant, n=7,3 | 0 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, RAL, Sensitive, n=7,2 | 7 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, TDF, Sensitive, n=7,3 | 7 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, ABC, Resistant, n=7,3 | 0 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, TDF, Resistant, n=7,3 | 0 Participants |
| DTG + 3TC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, EGV, Sensitive, n=7,2 | 7 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, TDF, Resistant, n=7,3 | 0 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, DTG, Resistant, n=7,2 | 0 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, EGV, Sensitive, n=7,2 | 2 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, EGV, Resistant, n=7,2 | 0 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, RAL, Sensitive, n=7,2 | 2 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, RAL, Resistant, n=7,2 | 0 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, 3TC, Sensitive, n=7,3 | 3 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, 3TC, Resistant, n=7,3 | 0 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, ABC, Sensitive, n=7,3 | 3 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, ABC, Resistant, n=7,3 | 0 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, AZT, Sensitive, n=7,3 | 3 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, AZT, Resistant, n=7,3 | 0 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, D4T, Sensitive, n=7,3 | 3 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, D4T, Resistant, n=7,3 | 0 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, DDI, Sensitive, n=7,3 | 3 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, DDI, Resistant, n=7,3 | 0 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, FTC, Sensitive, n=7,3 | 3 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, FTC, Resistant, n=7,3 | 0 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | NRTI, TDF, Sensitive, n=7,3 | 3 Participants |
| DTG + TDF/FTC - Double-blind Phase | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 | INSTI, DTG, Sensitive, n=7,2 | 2 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). Lipid last observation carried forwarded (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. Participants on lipid-lowering agents at Baseline were excluded.
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=298, 310 | -4.4 Percentage change | Standard Deviation 22.53 |
| 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=298, 307 | -2.8 Percentage change | Standard Deviation 17.86 |
| 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=298, 310 | -7.5 Percentage change | Standard Deviation 17.9 |
| 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=298, 307 | -4.5 Percentage change | Standard Deviation 18.25 |
Secondary
Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (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 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 High Density Lipoprotein (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=298, 307 | 9.3 Percentage change | Standard Deviation 17.1 |
| DTG + 3TC - Double-blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (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=298, 309 | 3.8 Percentage change | Standard Deviation 25.85 |
| DTG + 3TC - Double-blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (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=298, 310 | 5.0 Percentage change | Standard Deviation 16.85 |
| DTG + 3TC - Double-blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (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=297, 307 | 10.7 Percentage change | Standard Deviation 27.54 |
| DTG + 3TC - Double-blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (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=299, 310 | 13.9 Percentage change | Standard Deviation 25.17 |
| DTG + 3TC - Double-blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | Triglycerides,Week 24, n=299, 310 | 7.0 Percentage change | Standard Deviation 40.45 |
| DTG + 3TC - Double-blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (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=299, 307 | 15.3 Percentage change | Standard Deviation 23.75 |
| DTG + 3TC - Double-blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | Triglycerides, Week 48, n=299, 307 | 7.3 Percentage change | Standard Deviation 46.92 |
| DTG + TDF/FTC - Double-blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (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=299, 307 | 4.0 Percentage change | Standard Deviation 21.86 |
| DTG + TDF/FTC - Double-blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | Triglycerides, Week 48, n=299, 307 | -0.3 Percentage change | Standard Deviation 49.22 |
| DTG + TDF/FTC - Double-blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (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=298, 310 | -4.5 Percentage change | Standard Deviation 15.44 |
| DTG + TDF/FTC - Double-blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (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=298, 307 | -3.3 Percentage change | Standard Deviation 14.61 |
| DTG + TDF/FTC - Double-blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (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=299, 310 | 7.2 Percentage change | Standard Deviation 32.22 |
| DTG + TDF/FTC - Double-blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (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=298, 309 | -7.8 Percentage change | Standard Deviation 21.13 |
| DTG + TDF/FTC - Double-blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (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=297, 307 | -4.1 Percentage change | Standard Deviation 20.39 |
| DTG + TDF/FTC - Double-blind Phase | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 | Triglycerides,Week 24, n=299, 310 | 0.5 Percentage change | Standard Deviation 44.01 |
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-off.
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=54, 46 | 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 | Baseline plasma HIV-1 RNA, <=100000,n=294, 282 | 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 144 | Age, <35,n= 209, 203 | 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 144 | Baseline plasma HIV-1 RNA, >100000,n=66, 77 | 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 144 | Baseline CD4+ cell count, >200,n=328,333 | 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 144 | Race, White, n=240,252 | 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 144 | Age, 35 to <50,n=115, 122 | 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 144 | Race, African American/African H., n=51, 35 | 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 144 | Male, n=306, 313 | 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 144 | Race, Asian, n=34, 30 | 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 144 | Age, >=50, n=36, 34 | 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 144 | Race, Other, n=35, 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 144 | Baseline CD4+ cell count, <=200,n=32, 26 | 75 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=35, 42 | 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 | Baseline CD4+ cell count, <=200,n=32, 26 | 69 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=328,333 | 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 144 | Female, n=54, 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 | Male, n=306, 313 | 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 | Age, <35,n= 209, 203 | 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, 35 to <50,n=115, 122 | 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 | Age, >=50, n=36, 34 | 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 144 | Baseline plasma HIV-1 RNA, <=100000,n=294, 282 | 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 | Baseline plasma HIV-1 RNA, >100000,n=66, 77 | 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 | Race, White, n=240,252 | 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, African American/African H., n=51, 35 | 74 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=34, 30 | 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 cells/mm\^3, \>200 cells/mm\^3 for group-1), Baseline HIV-1 RNA (\<=100000, \>100000 c/mL) and Race (White, African American/African heritage (H.), Asian other). Percentage values are rounded-off.
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 | Female, n=54, 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=294,282 | 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 | Age, <35,n= 209, 203 | 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=66, 77 | 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 | Baseline CD4+ cell count Group-1, >200,n=328,333 | 95 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=240, 252 | 95 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=115, 122 | 96 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, African American/African H., n=51, 35 | 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 | Male, n=306, 313 | 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 | Race, Asian, n=34, 30 | 97 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=36, 34 | 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 | Race, Other, n=35, 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 | Baseline CD4+ cell count Group-1, <=200,n=32,26 | 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 24 | Race, Other, n=35, 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 CD4+ cell count Group-1, <=200,n=32,26 | 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 | Baseline CD4+ cell count Group-1, >200,n=328,333 | 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 | Female, n=54, 46 | 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 24 | Male, n=306, 313 | 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= 209, 203 | 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 | Age, 35 to <50,n=115, 122 | 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 | Age, >=50, n=36, 34 | 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 24 | Baseline plasma HIV-1 RNA, <=100000,n=294,282 | 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 | Baseline plasma HIV-1 RNA, >100000,n=66, 77 | 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 24 | Race, White, n=240, 252 | 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=51, 35 | 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 24 | Race, Asian, n=34, 30 | 90 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 cells/mm\^3, \>200 cells/mm\^3 for group-1), Baseline HIV-1 RNA (\<=100000, \>100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded-off.
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=54, 46 | 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 | Baseline plasma HIV-1 RNA, <=100000,n=294,282 | 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 | Age, <35,n= 209,203 | 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=66, 77 | 97 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 Group-1, >200,n=328,333 | 95 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=240, 252 | 96 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=115, 122 | 97 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=51, 35 | 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 48 | Male, n=306, 313 | 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 48 | Race, Asian, n=34, 30 | 97 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=36, 34 | 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 | Race, Other, n=35, 42 | 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 | Baseline CD4+ cell count Group-1, <=200,n=32, 26 | 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 48 | Race, Other, n=35, 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 48 | Baseline CD4+ cell count Group-1, <=200,n=32, 26 | 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 48 | Baseline CD4+ cell count Group-1, >200,n=328,333 | 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 | Female, n=54, 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 | Male, n=306, 313 | 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 48 | Age, <35,n= 209,203 | 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, 35 to <50,n=115, 122 | 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=36, 34 | 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 | Baseline plasma HIV-1 RNA, <=100000,n=294,282 | 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 48 | Baseline plasma HIV-1 RNA, >100000,n=66, 77 | 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 | Race, White, n=240, 252 | 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 48 | Race, African American/African H., n=51, 35 | 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 48 | Race, Asian, n=34, 30 | 90 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-off.
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 | Male, n=306, 313 | 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 96 | Baseline plasma HIV-1 RNA, <=100000,n=294, 282 | 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 96 | Baseline CD4+ cell count, <=200,n=32, 26 | 72 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=66, 77 | 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, <35,n= 209, 203 | 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 96 | Race, White, n=240,252 | 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 96 | Female, n=54, 46 | 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, African American/African H., n=51, 35 | 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 96 | Baseline CD4+ cell count, >200,n=328,333 | 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 96 | Race, Asian, n=34, 30 | 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 96 | Age, >=50, n=36, 34 | 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 | Race, Other, n=35, 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 96 | Age, 35 to <50,n=115, 122 | 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=35, 42 | 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 96 | Baseline CD4+ cell count, <=200,n=32, 26 | 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 96 | Baseline CD4+ cell count, >200,n=328,333 | 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 | Female, n=54, 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 96 | Male, n=306, 313 | 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, <35,n= 209, 203 | 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 to <50,n=115, 122 | 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, >=50, n=36, 34 | 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=294, 282 | 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 | Baseline plasma HIV-1 RNA, >100000,n=66, 77 | 84 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=240,252 | 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 | Race, African American/African H., n=51, 35 | 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, Asian, n=34, 30 | 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-off.
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 | 6 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: 0.1695% CI: [-0.8, 6]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-off.
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 | 6 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 | 2 Percentage of participants |
p-value: 0.04595% CI: [0.2, 6.1]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 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-off.
Time frame: Weeks 24 and 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=313, 320 | 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=324, 332 | 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 24, n=313, 320 | 0 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=324, 332 | 2 Percentage of participants |
p-value: <0.00195% CI: [1.5, 5.6]Fisher Exact
p-value: 0.03795% CI: [0.2, 5.4]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 off.
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 | 84 Percentage of participants |
| DTG + TDF/FTC - Double-blind Phase | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144 | 84 Percentage of participants |
95% CI: [-5.3, 5.3]
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 CMH weights. Percentage values are rounded off.
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 | 94 Percentage of participants |
| DTG + TDF/FTC - Double-blind Phase | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24 | 94 Percentage of participants |
95% CI: [-3.4, 3.6]
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 CMH weights. Percentage values are rounded off.
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 | 88 Percentage of participants |
| DTG + TDF/FTC - Double-blind Phase | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96 | 90 Percentage of participants |
95% CI: [-6.4, 2.7]
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: Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor.
Time frame: Baseline 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 (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 RBP 4/Urine Creatinine, Week 144, n=294, 289 | 1.159 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 Albumin/Creatinine, Week 144, n=230, 221 | 1.036 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=108, 93 | 0.872 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=301, 301 | 1.083 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=236, 246 | 0.999 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=236, 246 | 1.180 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=301, 301 | 1.084 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=230, 221 | 1.067 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=294, 289 | 1.567 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=108, 93 | 1.494 Ratio |
p-value: 0.65895% CI: [0.852, 1.107]MMRM
p-value: <0.00195% CI: [0.483, 0.706]MMRM
p-value: 0.99395% CI: [0.892, 1.12]MMRM
p-value: <0.00195% CI: [0.785, 0.913]MMRM
p-value: <0.00195% CI: [0.667, 0.819]MMRM
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: Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor.
Time frame: Baseline 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 B2M/Urine Creatinine, Week 96, n=101, 96 | 0.844 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=251, 261 | 0.887 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=316, 322 | 1.156 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=314, 318 | 1.030 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 Albumin/Creatinine, Week 96, n=239, 243 | 0.939 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=314, 318 | 1.287 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=239, 243 | 0.997 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=101, 96 | 1.259 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=316, 322 | 1.069 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=251, 261 | 1.016 Ratio |
p-value: <0.00195% CI: [0.806, 0.946]MMRM
p-value: <0.00195% CI: [0.716, 0.894]MMRM
p-value: 0.33895% CI: [0.833, 1.065]MMRM
p-value: <0.00195% CI: [0.545, 0.826]MMRM
p-value: 0.17495% CI: [0.966, 1.213]MMRM
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: 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 was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Geometric mean ratio and 95% CI of geometric mean ratio have been presented. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor.
Time frame: Baseline and 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 24, n=344,346 | 0.809 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 48, n=335,336 | 0.811 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=124,106 | 0.844 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=109, 103 | 0.917 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=259, 251 | 0.907 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=249, 240 | 0.911 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=122, 104 | 0.880 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=108, 103 | 0.969 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=343, 340 | 1.041 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=335, 332 | 1.121 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=263,279 | 0.818 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=259, 261 | 0.866 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=340, 338 | 0.656 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=333, 331 | 0.740 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=338, 335 | 0.670 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=331, 328 | 0.749 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=331, 328 | 0.844 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=344,346 | 0.882 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=343, 340 | 1.063 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=335,336 | 0.887 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=340, 338 | 0.824 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=124,106 | 1.129 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=335, 332 | 1.056 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=109, 103 | 1.323 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=338, 335 | 0.811 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=259, 251 | 1.021 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=263,279 | 0.991 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=249, 240 | 0.971 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=333, 331 | 0.819 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=122, 104 | 1.126 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=259, 261 | 1.007 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=108, 103 | 1.307 Ratio |
p-value: <0.00195% CI: [0.893, 0.941]MMRM
p-value: <0.00195% CI: [0.89, 0.939]MMRM
p-value: 0.00295% CI: [0.621, 0.901]MMRM
p-value: 0.00595% CI: [0.538, 0.892]MMRM
p-value: 0.03695% CI: [0.796, 0.992]MMRM
p-value: 0.30895% CI: [0.83, 1.061]MMRM
p-value: 0.00795% CI: [0.654, 0.934]MMRM
p-value: 0.01295% CI: [0.588, 0.935]MMRM
p-value: 0.72895% CI: [0.868, 1.104]MMRM
p-value: 0.31195% CI: [0.945, 1.194]MMRM
p-value: <0.00195% CI: [0.769, 0.887]MMRM
p-value: <0.00195% CI: [0.795, 0.93]MMRM
p-value: 0.00395% CI: [0.683, 0.927]MMRM
p-value: 0.295% CI: [0.773, 1.056]MMRM
p-value: 0.00395% CI: [0.728, 0.936]MMRM
p-value: 0.05295% CI: [0.787, 1.001]MMRM
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: 0.79795% CI: [0.88, 1.19]Generalised Wilcoxon procedure