HIV Infections, Infection, Human Immunodeficiency Virus
Conditions
Keywords
integrase inhibitor, Mycobacterium tuberculosis, rifampicin-sensitive, dolutegravir, antiretroviral therapy-naïve, HIV-1 infection, efavirenz, co-infection
Brief summary
HIV/Tuberculosis (TB) co-infection have profound effects on the host's immune system. TB is the most common cause of death in patients with HIV worldwide. Rifamycins (such as rifampicin \[RIF\]) are an important component of TB therapy because of their unique activity. The problem is that most protease inhibitors (PI) and non-nucleoside reverse transcriptase inhibitors (NNRTI) used to treat HIV have significant drug-drug interactions with RIF that can lead to reduced concentrations of these agents with risk of treatment failure or resistance. The non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV) does not present the same significant drug interactions with RIF. EFV-based HIV treatment was tested in patients concomitantly treated with RIF-containing TB therapy, demonstrating that their co-administration can be used safely and effectively. However, the side effect profile of EFV overlaps with the RIF-containing TB regimens and makes the management of treatment toxicities very complex. Integrase inhibitors (INI), such as dolutegravir (DTG), may offer an important alternative to EFV-based therapy in TB coinfected patients. A Phase I drug-drug interaction study was conducted in healthy, HIV-seronegative subjects, and showed that DTG at 50 mg twice daily given together with RIF was well-tolerated and resulted in DTG concentrations similar to those of DTG 50 mg given once daily alone, which is the recommended dose for INI-naive patients. Therefore, ART regimens using DTG 50 mg twice daily may represent a new treatment option for TB-infected patients who require concurrent treatment for HIV infection. This is a Phase III b, randomized, open-label study describing the efficacy and safety of DTG and EFV-containing ART regimens in HIV/TB co-infected patients. This study is designed to assess the antiviral activity of DTG or efavirenz (EFV) ART-containing regimens through 48 weeks. A total of approximately 115 +/-5% subjects will be randomly assigned in a 3:2 ratio to DTG (approximately 69 subjects) and EFV (approximately 46 subjects), respectively. This study will include a Screening Period, a Randomized Phase (Day 1 to 48 weeks plus a 4-week extension), and a DTG Open-label extension (OLE). During the DTG OLE, subjects will be supplied with DTG until it is locally approved and commercially available, the subject no longer derives clinical benefit, or the subject meets a protocol-defined reason for discontinuation, which ever comes first.
Interventions
DRUGDTG 50 mg
DTG is available as 50 mg film-coated tablet. DTG may be administered with or without food
DRUGEFV 600 mg
EFV is supplied as film-coated capsule-shaped oral tablet containing 600 mg of EFV and must be administered without food
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject or the subject's legal representative is willing and able to understand and provide signed and dated written informed consent prior to Screening * Adult subject (at least 18 years of age) with plasma HIV-1 RNA\>=1000 copies/ milliliter (mL) at Screening * CD4+ cell count is \>= 50 cells/ cubic millimetre (mm\^3) at Screening * HIV-1-infected, ART-naïve; (\<=10 days of prior therapy with any antiretroviral drug following a diagnosis of HIV-1 infection) * A female subject may be eligible to enter and participate in the study if she: is of non-childbearing potential defined as either postmenopausal (12 months of spontaneous amenorrhea and \>=45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy, or bilateral oophorectomy or, is of childbearing potential, with a negative pregnancy test at both Screening and Day 1, and agrees to use one of the following methods of contraception to avoid pregnancy * Complete abstinence from intercourse from 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after discontinuation of all study medications * Double-barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide) * Approved hormonal contraception plus a barrier method while receiving Rifampicin (RIF)-containing TB treatment for subjects randomly assigned to the DTG arm or approved hormonal contraception plus a barrier method for subjects randomly assigned to the EFV arm (regardless of RIF-containing TB treatment) * Any intrauterine device with published data showing that the expected failure rate is \<1% per year * Male partner sterilization prior to the female subject's entry into the study and this male is the sole partner for that subject * Any other method with published data showing that the expected failure rate is \<1% per year * Any contraception method must be used consistently, in accordance with the approved product label and for at least 2 weeks after discontinuation of study drug. A childbearing potential female subject who starts the study using complete abstinence as her contraceptive method and decides to become sexually active must use the double barrier method either as a bridge to an approved hormonal contraception (if possible) or as a method of choice to be maintained from that moment onwards * All subjects participating in the study should be counseled on safer sexual practices including the use of effective barrier methods * New diagnosis of pulmonary, pleural, or Lymph node (LN) TB based on identification of Mycobacterium tuberculosis using culture methods or validated nucleic acid amplification test on sputum or on samples collected by needle aspirate of pleural fluid or an affected LN * RIF sensitivity of Mycobacterium tuberculosis either by culture or validated nucleic acid amplification test * RIF-containing first-line TB treatment or an alternate RIF-containing TB treatment started up to a maximum of 8 weeks before randomization and no later than the screening date * Karnofsky score \>=70% before randomization
Exclusion criteria
* Any previous TB treatment (not including treatment for latent disease) * Evidence of RIF resistance of Mycobacterium tuberculosis either by culture or validated nucleic acid amplification test * Expected requirement for TB treatment \>9 months * Concomitant disorders or conditions for which isoniazid, RIF, pyrazinamide, or ethambutol are contraindicated * Central nervous system, miliary, or pericardial TB * Women who are pregnant or breastfeeding * Any evidence of an active Acquired immunodeficiency syndrome (AIDS)-defining disease (Centers for Disease Control and Prevention, Category C). Exceptions include TB, cutaneous Kaposi's sarcoma not requiring systemic therapy, and historic CD4+ cell counts of \<200 cells/mm\^3 * Subjects with moderate to severe hepatic impairment (Class B or C) as determined by Child-Pugh classification unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, or known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) * Subjects positive for hepatitis B surface antigen (HBsAg) at screening * Anticipated need for hepatitis C virus (HCV) therapy during the Randomized Phase of the study * 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, resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the study medical monitor for inclusion of the subject * Subjects who, in the investigator's judgment, pose a significant suicidality risk. Recent history of suicidal behavior 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 immunomodulators that alter immune response * Treatment with any agent, other than licensed ART as allowed above with documented activity against HIV-1 in vitro/vivo within 28 days of first dose of IP * 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 IP * Any evidence of primary viral resistance to Nucleoside reverse transcriptase inhibitor (NRTIs), Non-nucleoside reverse transcriptase inhibitor (NNRTIs), or Protease inhibitor (PIs) based on the presence of any major resistance-associated mutation (according to the International AIDS Society Update of the Drug Resistant Mutations in HIV-1 ) in the Screening result or, if known, any historical resistance test result. Note: Retests of Screening genotypes are not allowed * Any verified Grade 4 laboratory abnormality * Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the subject's participation in the study of an investigational compound * Alanine aminotransferase \>=2 × upper limit of normal * Hemoglobin \<=7.4 grams per deciliter; * Platelet count \<50000/mm\^3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Plasma Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/Milliliter at Week 48 in DTG Arm Using the Modified United States (US) Food and Drug Administration (FDA) Snapshot Algorithm | Week 48 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with plasma HIV-1 RNA \<50 copies/milliliter was assessed at Week 48 using the snapshot algorithm in the DTG arm. Response was assessed using a modified FDA Snapshot algorithm in which participants were not penalized for any single protocol allowed background therapy substitution even if occurs after the first trial visit. In this approach participants with HIV-1 RNA \>=50 copies/milliliter are considered as non-responders. Participants without HIV-1 RNA data at Week 48 (due to missing data or discontinuation of investigational product \[IP\] prior to visit window) are also considered as non-responders, as well as participants with anti-retroviral (ART) substitutions were not permitted. Study drug (i.e. DTG or EFV) was not allowed to be substituted. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA <50 Copies/Milliliter at Week 24 in Both EFV and DTG Arms Using the Modified Snapshot Algorithm | Week 24 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with plasma HIV-1 RNA \<50 copies/milliliter were assessed at Week 24 using the snapshot algorithm in the DTG and EFV arm. Response was assessed according to the Modified Snapshot algorithm. In this approach participants with HIV-1 RNA \>=50 copies/milliliter were considered non-responders. Participants without HIV-1 RNA data at Week 24 (due to missing data or discontinuation of IP prior to visit window) were also considered as non-responders, as well as participants with ART substitutions were not permitted. Substitution of a background NRTI agent was permissible one time if it was due to reasons of drug toxicity. |
| Percentage of Participants Without Confirmed Virologic Withdrawal and Without Discontinuation Due to Treatment-related Reasons at Week 24 and Week 48 | Week 24 and Week 48 | Percentage of participants not meeting confirmed virologic withdrawal criteria nor discontinued due to treatment related reasons at the time of analysis at Week 24 (through Day 210) and Week 48 (through Day 350) has been presented by treatment group. The time to meeting confirmed virologic withdrawal criteria or discontinuation due to treatment related reasons (i.e., discontinuation due to drug-related adverse event \[AE\], or due to protocol defined safety stopping criteria, or due to lack of efficacy) were calculated. Participants who met confirmed virologic withdrawal criteria or discontinuation due to treatment related reasons were considered as Failure. Participants who had not met confirmed virologic withdrawal criteria (per protocol) and were ongoing in the study, or who had discontinued for reasons other than those related to treatment, were censored. This would be the Treatment-Related Discontinuation = Failure (TRDF) data. |
| Change From Baseline in Cluster of Differentiation 4 (CD4+) Counts at Week 24 and Week 48 | Baseline (Day 1), Week 24 and Week 48 | Blood samples were collected for assessment of lymphocyte subsets (CD4+ lymphocyte count) by flow cytometry at Baseline and Weeks 24, 48. Baseline was defined as the last pre-treatment value observed (typically from Day 1 visit). Change from Baseline was calculated subtracting the value at the specified time point from the Baseline value. |
| Number of Participants With Serious Adverse Event (SAE) and Common (>=5%) Non-serious AE (Non-SAE) - Randomized Phase | Up to Week 52 | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, all events of possible drug-induced liver injury with hyperbilirubinemia or any other situation according to medical or scientific judgment. Data for number of participants with SAE and common (\>=5%) non-SAE over 52 weeks has been summarized. |
| Number of Participants With SAE and Common (>=5%) Non-SAE - OLE Phase | Week 52 to Week 252 | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, all events of possible drug-induced liver injury with hyperbilirubinemia or any other situation according to medical or scientific judgment. Data for number of participants with SAE and common (\>=5%) non-SAE from Week 52 to Week 252 has been summarized. |
| Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Up to Week 52 | Blood samples for assessment of clinical chemistry parameters were collected at indicated time points. Clinical chemistry assessments included alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, glucose, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphate, potassium, and sodium. Data for number of participants who experienced maximum post-Baseline emergent chemistry toxicities were summarized. Maximum post-Baseline emergent chemistry toxicities were graded using Division of Acquired Immune Deficiency Syndrome (DAIDS) toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating). Higher grade indicates more severity. |
| Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Up to Week 252 | Blood samples for assessment of clinical chemistry parameters were collected at indicated time points. Clinical chemistry assessments included ALT, albumin, alkaline phosphatase, AST, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, glucose, LDL cholesterol calculation, lipase, phosphate, potassium, and sodium. Data for number of participants with maximum post-Baseline emergent chemistry toxicities were summarized. Maximum post-Baseline emergent chemistry toxicities were graded using DAIDS toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating) . Higher grade indicates more severity. |
| Percentage of Participants Who Permanently Discontinued Study Treatment Due to AEs - Randomized Phase | Up to Week 52 | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Data for percentage of participants who permanently discontinued study treatment due to any AE over 52 weeks has been summarized. |
| Percentage of Participants With Plasma HIV-1 RNA <50 Copies/Milliliter at Week 48 in EFV Arm Using the Modified Snapshot Algorithm | Week 48 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with plasma HIV-1 RNA \<50 copies/milliliter were assessed at Week 48 using the snapshot algorithm in the EFV arm. Response was assessed using a modified FDA Snapshot algorithm in which participants were not penalized for any single protocol allowed background therapy substitution even if occurs after the first trial visit. In this approach participants with HIV-1 RNA \>=50 copies/milliliter are considered as non-responders. Participants without HIV-1 RNA data at Week 48 (due to missing data or discontinuation of IP prior to visit window) are also considered as non-responders, as well as participants with ART substitutions were not permitted. Study drug (i.e. DTG or EFV) was not allowed to be substituted. |
| Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Up to Week 252 | Blood samples for assessment of hematology parameters were collected at indicated time points. Hematology assessments included hemoglobin, leukocytes, neutrophils and platelets. Data for number of participants who experienced maximum post-Baseline emergent hematology toxicities were summarized. Maximum post-Baseline emergent hematology toxicities were graded using DAIDS toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating). Higher grade indicates more severity. |
| Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 | Baseline (Day 1), Week 24 and Week 48 | Samples for lipid measurements were obtained in a fasted state at Baseline, Week 24 and Week 48. The parameters assessed during the lipid profile were total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, triglycerides. Baseline was defined as the last pre-treatment value observed (typically from Day 1 visit). Percent change from Baseline for a parameter was calculated as the observed value minus the Baseline value divided by Baseline value multiplied by 100. Data for fasting lipid parameters has been summarized. |
| Change From Baseline in the Fasting Lipid Profile for Total Cholesterol/HDL Ratio at Week 24 and Week 48 | Baseline (Day 1), Week 24 and Week 48 | Samples for lipid measurements were obtained in a fasted state at Baseline, Week 24 and Week 48. The parameter assessed during the lipid profile was total cholesterol/HDL ratio. Baseline was defined as the last pre-treatment value observed (typically from Day 1 visit). Change from baseline for a parameter was calculated as the observed value minus the Baseline value. |
| Percentage of Participants Who Permanently Discontinued Study Treatment Due to AEs - OLE Phase | Week 52 to Week 252 | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Data for percentage of participants who permanently discontinued study treatment due to any AE from Week 52 to Week 252 has been summarized. |
| Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Up to Week 12 | Participants were monitored for signs and symptoms of TB-assoc. IRIS. Participants with IRIS symptoms in any AE or HIV assoc. conditions were classified by Endpoint Adjudication Committee in following four categories: met criteria for TB-assoc. IRIS, possibly met criteria for TB-assoc. IRIS, suspected TB-assoc. IRIS but not possible to adjudicate and No TB associated IRIS. They were further graded from Grades 1 to 4 using DAIDS. Higher grade indicates more severity. The preliminary requirements to meet TB-assoc. IRIS criteria were diagnosis of TB and initial response to TB treatment (stabilized or improved condition of participant in presence of TB treatment before starting ART). The clinical criteria was onset of IRIS signs and symptoms related to TB should occur within first 3 months of starting, restarting or changing ART regimen for treatment failure. Number of participants who sent to the adjudication committee and analyzed were presented. |
| Number of Participants With Treatment-emergent Genotypic Resistance | Up to Week 52 | Whole venous blood samples were obtained from each participant until Week 52 for potential viral genotypic and phenotypic analyses. Genotypic and phenotypic testing was conducted for participants meeting confirmed virologic withdrawal criteria, i.e., confirmed HIV-1 RNA \>=400 copies/milliliter from Week 24 onwards. Genotypic and phenotypic analyses was carried out by Monogram Biosciences using, but not limited to, their Standard Phenosense and GenoSure testing methods for protease (PRO), reverse transcriptase (RT), and integrase assays. Data for number of participants with treatment-emergent genotypic resistance mutations have been presented for the RT region on codons G190G, K101K, K103K, K65K, V106V and Y181Y. |
| Number of Participants With Treatment-emergent Phenotypic Resistance | Up to Week 52 | Phenotypic susceptibility to all licensed antiretroviral drugs, including DTG and EFV were determined using PhenoSense HIV assays from Monogram Inc. Clinical cutoffs or biological cutoffs by PhenoSense were used to define the phenotypic susceptibility of background treatment and were interpreted as fold change \> clinical lower cut-off or biologic cut-off as resistance, fold change \<=clinical lower cut-off or biologic cut-off as sensitive, and fold change \> clinical higher cut-off as resistance, fold change \<=clinical higher cut-off and \> clinical lower cut-off as partially sensitive, and fold change \<=clinical lower cut-off as sensitive. Data has been presented for participants with treatment-emergent phenotypic resistance. |
| Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Up to Week 52 | Blood samples for assessment of hematology parameters were collected at indicated time points. Hematology assessments included hemoglobin, leukocytes, neutrophils and platelets. Data for number of participants who experienced maximum post-Baseline emergent hematology toxicities were summarized. Maximum post-Baseline emergent hematology toxicities were graded using DAIDS toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating). Higher grade indicates more severity. |
Countries
Argentina, Brazil, Mexico, Peru, Russia, South Africa, Thailand
Participant flow
Recruitment details
This study was conducted in 7 countries across 25 centers; Argentina (2), Brazil (4), Mexico (3), Peru (4), Russia (2), South Africa (8) and Thailand (2). Participants were randomized to receive either Dolutegravir (DTG) or Efavirenz (EFV) containing regimens.
Pre-assignment details
A total of 263 participants were screened of which 150 were screen failures. A total of 113 participants were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| DTG 50 mg Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252). | 69 |
| EFV 600 mg Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV. | 44 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| OLE Phase (Week 52 to Week 252) | Adverse Event | 1 | 0 |
| OLE Phase (Week 52 to Week 252) | Lack of Efficacy | 0 | 1 |
| OLE Phase (Week 52 to Week 252) | Lost to Follow-up | 3 | 1 |
| OLE Phase (Week 52 to Week 252) | Protocol Violation | 2 | 0 |
| OLE Phase (Week 52 to Week 252) | Reached Protocol defined stopping criteria | 2 | 0 |
| OLE Phase (Week 52 to Week 252) | Withdrawal by Subject | 4 | 1 |
| Randomized Phase (Up to Week 52) | Adverse Event | 0 | 2 |
| Randomized Phase (Up to Week 52) | Lack of Efficacy | 1 | 1 |
| Randomized Phase (Up to Week 52) | Lost to Follow-up | 11 | 3 |
| Randomized Phase (Up to Week 52) | Physician Decision | 1 | 0 |
| Randomized Phase (Up to Week 52) | Protocol Violation | 3 | 2 |
| Randomized Phase (Up to Week 52) | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | EFV 600 mg | Total | DTG 50 mg |
|---|---|---|---|
| Age, Continuous | 33.1 Years STANDARD_DEVIATION 7.56 | 34.0 Years STANDARD_DEVIATION 9.29 | 34.6 Years STANDARD_DEVIATION 10.25 |
| Race/Ethnicity, Customized African American/African Heritage | 28 Participants | 75 Participants | 47 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Participants | 15 Participants | 11 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Mixed Race | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 9 Participants | 18 Participants | 9 Participants |
| Sex: Female, Male Female | 16 Participants | 46 Participants | 30 Participants |
| Sex: Female, Male Male | 28 Participants | 67 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 69 | 0 / 44 | 1 / 47 | 0 / 19 |
| other Total, other adverse events | 38 / 69 | 33 / 44 | 36 / 47 | 16 / 19 |
| serious Total, serious adverse events | 5 / 69 | 5 / 44 | 5 / 47 | 2 / 19 |
Outcome results
Primary
Percentage of Participants With Plasma Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/Milliliter at Week 48 in DTG Arm Using the Modified United States (US) Food and Drug Administration (FDA) Snapshot Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with plasma HIV-1 RNA \<50 copies/milliliter was assessed at Week 48 using the snapshot algorithm in the DTG arm. Response was assessed using a modified FDA Snapshot algorithm in which participants were not penalized for any single protocol allowed background therapy substitution even if occurs after the first trial visit. In this approach participants with HIV-1 RNA \>=50 copies/milliliter are considered as non-responders. Participants without HIV-1 RNA data at Week 48 (due to missing data or discontinuation of investigational product \[IP\] prior to visit window) are also considered as non-responders, as well as participants with anti-retroviral (ART) substitutions were not permitted. Study drug (i.e. DTG or EFV) was not allowed to be substituted.
Time frame: Week 48
Population: Intent-to-treat exposed (ITT-E) Population comprised of all randomly assigned participants who received at least one dose of IP.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTG 50 mg | Percentage of Participants With Plasma Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/Milliliter at Week 48 in DTG Arm Using the Modified United States (US) Food and Drug Administration (FDA) Snapshot Algorithm | 75 Percentage of participants |
Secondary
Change From Baseline in Cluster of Differentiation 4 (CD4+) Counts at Week 24 and Week 48
Blood samples were collected for assessment of lymphocyte subsets (CD4+ lymphocyte count) by flow cytometry at Baseline and Weeks 24, 48. Baseline was defined as the last pre-treatment value observed (typically from Day 1 visit). Change from Baseline was calculated subtracting the value at the specified time point from the Baseline value.
Time frame: Baseline (Day 1), Week 24 and Week 48
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg | Change From Baseline in Cluster of Differentiation 4 (CD4+) Counts at Week 24 and Week 48 | Week 24, n=61,41 | 153.2 Cells per millimeter^3 | Standard Deviation 125.09 |
| DTG 50 mg | Change From Baseline in Cluster of Differentiation 4 (CD4+) Counts at Week 24 and Week 48 | Week 48, n=49, 33 | 199.0 Cells per millimeter^3 | Standard Deviation 146.22 |
| EFV 600 mg | Change From Baseline in Cluster of Differentiation 4 (CD4+) Counts at Week 24 and Week 48 | Week 24, n=61,41 | 127.1 Cells per millimeter^3 | Standard Deviation 158.14 |
| EFV 600 mg | Change From Baseline in Cluster of Differentiation 4 (CD4+) Counts at Week 24 and Week 48 | Week 48, n=49, 33 | 194.5 Cells per millimeter^3 | Standard Deviation 137.81 |
Secondary
Change From Baseline in the Fasting Lipid Profile for Total Cholesterol/HDL Ratio at Week 24 and Week 48
Samples for lipid measurements were obtained in a fasted state at Baseline, Week 24 and Week 48. The parameter assessed during the lipid profile was total cholesterol/HDL ratio. Baseline was defined as the last pre-treatment value observed (typically from Day 1 visit). Change from baseline for a parameter was calculated as the observed value minus the Baseline value.
Time frame: Baseline (Day 1), Week 24 and Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented as n=X in the category titles). Data for this outcome measure has been presented until Week 48 only (Randomized Phase) as per protocol. It was not planned for OLE Phase, hence data was not collected for OLE Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg | Change From Baseline in the Fasting Lipid Profile for Total Cholesterol/HDL Ratio at Week 24 and Week 48 | Total cholesterol/HDL ratio, Week 24, n=58, 40 | -16.292 Ratio of total cholesterol to HDL | Standard Deviation 22.7982 |
| DTG 50 mg | Change From Baseline in the Fasting Lipid Profile for Total Cholesterol/HDL Ratio at Week 24 and Week 48 | Total cholesterol/HDL ratio, Week 48, n=47, 34 | -11.949 Ratio of total cholesterol to HDL | Standard Deviation 27.5044 |
| EFV 600 mg | Change From Baseline in the Fasting Lipid Profile for Total Cholesterol/HDL Ratio at Week 24 and Week 48 | Total cholesterol/HDL ratio, Week 24, n=58, 40 | 36.562 Ratio of total cholesterol to HDL | Standard Deviation 315.0478 |
| EFV 600 mg | Change From Baseline in the Fasting Lipid Profile for Total Cholesterol/HDL Ratio at Week 24 and Week 48 | Total cholesterol/HDL ratio, Week 48, n=47, 34 | -11.051 Ratio of total cholesterol to HDL | Standard Deviation 28.3183 |
Secondary
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase
Blood samples for assessment of clinical chemistry parameters were collected at indicated time points. Clinical chemistry assessments included alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, glucose, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphate, potassium, and sodium. Data for number of participants who experienced maximum post-Baseline emergent chemistry toxicities were summarized. Maximum post-Baseline emergent chemistry toxicities were graded using Division of Acquired Immune Deficiency Syndrome (DAIDS) toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating). Higher grade indicates more severity.
Time frame: Up to Week 52
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Creatine kinase, Grade 1 | 3 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Albumin, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Creatine kinase, Grade 2 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | AST, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Creatine kinase, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Sodium, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Creatine kinase, Grade 4 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | AST, Grade 4 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Creatinine, Grade 1 | 2 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Albumin, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Creatinine, Grade 2 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Bilirubin, Grade 1 | 3 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Creatinine, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | ALT, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Creatinine, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Bilirubin, Grade 2 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Glucose, Grade 1 | 11 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Alkaline phosphatase, Grade 1 | 7 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Glucose, Grade 2 | 3 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Bilirubin, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Glucose, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | ALT, Grade 2 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Glucose, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Bilirubin, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | LDL cholesterol calculation, Grade 1 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Alkaline phosphatase, Grade 2 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | LDL cholesterol calculation, Grade 2 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Carbon dioxide, Grade 1 | 14 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | LDL cholesterol calculation, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Albumin, Grade 1 | 2 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | LDL cholesterol calculation, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Carbon dioxide, Grade 2 | 4 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Lipase, Grade 1 | 2 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Alkaline phosphatase, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Lipase, Grade 2 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Carbon dioxide, Grade 3 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Lipase, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | ALT, Grade 1 | 10 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Lipase, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Carbon dioxide, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Phosphate, Grade 1 | 5 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Alkaline phosphatase, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Phosphate, Grade 2 | 3 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Cholesterol, Grade 1 | 5 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Phosphate, Grade 3 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Albumin, Grade 2 | 8 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Phosphate, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Cholesterol, Grade 2 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Potassium, Grade 1 | 5 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | AST, Grade 1 | 11 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Potassium, Grade 2 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Cholesterol, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Potassium, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | ALT, Grade 3 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Potassium, Grade 4 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Cholesterol, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Sodium, Grade 1 | 17 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | AST, Grade 2 | 4 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Sodium, Grade 2 | 2 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Sodium, Grade 3 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Sodium, Grade 2 | 3 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Sodium, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Sodium, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | ALT, Grade 1 | 9 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | ALT, Grade 2 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | ALT, Grade 3 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | ALT, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Albumin, Grade 1 | 2 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Albumin, Grade 2 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Albumin, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Albumin, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Alkaline phosphatase, Grade 1 | 11 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Alkaline phosphatase, Grade 2 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Alkaline phosphatase, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Alkaline phosphatase, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | AST, Grade 1 | 8 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | AST, Grade 2 | 3 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | AST, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | AST, Grade 4 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Bilirubin, Grade 1 | 3 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Bilirubin, Grade 2 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Bilirubin, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Bilirubin, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Carbon dioxide, Grade 1 | 8 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Carbon dioxide, Grade 2 | 4 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Carbon dioxide, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Carbon dioxide, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Cholesterol, Grade 1 | 6 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Cholesterol, Grade 2 | 2 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Cholesterol, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Cholesterol, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Creatine kinase, Grade 1 | 4 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Creatine kinase, Grade 2 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Creatine kinase, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Creatine kinase, Grade 4 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Creatinine, Grade 1 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Creatinine, Grade 2 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Creatinine, Grade 3 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Creatinine, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Glucose, Grade 1 | 10 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Glucose, Grade 2 | 5 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Glucose, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Glucose, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | LDL cholesterol calculation, Grade 1 | 3 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | LDL cholesterol calculation, Grade 2 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | LDL cholesterol calculation, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | LDL cholesterol calculation, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Lipase, Grade 1 | 2 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Lipase, Grade 2 | 2 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Lipase, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Lipase, Grade 4 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Phosphate, Grade 1 | 3 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Phosphate, Grade 2 | 5 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Phosphate, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Phosphate, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Potassium, Grade 1 | 3 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Potassium, Grade 2 | 2 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Potassium, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Potassium, Grade 4 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase | Sodium, Grade 1 | 9 Participants |
Secondary
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase
Blood samples for assessment of clinical chemistry parameters were collected at indicated time points. Clinical chemistry assessments included ALT, albumin, alkaline phosphatase, AST, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, glucose, LDL cholesterol calculation, lipase, phosphate, potassium, and sodium. Data for number of participants with maximum post-Baseline emergent chemistry toxicities were summarized. Maximum post-Baseline emergent chemistry toxicities were graded using DAIDS toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating) . Higher grade indicates more severity.
Time frame: Up to Week 252
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | LDL cholesterol calculation, Grade 2 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Bilirubin, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | LDL cholesterol calculation, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Cholesterol, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | LDL cholesterol calculation, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | AST, Grade 1 | 14 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Lipase, Grade 1 | 3 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Creatine kinase, Grade 1 | 7 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Lipase, Grade 2 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Carbon dioxide, Grade 1 | 16 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Lipase, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Creatine kinase, Grade 2 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Lipase, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Bilirubin, Grade 1 | 7 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Phosphate, Grade 1 | 5 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Creatine kinase, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Phosphate, Grade 2 | 10 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Carbon dioxide, Grade 2 | 5 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Phosphate, Grade 3 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Creatine kinase, Grade 4 | 2 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Phosphate, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | AST, Grade 3 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Potassium, Grade 1 | 8 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Creatinine, Grade 1 | 2 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Potassium, Grade 2 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Carbon dioxide, Grade 3 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Potassium, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Creatinine, Grade 2 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Potassium, Grade 4 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Bilirubin, Grade 2 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Sodium, Grade 1 | 22 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Creatinine, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Sodium, Grade 2 | 3 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Carbon dioxide, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Sodium, Grade 3 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Creatinine, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Sodium, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | AST, Grade 2 | 6 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | ALT, Grade 1 | 12 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Glucose, Grade 1 | 12 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | ALT, Grade 2 | 3 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Cholesterol, Grade 1 | 5 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | ALT, Grade 3 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Glucose, Grade 2 | 7 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | ALT, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Bilirubin, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Albumin, Grade 1 | 2 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Glucose, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Albumin, Grade 2 | 8 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Cholesterol, Grade 2 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Albumin, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Glucose, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Albumin, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | AST, Grade 4 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Alkaline phosphatase, Grade 1 | 8 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | LDL cholesterol calculation, Grade 1 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Alkaline phosphatase, Grade 2 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Cholesterol, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Alkaline phosphatase, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Alkaline phosphatase, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Alkaline phosphatase, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Alkaline phosphatase, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | AST, Grade 1 | 8 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | AST, Grade 2 | 3 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | AST, Grade 3 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | AST, Grade 4 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Bilirubin, Grade 1 | 3 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Bilirubin, Grade 2 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Bilirubin, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Bilirubin, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Carbon dioxide, Grade 1 | 10 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Carbon dioxide, Grade 2 | 4 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Carbon dioxide, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Carbon dioxide, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Cholesterol, Grade 1 | 6 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Cholesterol, Grade 2 | 2 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Cholesterol, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Cholesterol, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Creatine kinase, Grade 1 | 4 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Creatine kinase, Grade 2 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Creatine kinase, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Creatine kinase, Grade 4 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Creatinine, Grade 1 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Creatinine, Grade 2 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Creatinine, Grade 3 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Creatinine, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Glucose, Grade 1 | 12 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Glucose, Grade 2 | 5 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Glucose, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Glucose, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | LDL cholesterol calculation, Grade 1 | 3 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | LDL cholesterol calculation, Grade 2 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | LDL cholesterol calculation, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | LDL cholesterol calculation, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Lipase, Grade 1 | 2 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Lipase, Grade 2 | 3 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Lipase, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Lipase, Grade 4 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Phosphate, Grade 1 | 5 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Phosphate, Grade 2 | 7 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Phosphate, Grade 3 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Phosphate, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Potassium, Grade 1 | 3 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Potassium, Grade 2 | 2 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Potassium, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Potassium, Grade 4 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Sodium, Grade 1 | 9 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Sodium, Grade 2 | 3 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Sodium, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Sodium, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | ALT, Grade 1 | 10 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | ALT, Grade 2 | 2 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | ALT, Grade 3 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | ALT, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Albumin, Grade 1 | 2 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Albumin, Grade 2 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Albumin, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Albumin, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Alkaline phosphatase, Grade 1 | 12 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase | Alkaline phosphatase, Grade 2 | 1 Participants |
Secondary
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase
Blood samples for assessment of hematology parameters were collected at indicated time points. Hematology assessments included hemoglobin, leukocytes, neutrophils and platelets. Data for number of participants who experienced maximum post-Baseline emergent hematology toxicities were summarized. Maximum post-Baseline emergent hematology toxicities were graded using DAIDS toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating). Higher grade indicates more severity.
Time frame: Up to Week 52
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Hemoglobin, Grade 1 | 2 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Hemoglobin, Grade 2 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Hemoglobin, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Hemoglobin, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Leukocytes, Grade 1 | 4 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Leukocytes, Grade 2 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Leukocytes, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Leukocytes, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Neutrophils, Grade 1 | 6 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Neutrophils, Grade 2 | 2 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Neutrophils, Grade 3 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Neutrophils, Grade 4 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Platelets, Grade 1 | 2 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Platelets, Grade 2 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Platelets, Grade 3 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Platelets, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Platelets, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Hemoglobin, Grade 1 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Neutrophils, Grade 1 | 3 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Hemoglobin, Grade 2 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Platelets, Grade 1 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Hemoglobin, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Neutrophils, Grade 2 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Hemoglobin, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Platelets, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Leukocytes, Grade 1 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Neutrophils, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Leukocytes, Grade 2 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Platelets, Grade 2 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Leukocytes, Grade 3 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Neutrophils, Grade 4 | 2 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase | Leukocytes, Grade 4 | 1 Participants |
Secondary
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase
Blood samples for assessment of hematology parameters were collected at indicated time points. Hematology assessments included hemoglobin, leukocytes, neutrophils and platelets. Data for number of participants who experienced maximum post-Baseline emergent hematology toxicities were summarized. Maximum post-Baseline emergent hematology toxicities were graded using DAIDS toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating). Higher grade indicates more severity.
Time frame: Up to Week 252
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Hemoglobin, Grade 1 | 2 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Hemoglobin, Grade 2 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Hemoglobin, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Hemoglobin, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Leukocytes, Grade 1 | 5 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Leukocytes, Grade 2 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Leukocytes, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Leukocytes, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Neutrophils, Grade 1 | 4 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Neutrophils, Grade 2 | 5 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Neutrophils, Grade 3 | 2 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Neutrophils, Grade 4 | 2 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Platelets, Grade 1 | 0 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Platelets, Grade 2 | 1 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Platelets, Grade 3 | 2 Participants |
| DTG 50 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Platelets, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Platelets, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Hemoglobin, Grade 1 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Neutrophils, Grade 1 | 2 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Hemoglobin, Grade 2 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Platelets, Grade 1 | 2 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Hemoglobin, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Neutrophils, Grade 2 | 3 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Hemoglobin, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Platelets, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Leukocytes, Grade 1 | 3 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Neutrophils, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Leukocytes, Grade 2 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Platelets, Grade 2 | 0 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Leukocytes, Grade 3 | 1 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Neutrophils, Grade 4 | 3 Participants |
| EFV 600 mg | Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase | Leukocytes, Grade 4 | 1 Participants |
Secondary
Number of Participants With SAE and Common (>=5%) Non-SAE - OLE Phase
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, all events of possible drug-induced liver injury with hyperbilirubinemia or any other situation according to medical or scientific judgment. Data for number of participants with SAE and common (\>=5%) non-SAE from Week 52 to Week 252 has been summarized.
Time frame: Week 52 to Week 252
Population: Safety OLE Population comprised of all participants in Safety Population who entered the OLE phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg | Number of Participants With SAE and Common (>=5%) Non-SAE - OLE Phase | Common Non-SAE | 36 Participants |
| DTG 50 mg | Number of Participants With SAE and Common (>=5%) Non-SAE - OLE Phase | SAE | 5 Participants |
| EFV 600 mg | Number of Participants With SAE and Common (>=5%) Non-SAE - OLE Phase | Common Non-SAE | 16 Participants |
| EFV 600 mg | Number of Participants With SAE and Common (>=5%) Non-SAE - OLE Phase | SAE | 2 Participants |
Secondary
Number of Participants With Serious Adverse Event (SAE) and Common (>=5%) Non-serious AE (Non-SAE) - Randomized Phase
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, all events of possible drug-induced liver injury with hyperbilirubinemia or any other situation according to medical or scientific judgment. Data for number of participants with SAE and common (\>=5%) non-SAE over 52 weeks has been summarized.
Time frame: Up to Week 52
Population: Safety Population comprised of all participants who received at least one dose of IP.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg | Number of Participants With Serious Adverse Event (SAE) and Common (>=5%) Non-serious AE (Non-SAE) - Randomized Phase | Common Non-SAE | 38 Participants |
| DTG 50 mg | Number of Participants With Serious Adverse Event (SAE) and Common (>=5%) Non-serious AE (Non-SAE) - Randomized Phase | SAE | 5 Participants |
| EFV 600 mg | Number of Participants With Serious Adverse Event (SAE) and Common (>=5%) Non-serious AE (Non-SAE) - Randomized Phase | Common Non-SAE | 33 Participants |
| EFV 600 mg | Number of Participants With Serious Adverse Event (SAE) and Common (>=5%) Non-serious AE (Non-SAE) - Randomized Phase | SAE | 5 Participants |
Secondary
Number of Participants With Treatment-emergent Genotypic Resistance
Whole venous blood samples were obtained from each participant until Week 52 for potential viral genotypic and phenotypic analyses. Genotypic and phenotypic testing was conducted for participants meeting confirmed virologic withdrawal criteria, i.e., confirmed HIV-1 RNA \>=400 copies/milliliter from Week 24 onwards. Genotypic and phenotypic analyses was carried out by Monogram Biosciences using, but not limited to, their Standard Phenosense and GenoSure testing methods for protease (PRO), reverse transcriptase (RT), and integrase assays. Data for number of participants with treatment-emergent genotypic resistance mutations have been presented for the RT region on codons G190G, K101K, K103K, K65K, V106V and Y181Y.
Time frame: Up to Week 52
Population: Viral Genotypic Population comprised of all participants in the ITT-E Population with available on-treatment genotypic data at the time confirmed virologic withdrawal was met.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg | Number of Participants With Treatment-emergent Genotypic Resistance | G190G (wild type) | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Genotypic Resistance | G190G/A | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Genotypic Resistance | K101K (wild type) | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Genotypic Resistance | K101K/E | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Genotypic Resistance | K103K (wild type) | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Genotypic Resistance | K103K/N | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Genotypic Resistance | K65K (wild type) | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Genotypic Resistance | K65R | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Genotypic Resistance | V106V (wild type) | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Genotypic Resistance | V106M | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Genotypic Resistance | Y181Y (wild type) | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Genotypic Resistance | Y181Y/C | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Genotypic Resistance | Y181Y (wild type) | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Genotypic Resistance | G190G (wild type) | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Genotypic Resistance | K65K (wild type) | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Genotypic Resistance | G190G/A | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Genotypic Resistance | V106M | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Genotypic Resistance | K101K (wild type) | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Genotypic Resistance | K65R | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Genotypic Resistance | K101K/E | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Genotypic Resistance | Y181Y/C | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Genotypic Resistance | K103K (wild type) | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Genotypic Resistance | V106V (wild type) | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Genotypic Resistance | K103K/N | 1 Participants |
Secondary
Number of Participants With Treatment-emergent Phenotypic Resistance
Phenotypic susceptibility to all licensed antiretroviral drugs, including DTG and EFV were determined using PhenoSense HIV assays from Monogram Inc. Clinical cutoffs or biological cutoffs by PhenoSense were used to define the phenotypic susceptibility of background treatment and were interpreted as fold change \> clinical lower cut-off or biologic cut-off as resistance, fold change \<=clinical lower cut-off or biologic cut-off as sensitive, and fold change \> clinical higher cut-off as resistance, fold change \<=clinical higher cut-off and \> clinical lower cut-off as partially sensitive, and fold change \<=clinical lower cut-off as sensitive. Data has been presented for participants with treatment-emergent phenotypic resistance.
Time frame: Up to Week 52
Population: Viral Phenotypic Population comprised of all participants in the ITT-E Population with available on-treatment phenotypic resistance data at the time confirmed virologic withdrawal criteria was met. Only 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 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Nevirapine, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Tenofovir, Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Delavirdine, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Tenofovir, Partially sensitive, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Rilpivirine, Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Tenofovir, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Dolutegravir, Partially sensitive, n=1,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Zidovudine, Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Rilpivirine, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Zidovudine, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Efavirenz, Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Atazanavir, Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Abacavir, Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Atazanavir, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Raltegravir, Sensitive, n=1,1 | 1 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Darunavir, Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Abacavir, Partially sensitive, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Darunavir, Partially sensitive, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Efavirenz, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Darunavir, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Abacavir, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Fosamprenavir, Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Elvitegravir, Sensitive, n=1,1 | 1 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Fosamprenavir, Partially sensitive, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Didanosine, Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Fosamprenavir, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Etravirine, Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Indinavir,Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Didanosine, Partially sensitive, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Indinavir, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Raltegravir, Resistance, n=1,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Lopinavir, Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Didanosine, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Lopinavir, Partially sensitive, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Etravirine, Partially sensitive, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Lopinavir, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Emtricitabine, Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Nelfinavir, Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Dolutegravir, Resistance, n=1,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Nelfinavir, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Emtricitabine, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Ritonavir, Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Etravirine, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Ritonavir, Partially sensitive, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Lamivudine, Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Ritonavir, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Delavirdine, Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Saquinavir, Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Lamivudine, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Saquinavir, Partially sensitive, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Nevirapine, Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Saquinavir, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Stavudine, Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Tipranavir, Sensitive, n=2,1 | 2 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Elvitegravir, Resistance, n=1,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Tipranavir, Partially sensitive, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Stavudine, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Tipranavir, Resistance, n=2,1 | 0 Participants |
| DTG 50 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Dolutegravir, Sensitive, n=1,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Tipranavir, Resistance, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Dolutegravir, Sensitive, n=1,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Dolutegravir, Partially sensitive, n=1,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Dolutegravir, Resistance, n=1,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Elvitegravir, Sensitive, n=1,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Elvitegravir, Resistance, n=1,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Raltegravir, Sensitive, n=1,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Raltegravir, Resistance, n=1,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Delavirdine, Sensitive, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Delavirdine, Resistance, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Efavirenz, Sensitive, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Efavirenz, Resistance, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Etravirine, Sensitive, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Etravirine, Partially sensitive, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Etravirine, Resistance, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Nevirapine, Sensitive, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Nevirapine, Resistance, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Rilpivirine, Sensitive, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Rilpivirine, Resistance, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Abacavir, Sensitive, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Abacavir, Partially sensitive, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Abacavir, Resistance, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Didanosine, Sensitive, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Didanosine, Partially sensitive, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Didanosine, Resistance, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Emtricitabine, Sensitive, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Emtricitabine, Resistance, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Lamivudine, Sensitive, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Lamivudine, Resistance, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Stavudine, Sensitive, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Stavudine, Resistance, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Tenofovir, Sensitive, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Tenofovir, Partially sensitive, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Tenofovir, Resistance, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Zidovudine, Sensitive, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Zidovudine, Resistance, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Atazanavir, Sensitive, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Atazanavir, Resistance, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Darunavir, Sensitive, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Darunavir, Partially sensitive, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Darunavir, Resistance, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Fosamprenavir, Sensitive, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Fosamprenavir, Partially sensitive, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Fosamprenavir, Resistance, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Indinavir,Sensitive, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Indinavir, Resistance, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Lopinavir, Sensitive, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Lopinavir, Partially sensitive, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Lopinavir, Resistance, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Nelfinavir, Sensitive, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Nelfinavir, Resistance, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Ritonavir, Sensitive, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Ritonavir, Partially sensitive, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Ritonavir, Resistance, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Saquinavir, Sensitive, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Saquinavir, Partially sensitive, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Saquinavir, Resistance, n=2,1 | 0 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Tipranavir, Sensitive, n=2,1 | 1 Participants |
| EFV 600 mg | Number of Participants With Treatment-emergent Phenotypic Resistance | Tipranavir, Partially sensitive, n=2,1 | 0 Participants |
Secondary
Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS)
Participants were monitored for signs and symptoms of TB-assoc. IRIS. Participants with IRIS symptoms in any AE or HIV assoc. conditions were classified by Endpoint Adjudication Committee in following four categories: met criteria for TB-assoc. IRIS, possibly met criteria for TB-assoc. IRIS, suspected TB-assoc. IRIS but not possible to adjudicate and No TB associated IRIS. They were further graded from Grades 1 to 4 using DAIDS. Higher grade indicates more severity. The preliminary requirements to meet TB-assoc. IRIS criteria were diagnosis of TB and initial response to TB treatment (stabilized or improved condition of participant in presence of TB treatment before starting ART). The clinical criteria was onset of IRIS signs and symptoms related to TB should occur within first 3 months of starting, restarting or changing ART regimen for treatment failure. Number of participants who sent to the adjudication committee and analyzed were presented.
Time frame: Up to Week 12
Population: Safety Population. Only those participants with data available at the specified time points were analyzed. Data for this outcome measure has been presented until Week 12 only (Randomized phase) as per protocol. It was not planned for OLE Phase, hence data was not collected for OLE Phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTG 50 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Met criteria for TB-assoc. IRIS, Grade 3 | 1 Participants |
| DTG 50 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Possibly met criteria for TB-assoc. IRIS, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Possibly met criteria for TB-assoc. IRIS, Grade 1 | 0 Participants |
| DTG 50 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Suspected TB-assoc. IRIS unable to adjudicate, Grade 1 | 0 Participants |
| DTG 50 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Met criteria for TB-assoc. IRIS, Grade 2 | 2 Participants |
| DTG 50 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Suspected TB-assoc. IRIS unable to adjudicate, Grade 2 | 0 Participants |
| DTG 50 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Possibly met criteria for TB-assoc. IRIS, Grade 2 | 0 Participants |
| DTG 50 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Suspected TB-assoc. IRIS unable to adjudicate, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Met criteria for TB-assoc. IRIS, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Suspected TB-assoc. IRIS unable to adjudicate, Grade 4 | 0 Participants |
| DTG 50 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Possibly met criteria for TB-assoc. IRIS, Grade 3 | 0 Participants |
| DTG 50 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | No TB associated IRIS | 5 Participants |
| DTG 50 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Met criteria for TB-assoc. IRIS, Grade 1 | 1 Participants |
| EFV 600 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | No TB associated IRIS | 8 Participants |
| EFV 600 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Met criteria for TB-assoc. IRIS, Grade 1 | 0 Participants |
| EFV 600 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Met criteria for TB-assoc. IRIS, Grade 2 | 3 Participants |
| EFV 600 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Met criteria for TB-assoc. IRIS, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Met criteria for TB-assoc. IRIS, Grade 4 | 1 Participants |
| EFV 600 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Possibly met criteria for TB-assoc. IRIS, Grade 1 | 0 Participants |
| EFV 600 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Possibly met criteria for TB-assoc. IRIS, Grade 2 | 0 Participants |
| EFV 600 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Possibly met criteria for TB-assoc. IRIS, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Possibly met criteria for TB-assoc. IRIS, Grade 4 | 0 Participants |
| EFV 600 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Suspected TB-assoc. IRIS unable to adjudicate, Grade 1 | 0 Participants |
| EFV 600 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Suspected TB-assoc. IRIS unable to adjudicate, Grade 2 | 0 Participants |
| EFV 600 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Suspected TB-assoc. IRIS unable to adjudicate, Grade 3 | 0 Participants |
| EFV 600 mg | Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) | Suspected TB-assoc. IRIS unable to adjudicate, Grade 4 | 0 Participants |
Secondary
Percentage of Participants Who Permanently Discontinued Study Treatment Due to AEs - OLE Phase
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Data for percentage of participants who permanently discontinued study treatment due to any AE from Week 52 to Week 252 has been summarized.
Time frame: Week 52 to Week 252
Population: Safety OLE Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTG 50 mg | Percentage of Participants Who Permanently Discontinued Study Treatment Due to AEs - OLE Phase | 4 Percentage of participants |
| EFV 600 mg | Percentage of Participants Who Permanently Discontinued Study Treatment Due to AEs - OLE Phase | 0 Percentage of participants |
Secondary
Percentage of Participants Who Permanently Discontinued Study Treatment Due to AEs - Randomized Phase
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Data for percentage of participants who permanently discontinued study treatment due to any AE over 52 weeks has been summarized.
Time frame: Up to Week 52
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTG 50 mg | Percentage of Participants Who Permanently Discontinued Study Treatment Due to AEs - Randomized Phase | 0 Percentage of participants |
| EFV 600 mg | Percentage of Participants Who Permanently Discontinued Study Treatment Due to AEs - Randomized Phase | 5 Percentage of participants |
Secondary
Percentage of Participants Without Confirmed Virologic Withdrawal and Without Discontinuation Due to Treatment-related Reasons at Week 24 and Week 48
Percentage of participants not meeting confirmed virologic withdrawal criteria nor discontinued due to treatment related reasons at the time of analysis at Week 24 (through Day 210) and Week 48 (through Day 350) has been presented by treatment group. The time to meeting confirmed virologic withdrawal criteria or discontinuation due to treatment related reasons (i.e., discontinuation due to drug-related adverse event \[AE\], or due to protocol defined safety stopping criteria, or due to lack of efficacy) were calculated. Participants who met confirmed virologic withdrawal criteria or discontinuation due to treatment related reasons were considered as Failure. Participants who had not met confirmed virologic withdrawal criteria (per protocol) and were ongoing in the study, or who had discontinued for reasons other than those related to treatment, were censored. This would be the Treatment-Related Discontinuation = Failure (TRDF) data.
Time frame: Week 24 and Week 48
Population: ITT-E Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTG 50 mg | Percentage of Participants Without Confirmed Virologic Withdrawal and Without Discontinuation Due to Treatment-related Reasons at Week 24 and Week 48 | Week 24 | 98.4 Percentage of participants |
| DTG 50 mg | Percentage of Participants Without Confirmed Virologic Withdrawal and Without Discontinuation Due to Treatment-related Reasons at Week 24 and Week 48 | Week 48 | 96.6 Percentage of participants |
| EFV 600 mg | Percentage of Participants Without Confirmed Virologic Withdrawal and Without Discontinuation Due to Treatment-related Reasons at Week 24 and Week 48 | Week 24 | 95.2 Percentage of participants |
| EFV 600 mg | Percentage of Participants Without Confirmed Virologic Withdrawal and Without Discontinuation Due to Treatment-related Reasons at Week 24 and Week 48 | Week 48 | 92.7 Percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/Milliliter at Week 24 in Both EFV and DTG Arms Using the Modified Snapshot Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with plasma HIV-1 RNA \<50 copies/milliliter were assessed at Week 24 using the snapshot algorithm in the DTG and EFV arm. Response was assessed according to the Modified Snapshot algorithm. In this approach participants with HIV-1 RNA \>=50 copies/milliliter were considered non-responders. Participants without HIV-1 RNA data at Week 24 (due to missing data or discontinuation of IP prior to visit window) were also considered as non-responders, as well as participants with ART substitutions were not permitted. Substitution of a background NRTI agent was permissible one time if it was due to reasons of drug toxicity.
Time frame: Week 24
Population: ITT-E Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTG 50 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/Milliliter at Week 24 in Both EFV and DTG Arms Using the Modified Snapshot Algorithm | 81 Percentage of participants |
| EFV 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/Milliliter at Week 24 in Both EFV and DTG Arms Using the Modified Snapshot Algorithm | 89 Percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/Milliliter at Week 48 in EFV Arm Using the Modified Snapshot Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with plasma HIV-1 RNA \<50 copies/milliliter were assessed at Week 48 using the snapshot algorithm in the EFV arm. Response was assessed using a modified FDA Snapshot algorithm in which participants were not penalized for any single protocol allowed background therapy substitution even if occurs after the first trial visit. In this approach participants with HIV-1 RNA \>=50 copies/milliliter are considered as non-responders. Participants without HIV-1 RNA data at Week 48 (due to missing data or discontinuation of IP prior to visit window) are also considered as non-responders, as well as participants with ART substitutions were not permitted. Study drug (i.e. DTG or EFV) was not allowed to be substituted.
Time frame: Week 48
Population: ITT-E Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTG 50 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/Milliliter at Week 48 in EFV Arm Using the Modified Snapshot Algorithm | 82 Percentage of participants |
Secondary
Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48
Samples for lipid measurements were obtained in a fasted state at Baseline, Week 24 and Week 48. The parameters assessed during the lipid profile were total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, triglycerides. Baseline was defined as the last pre-treatment value observed (typically from Day 1 visit). Percent change from Baseline for a parameter was calculated as the observed value minus the Baseline value divided by Baseline value multiplied by 100. Data for fasting lipid parameters has been summarized.
Time frame: Baseline (Day 1), Week 24 and Week 48
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented as n=X in the category titles). Data for this outcome measure has been presented until Week 48 only (Randomized Phase) as per protocol. It was not planned for OLE Phase, hence data was not collected for OLE Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG 50 mg | Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 | Cholesterol, Week 24, n=58, 40 | 6.314 Percent change | Standard Deviation 20.7036 |
| DTG 50 mg | Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 | Cholesterol, Week 48, n=47, 34 | -0.375 Percent change | Standard Deviation 21.489 |
| DTG 50 mg | Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 | HDL Cholesterol, Week 24, n=58, 40 | 39.002 Percent change | Standard Deviation 53.506 |
| DTG 50 mg | Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 | HDL Cholesterol, Week 48, n=47, 34 | 24.987 Percent change | Standard Deviation 48.2471 |
| DTG 50 mg | Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 | LDL Cholesterol, Week 24, n=58, 40 | 4.315 Percent change | Standard Deviation 31.7095 |
| DTG 50 mg | Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 | LDL Cholesterol, Week 48, n=47, 34 | -2.957 Percent change | Standard Deviation 31.991 |
| DTG 50 mg | Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 | Triglycerides, Week 24, n=58, 40 | -22.744 Percent change | Standard Deviation 33.4148 |
| DTG 50 mg | Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 | Triglycerides, Week 48, n=47, 34 | -18.402 Percent change | Standard Deviation 39.0227 |
| EFV 600 mg | Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 | Triglycerides, Week 48, n=47, 34 | 13.175 Percent change | Standard Deviation 57.0389 |
| EFV 600 mg | Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 | Cholesterol, Week 24, n=58, 40 | 16.443 Percent change | Standard Deviation 22.0445 |
| EFV 600 mg | Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 | LDL Cholesterol, Week 24, n=58, 40 | 13.487 Percent change | Standard Deviation 36.2511 |
| EFV 600 mg | Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 | Cholesterol, Week 48, n=47, 34 | 17.371 Percent change | Standard Deviation 20.6312 |
| EFV 600 mg | Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 | Triglycerides, Week 24, n=58, 40 | 16.934 Percent change | Standard Deviation 118.7319 |
| EFV 600 mg | Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 | HDL Cholesterol, Week 24, n=58, 40 | 39.174 Percent change | Standard Deviation 49.1087 |
| EFV 600 mg | Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 | LDL Cholesterol, Week 48, n=47, 34 | 9.132 Percent change | Standard Deviation 41.1942 |
| EFV 600 mg | Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 | HDL Cholesterol, Week 48, n=47, 34 | 45.423 Percent change | Standard Deviation 52.9949 |