Trial Outcomes & Findings for Regimen Switch to Dolutegravir/Lamivudine Fixed Dose Combination From Current Antiretroviral Regimen in HIV-1 Infected and Virologically Suppressed Adults (SALSA) (NCT NCT04021290)

Last Updated: 2023-10-19

Results Overview

Number of participants with plasma HIV 1 RNA \>=50 c/mL were evaluated using FDA snapshot algorithm at Week 48 to demonstrate the non-inferior antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL ), along with study drug discontinuation status. Participants with plasma HIV 1 RNA \>=50 c/mL were termed as subjects with virologic failure. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

493 participants

Primary outcome timeframe

Week 48

Results posted on

2023-10-19

Participant Flow

The study consist of two phases - Randomized phase and Continuation phase.

A total of 493 adult participants were enrolled in this study. Continuation Phase was not applicable for participants in Sweden and Denmark.

Participant milestones

Participant milestones
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.	Continuation Phase-Participants Who Received DTG/3TC FDC Participants who completed 52 weeks of treatment of DTG/3TC FDC had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase up to week 132.
Randomized Phase (Day1 to Week 52) STARTED	246	247	0
Randomized Phase (Day1 to Week 52) COMPLETED	136	229	0
Randomized Phase (Day1 to Week 52) NOT COMPLETED	110	18	0
Continuation Phase (Week 52 to Week 132) STARTED	0	0	96
Continuation Phase (Week 52 to Week 132) COMPLETED	0	0	91
Continuation Phase (Week 52 to Week 132) NOT COMPLETED	0	0	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.	Continuation Phase-Participants Who Received DTG/3TC FDC Participants who completed 52 weeks of treatment of DTG/3TC FDC had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase up to week 132.
Randomized Phase (Day1 to Week 52) Adverse Event	4	3	0
Randomized Phase (Day1 to Week 52) Lack of Efficacy	0	3	0
Randomized Phase (Day1 to Week 52) Lost to Follow-up	2	1	0
Randomized Phase (Day1 to Week 52) Death	1	0	0
Randomized Phase (Day1 to Week 52) Physician Decision	1	2	0
Randomized Phase (Day1 to Week 52) Withdrawal by Subject	1	5	0
Randomized Phase (Day1 to Week 52) Transferred to continuation phase	96	0	0
Randomized Phase (Day1 to Week 52) Protocol Deviation	5	4	0
Continuation Phase (Week 52 to Week 132) Physician Decision	0	0	1
Continuation Phase (Week 52 to Week 132) Lost to Follow-up	0	0	1
Continuation Phase (Week 52 to Week 132) Lack of Efficacy	0	0	1
Continuation Phase (Week 52 to Week 132) Adverse Event	0	0	2

Baseline Characteristics

Regimen Switch to Dolutegravir/Lamivudine Fixed Dose Combination From Current Antiretroviral Regimen in HIV-1 Infected and Virologically Suppressed Adults (SALSA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=246 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=247 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.	Total n=493 Participants Total of all reporting groups
Age, Continuous	45.5 YEARS STANDARD_DEVIATION 11.04 • n=5 Participants	45.8 YEARS STANDARD_DEVIATION 11.99 • n=7 Participants	45.7 YEARS STANDARD_DEVIATION 11.51 • n=5 Participants
Sex: Female, Male Female	108 Participants n=5 Participants	84 Participants n=7 Participants	192 Participants n=5 Participants
Sex: Female, Male Male	138 Participants n=5 Participants	163 Participants n=7 Participants	301 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	45 Participants n=5 Participants	48 Participants n=7 Participants	93 Participants n=5 Participants
Race/Ethnicity, Customized American Indian OR Alaska Native	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	27 Participants n=5 Participants	36 Participants n=7 Participants	63 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	142 Participants n=5 Participants	140 Participants n=7 Participants	282 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 48

Population: Intent To Treat-Exposed (ITT-E) population included all randomized participants who received at least one dose of study medication either DTG/3TC or CAR.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=246 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=247 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) >=50 Copies/Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Category at Week 48	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 48

Population: Intent To Treat-Exposed

Number of participants with plasma HIV 1 RNA \<50 c/mL were evaluated using FDA snapshot algorithm at Week 48 to demonstrate the antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL ), along with study drug discontinuation status. Participants with plasma HIV 1 RNA \<50 c/mL were termed as subjects with virologic success. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=246 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=247 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Number of Participants With Plasma HIV-1 RNA <50 c/mL Using the FDA Snapshot Algorithm at Week 48	232 Participants	229 Participants

SECONDARY outcome

Timeframe: Week 24

Population: Intent To Treat-Exposed

Number of participants with plasma HIV 1 RNA \>=50 c/mL were evaluated using FDA snapshot algorithm at Week 24 to demonstrate the antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 24 weeks. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL ), along with study drug discontinuation status. Participants with plasma HIV 1 RNA \>=50 c/mL were termed as subjects with virologic failure. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=246 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=247 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Number of Participants With Plasma HIV-1 RNA >=50 c/mL as Per FDA Snapshot Category at Week 24	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 24

Population: Intent To Treat-Exposed

Number of participants with plasma HIV 1 RNA \<50 c/mL were evaluated using FDA snapshot algorithm at Week 24 to demonstrate the antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 24 weeks. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL ), along with study drug discontinuation status. Participants with plasma HIV 1 RNA \<50 c/mL were termed as subjects with virologic success. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=246 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=247 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Number of Participants With Plasma HIV-1 RNA <50 c/mL Using the FDA Snapshot Algorithm at Week 24	234 Participants	237 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 24

Population: Intent To Treat-Exposed. Only those participants with data available at specified time points were analyzed.

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry. Change from Baseline in CD4+ lymphocyte count was assessed at Week 24 to evaluate the immune effects of DTG/3TC FDC once daily compared to continuation of CAR. Plasma samples for lymphocyte subsets were collected.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=232 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=235 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Week 24	30.5 cells/cubic millimeter (cells/mm^3) Interval -71.5 to 111.0	10 cells/cubic millimeter (cells/mm^3) Interval -79.0 to 95.0

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

Population: Intent To Treat-Exposed. Only those participants with data available at specified time points were analyzed.

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry. Change from Baseline in CD4+ lymphocyte count was assessed at Week 48 to evaluate the immune effects of DTG/3TC FDC once daily compared to continuation of CAR. Plasma samples for lymphocyte subsets were collected.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=232 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=227 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Change From Baseline in CD4+ Cell Count for Week 48	30 cells/mm^3 Interval -83.0 to 115.5	2 cells/mm^3 Interval -105.0 to 94.0

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 24

Population: Intent To Treat-Exposed. Only those participants with data available at specified time points were analyzed.

CD4+/CD8+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry. Change from Baseline in CD4+/CD8+ lymphocyte cell count ratio was assessed at Week 24 to evaluate the immune effects of DTG/3TC FDC once daily compared to continuation of CAR. Plasma samples for lymphocyte subsets were collected.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=232 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=235 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Change From Baseline in CD4+/ Cluster of Differentiation 8 (CD8+) Cell Counts Ratio for Week 24	-0.02 Ratio Interval -0.105 to 0.07	0.01 Ratio Interval -0.06 to 0.09

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

Population: Intent To Treat-Exposed. Only those participants with data available at specified time points were analyzed.

CD4+/CD8+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry. Change from Baseline in CD4+/CD8+ lymphocyte cell count ratio was assessed at Week 48 to evaluate the immune effects of DTG/3TC FDC once daily compared to continuation of CAR. Plasma samples for lymphocyte subsets were collected.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=232 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=227 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Change From Baseline in CD4+/CD8+ Cell Counts Ratio for Week 48	0.04 Ratio Interval -0.06 to 0.13	0.05 Ratio Interval -0.06 to 0.13

SECONDARY outcome

Timeframe: Up to Week 24

Population: Intent To Treat-Exposed

Participants with disease progression included incidences of HIV-associated conditions, Acquired Immuno Deficiency Syndrome (AIDS) and death. HIV-associated conditions were assessed according to the 2014 HIV infection by Centers for Disease Control and Prevention (CDC) classification system for HIV Infection in adults to evaluate the immune effects of DTG /3TC FDC once daily compared to continuation of CAR.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=246 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=247 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Number of Participants With Disease Progression Through Week 24	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: Intent To Treat-Exposed

Participants with disease progression included incidences of HIV-associated conditions, AIDS and death. HIV-associated conditions were assessed according to the 2014 HIV infection by CDC classification system for HIV Infection in adults to evaluate the immune effects of DTG /3TC FDC once daily compared to continuation of CAR.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=246 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=247 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Number of Participants With Disease Progression Through Week 48	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: Safety population included all randomized participants who received at least 1 dose of study intervention either DTG/3TC or CAR.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=246 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=247 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Number of Participants With Adverse Events (AEs) and AEs Leading to Discontinuation AEs	180 Participants	172 Participants
Number of Participants With Adverse Events (AEs) and AEs Leading to Discontinuation AEs leading to discontinuation	5 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: Safety population

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=246 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=247 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Number of Participants With AEs by Severity Grades Grade 1	92 Participants	67 Participants
Number of Participants With AEs by Severity Grades Grade 2	77 Participants	86 Participants
Number of Participants With AEs by Severity Grades Grade 3	10 Participants	17 Participants
Number of Participants With AEs by Severity Grades Grade 4	0 Participants	2 Participants
Number of Participants With AEs by Severity Grades Grade 5	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: Safety population

Blood samples were collected to evaluate hepatobiliary abnormalities. Number of participants with Bilirubin (BIL), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT)/combination of these with levels more than the defined hepatobiliary abnormality criteria were presented. Hepatocellular injury is defined as (\[ALT/ALT ULN\]/\[ALP/ALP ULN\]) \>= 5 and ALT \>=3xULN.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=246 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=247 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks ALT >=3xUpper Limit of Normal (ULN) & BIL >=2xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks ALT >=3xULN & ALP <2xULN & BIL >=2xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks ALT >=3xULN & BIL >=1.5xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks AST >=3xULN & BIL >=2xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks AST >=3xULN & ALP <2xULN & BIL >=2xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks AST >=3xULN & BIL >=1.5xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks ALT+AST >=20xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks ALT+AST >=10xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks ALT+AST >=5xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks ALT >=5xULN	1 Participants	1 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks AST >=10xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks AST >=5xULN	1 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks BIL >=2xULN	0 Participants	5 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks ALP >=1.5xULN	4 Participants	8 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks ALT >=3xULN - <5xULN	5 Participants	4 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks ALT >=5xULN - <10xULN	1 Participants	1 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks ALT >=10xULN - <20xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks ALT+AST >=3xULN	3 Participants	2 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks ALT >=20xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks ALT >=10xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks ALT >=3xULN	6 Participants	5 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks AST >=20xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks AST >=3xULN	5 Participants	2 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks BIL >=1.5xULN	0 Participants	7 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Hepatocellular injury	5 Participants	1 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Hepatocellular injury and BIL >=2xULN	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: Safety population. Only those participants with data available at specified time points were analyzed.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with any AE were presented and AEs were graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=1 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=4 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Number of Participants With Any AEs and AEs by Severity Grades for Those Participants With Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 Grade 1	1 Participants	1 Participants
Number of Participants With Any AEs and AEs by Severity Grades for Those Participants With Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 Grade 2	0 Participants	2 Participants
Number of Participants With Any AEs and AEs by Severity Grades for Those Participants With Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 Grade 3	0 Participants	0 Participants
Number of Participants With Any AEs and AEs by Severity Grades for Those Participants With Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 Grade 4	0 Participants	0 Participants
Number of Participants With Any AEs and AEs by Severity Grades for Those Participants With Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 Any Event	1 Participants	3 Participants
Number of Participants With Any AEs and AEs by Severity Grades for Those Participants With Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 Grade 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: Safety Population. Only those participants with data available at specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=245 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=243 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Number of Participants With Any AEs and AEs by Severity Grades for Those Participants With Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 Any Event	179 Participants	169 Participants
Number of Participants With Any AEs and AEs by Severity Grades for Those Participants With Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 Grade 1	91 Participants	66 Participants
Number of Participants With Any AEs and AEs by Severity Grades for Those Participants With Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 Grade 2	77 Participants	84 Participants
Number of Participants With Any AEs and AEs by Severity Grades for Those Participants With Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 Grade 3	10 Participants	17 Participants
Number of Participants With Any AEs and AEs by Severity Grades for Those Participants With Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 Grade 4	0 Participants	2 Participants
Number of Participants With Any AEs and AEs by Severity Grades for Those Participants With Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 Grade 5	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: Safety population. Only those participants with data available at specified time points were analyzed.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=1 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=4 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Number of Participants With Any AEs Leading to Discontinuation Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: Safety population. Only those participants with data available at specified time points were analyzed.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=245 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=243 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Number of Participants With Any AEs Leading to Discontinuation Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: Safety population. Only those participants with data available at specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=1 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=4 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 ALT >=3xULN & BIL >=1.5xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 ALT >=3xULN & ALP <2xULN & BIL >=2xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 AST >=3xULN & ALP <2xULN & BIL >=2xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 AST >=3xULN & BIL >=1.5xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 ALT+AST >=20xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 ALT+AST >=10xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 ALT >=10xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 ALT >=5xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 ALT >=3xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 AST >=20xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 AST >=5xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 AST >=3xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 BIL >=2xULN	0 Participants	1 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 ALT >=3xULN - <5xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 ALT >=5xULN - <10xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 ALT >=10xULN - <20xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 Hepatocellular injury	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 ALT >=3xUpper Limit of Normal (ULN) & BIL >=2xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 AST >=3xULN & BIL >=2xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 ALT+AST >=5xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 ALT+AST >=3xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 ALT >=20xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 AST >=10xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 BIL >=1.5xULN	0 Participants	1 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 ALP >=1.5xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2 Hepatocellular injury and BIL >=2xULN	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: Safety population. Only those participants with data available at specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=245 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=243 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 Hepatocellular injury and BIL >=2xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 AST >=3xULN & ALP <2xULN & BIL >=2xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 AST >=3xULN & BIL >=1.5xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 ALT+AST >=20xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 ALT+AST >=10xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 ALT+AST >=5xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 ALT >=10xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 ALT >=5xULN	1 Participants	1 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 AST >=5xULN	1 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 AST >=3xULN	5 Participants	2 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 BIL >=2xULN	0 Participants	4 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 BIL >=1.5xULN	0 Participants	6 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 ALT >=3xULN - <5xULN	5 Participants	4 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 Hepatocellular injury	5 Participants	1 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 ALT >=3xUpper Limit of Normal (ULN) & BIL >=2xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 ALT >=3xULN & ALP <2xULN & BIL >=2xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 ALT >=3xULN & BIL >=1.5xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 AST >=3xULN & BIL >=2xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 ALT+AST >=3xULN	3 Participants	2 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 ALT >=20xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 ALT >=3xULN	6 Participants	5 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 AST >=20xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 AST >=10xULN	0 Participants	0 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 ALP >=1.5xULN	4 Participants	8 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 ALT >=5xULN - <10xULN	1 Participants	1 Participants
Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2 ALT >=10xULN - <20xULN	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 24

Population: Safety Population. Only those participants with data available at specified time points has been analyzed.

Lipid parameters included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=191 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=168 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Change From Baseline in Fasting Lipids at Week 24 Serum or Plasma Triglycerides (mg/dL)	-4.944 milligram/deciliter (mg/dL) Standard Deviation 56.4947	-3.571 milligram/deciliter (mg/dL) Standard Deviation 61.9494
Change From Baseline in Fasting Lipids at Week 24 Serum or Plasma HDL Cholesterol, Direct (mg/dL)	-0.326 milligram/deciliter (mg/dL) Standard Deviation 9.1737	0.585 milligram/deciliter (mg/dL) Standard Deviation 8.3277
Change From Baseline in Fasting Lipids at Week 24 Serum or Plasma LDL Cholesterol (Calculated or Direct), (mg/dL)	-1.64 milligram/deciliter (mg/dL) Standard Deviation 25.5153	-0.06 milligram/deciliter (mg/dL) Standard Deviation 19.802
Change From Baseline in Fasting Lipids at Week 24 Serum or Plasma Cholesterol (mg/dL)	-3.096 milligram/deciliter (mg/dL) Standard Deviation 31.6634	0.058 milligram/deciliter (mg/dL) Standard Deviation 25.8019

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

Population: Safety Population. Only those participants with data available at specified time points has been analyzed.

Lipid parameters included total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=186 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=159 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Change From Baseline in Fasting Lipids at Week 48 Serum or Plasma Triglycerides (mg/dL)	-3.112 mg/dL Standard Deviation 66.9065	-4.002 mg/dL Standard Deviation 71.0132
Change From Baseline in Fasting Lipids at Week 48 Serum or Plasma HDL Cholesterol, Direct (mg/dL)	-0.809 mg/dL Standard Deviation 10.5651	0.688 mg/dL Standard Deviation 8.5584
Change From Baseline in Fasting Lipids at Week 48 Serum or Plasma Cholesterol (mg/dL)	0.131 mg/dL Standard Deviation 30.271	2.668 mg/dL Standard Deviation 27.0351
Change From Baseline in Fasting Lipids at Week 48 Serum or Plasma LDL Cholesterol (Calculated or Direct), (mg/dL)	1.753 mg/dL Standard Deviation 22.8585	2.734 mg/dL Standard Deviation 20.0256

SECONDARY outcome

Timeframe: Up to week 48

Population: Confirmed Virologic Withdrawal (CVW) population. No participants met the CVW criteria over 48 weeks; therefore, the genotypic and phenotypic resistance virologic analyses were not assessed.

Genotypic and phenotypic testing was conducted for participants who met the CVW criteria, i.e., one assessment with HIV-1 RNA ≥200 c/mL after Day 1 with an immediately prior HIV-1 RNA ≥50 c/mL at any point in the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 24

Population: ITT-E. Only those participants with data available at specified time points has been analyzed.

The HIV Treatment Satisfaction Questionnaire (HIVTSQ) is a 10-item self-reported scale that consists of a total score ranging from 0 to 60. Higher scores indicate a greater level of patient-reported satisfaction with their current therapy.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=236 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=240 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Change From Baseline in Health Status by HIV Treatment Satisfaction Questionnaire (TSQ) at Week 24	2.9 Scores on a scale Standard Deviation 5.85	1 Scores on a scale Standard Deviation 5.16

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

Population: ITT-E. Only those participants with data available at specified time points has been analyzed.

The HIVTSQ is a 10-item self-reported scale that consists of a total score ranging from 0 to 60. Higher scores indicate a greater level of patient-reported satisfaction with their current therapy.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=229 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=229 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Change From Baseline in Health Status by HIV TSQ at Week 48	2.9 Scores on a scale Standard Deviation 6	1 Scores on a scale Standard Deviation 5.14

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 24

Population: ITT-E. Only those participants with data available at specified time points has been analyzed.

SDM is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Each item is rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health).

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=235 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=239 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Change From Baseline in Health Status by Symptom Distress Module (SDM) at Week 24	-2.6 Scores on a scale Standard Deviation 8.69	-0.7 Scores on a scale Standard Deviation 8.01

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

Population: ITT-E. Only those participants with data available at specified time points has been analyzed.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=228 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR n=226 Participants Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Change From Baseline in Health Status by SDM at Week 48	-2.4 Scores on a scale Standard Deviation 7.64	-1.5 Scores on a scale Standard Deviation 7.92

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 76, Week 100, and Week 132

Population: Intent To Treat-Exposed (ITT-E) Continuation Phase population included participants who received at least one dose of DTG/3TC during continuation phase. Only those participants with data available at specified time points has been analyzed.

Outcome measures

Outcome measures
Measure	Randomized Phase-Participants Who Received DTG/3TC FDC n=96 Participants Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Randomized Phase-Participants Who Received CAR Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
Change From Baseline in Health Status by SDM in Continuation Phase Week 76	-4.1 Scores on a scale Standard Deviation 8.69	—
Change From Baseline in Health Status by SDM in Continuation Phase Week 100	-3.4 Scores on a scale Standard Deviation 11.33	—
Change From Baseline in Health Status by SDM in Continuation Phase Week 132	-6.1 Scores on a scale Standard Deviation 9.94	—

Adverse Events

Randomized Phase-Participants Who Received DTG/3TC FDC

Serious events: 7 serious events

Other events: 179 other events

Deaths: 1 deaths

Randomized Phase-Participants Who Received CAR

Serious events: 16 serious events

Other events: 169 other events

Deaths: 0 deaths

Continuation Phase-Participants Who Received DTG/3TC FDC

Serious events: 1 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER