Trial Outcomes & Findings for Rapid Test and Treat Dolutegravir Plus Lamivudine Study in Newly Diagnosed Human Immunodeficiency Virus (HIV)-1 Infected Adults (NCT NCT03945981)

Last Updated: 2021-10-21

Results Overview

Participants were classified as "HIV-1 RNA \<50 c/mL" using an ITT-E missing = Failure analysis. Participants were classified as 'HIV-1 RNA \< 50 c/mL' if the last viral load within the Week 24 visit window was \<50/c/mL, regardless of the ART regimen they were on at the time of viral load assessment (in other words switch from DTG plus 3TC fixed-dose combination \[FDC\] to another ART was not penalized) and as HIV-1 RNA \>= 50 c/mL in all other cases (i.e. last viral load within Week 24 visit window \>= 50 c/mL, on study but having missing viral load data at Week 24, discontinued early from study due to lost to follow-up (LFU), withdrew consent or any other reason). Confidence intervals (CI) were calculated based on the Exact Clopper-Pearson method. Percentage of participants with plasma HIV-1 RNA \< 50 c/mL based on ITT-E missing = Failure analysis at Week 24 are presented.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

131 participants

Primary outcome timeframe

At Week 24

Results posted on

2021-10-21

Participant Flow

This was an open-label single arm study to evaluate the feasibility, efficacy and safety of a rapid Test and Treat intervention in newly diagnosed human immunodeficiency viruses (HIV)-1 infected adults using a fixed dose combination of dolutegravir (DTG) plus lamivudine (3TC) as a first line regimen.

A total of 133 participants were screened and 131 participants were enrolled in the study.

Participant milestones

Participant milestones
Measure	DTG Plus 3TC Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Overall Study STARTED	131
Overall Study COMPLETED	108
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	DTG Plus 3TC Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Overall Study Lost to Follow-up	12
Overall Study Physician Decision	4
Overall Study Withdrawal by Subject	6
Overall Study Protocol Violation	1

Baseline Characteristics

Rapid Test and Treat Dolutegravir Plus Lamivudine Study in Newly Diagnosed Human Immunodeficiency Virus (HIV)-1 Infected Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DTG Plus 3TC n=131 Participants Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Age, Continuous	34.6 Years STANDARD_DEVIATION 11.46 • n=5 Participants
Sex/Gender, Customized Male	120 Participants n=5 Participants
Sex/Gender, Customized Female	10 Participants n=5 Participants
Sex/Gender, Customized Transgender Female	1 Participants n=5 Participants
Race/Ethnicity, Customized American (Amer.) Indian(Ind.)orAlaska(Ala.)Native	1 Participants n=5 Participants
Race/Ethnicity, Customized Central/South Asian Heritage	2 Participants n=5 Participants
Race/Ethnicity, Customized African American/African (Afr.) Heritage (Her.)	61 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian/European Heritage	65 Participants n=5 Participants
Race/Ethnicity, Customized Afr.Amer./Afr. Her. and Amer. Ind. or Ala. Native	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 24

Population: Intent-To-Treat Exposed (ITT-E) Population was used which comprised of all enrolled participants who received at least one dose of study treatment. ITT-E missing = Failure analysis is mentioned as 'Observed analysis' in the protocol.

Outcome measures

Outcome measures
Measure	DTG Plus 3TC n=131 Participants Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) Regardless of Antiretroviral Therapy (ART) Regimen at Week 24 by ITT-E Missing = Failure Analysis	78 Percentage of Participants Interval 69.8 to 84.6

SECONDARY outcome

Timeframe: At Week 48

Population: Intent-to-Treat Exposed Population

Participants were classified as "HIV-1 RNA \<50 c/mL" using an ITT-E Missing = Failure analysis. Participants were classified as 'HIV-1 RNA \< 50 c/mL' if the last viral load within the Week 48 visit window was \<50/c/mL, regardless of the ART regimen they were on at the time of viral load assessment (in other words switch from DTG plus 3TC FDC to another ART was not penalized) and as HIV-1 RNA \>= 50 c/mL in all other cases (i.e. last viral load within Week 48 visit window \>= 50 c/mL, on study but having missing viral load data at Week 48, discontinued early from study due to LFU, withdrew consent or any other reason). CI were calculated based on the Exact Clopper-Pearson method. Percentage of participants with plasma HIV-1 RNA \< 50 c/mL based on ITT-E missing = Failure analysis at Week 48 are presented.

Outcome measures

Outcome measures
Measure	DTG Plus 3TC n=131 Participants Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Regardless of ART Regimen at Week 48 by ITT-E Missing = Failure Analysis	82 Percentage of Participants Interval 74.0 to 87.9

SECONDARY outcome

Timeframe: At Week 24 and Week 48

Population: Intent-to-Treat Exposed Population

Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (either due to missing plasma HIV-1 RNA assessment but on study, or due to permanent discontinuation of study treatment prior to visit window) as virologic non-success, as well as participants who switched from first line regimen of DTG + 3TC FDC for any reason prior to the visit of interest. Confidence intervals were calculated based on the Exact Clopper-Pearson method. Percentage of participants with plasma HIV-1 RNA \<50 c/mL obtained using FDA Snapshot algorithm are presented.

Outcome measures

Outcome measures
Measure	DTG Plus 3TC n=131 Participants Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Using Food and Drug Administration (FDA) Snapshot Algorithm Week 24	74 Percentage of Participants Interval 65.7 to 81.3
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL Using Food and Drug Administration (FDA) Snapshot Algorithm Week 48	76 Percentage of Participants Interval 68.1 to 83.3

SECONDARY outcome

Timeframe: Up to Week 48

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

Time of viral suppression for participants who had HIV-1 RNA \>= 50 c/mL at Baseline is defined as the time to first viral load value \< 50 c/mL, irrespective of the ART regimen a participant was on when that occurred. Non parametric Kaplan-Meier method was used. Participants who withdrew for any reason without being suppressed were censored at date of withdrawal. Participants who have not been withdrawn and have not had viral suppression at time of the analysis were censored at last viral load date. Median time (i.e. time when 50% of participants have reached HIV-1 RNA \< 50 c/mL) along with 95% CI is presented.

Outcome measures

Outcome measures
Measure	DTG Plus 3TC n=126 Participants Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Time to Viral Suppression (HIV-1 RNA<50 c/mL) for Participants Who Had HIV-1 RNA >= 50 c/mL at Baseline	35 Days Interval 30.0 to 55.0

SECONDARY outcome

Timeframe: Up to Week 48

Population: Intent-to-Treat Exposed Population

Number of participants who switched from first line regimen of DTG + 3TC FDC due to abnormal Baseline laboratory values or Baseline HIV-1 resistance mutation results are presented.

Outcome measures

Outcome measures
Measure	DTG Plus 3TC n=131 Participants Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Number of Participants Who Changed First Line Regimen of DTG + 3TC FDC Due to Baseline Laboratory Results or HIV-1 Resistance Mutation Results Switched due to abnormal Baseline laboratory results (HBV Infection)	5 Participants
Number of Participants Who Changed First Line Regimen of DTG + 3TC FDC Due to Baseline Laboratory Results or HIV-1 Resistance Mutation Results Switched due to HIV-1 resistance mutation results	1 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: HIV-1 Viral Genotypic Population comprised of all participants in the ITT-E Population who had available post-Baseline HIV-1 genotypic resistance data either for DTG + 3TC FDC or any other ART. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected for genotypic resistance testing post-Baseline when Confirmed Virologic Failure criteria were met or in other occasion as needed (e.g. at time of study withdrawal when HIV-1 RNA \>= 400 c/mL). New mutations were tabulated by drug class: integrase strand transfer inhibitor (INSTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI) and protease inhibitor (PI). Number of participants with treatment-emergent resistance associated mutations to any class (INSTI, NNRTI, NRTI, PI) from post-Baseline genotypic resistance data up to Week 48 have been presented.

Outcome measures

Outcome measures
Measure	DTG Plus 3TC n=4 Participants Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Number of Participants With Treatment-emergent Genotypic Resistance NNRTI	0 Participants
Number of Participants With Treatment-emergent Genotypic Resistance INSTI	0 Participants
Number of Participants With Treatment-emergent Genotypic Resistance NRTI	0 Participants
Number of Participants With Treatment-emergent Genotypic Resistance PI	0 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: HIV-1 Viral Phenotypic Population comprised of all participants in the ITT-E Population who had available post-Baseline HIV-1 phenotypic resistance data either under treatment with DTG + 3TC FDC or any other ART. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected for drug resistance testing post-Baseline when Confirmed Virologic Failure criteria were met or in other occasion as needed (e.g. at time of study withdrawal when HIV-1 RNA \>= 400 c/mL). Assessment of antiviral activity of ART using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drug. Number of participants with phenotypic resistance to DTG and/or 3TC or any other ART (if treatment is modified) taken during the study in participants with post-Baseline phenotypic resistance data up to Week 48 have been presented.

Outcome measures

Outcome measures
Measure	DTG Plus 3TC n=3 Participants Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Number of Participants With Treatment-emergent Phenotypic Resistance	0 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety Population comprised of all enrolled participants who received at least one dose of study treatment.

An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as judged by physician. Number of participants with any SAE and common (\>=2%) non-SAEs are presented.

Outcome measures

Outcome measures
Measure	DTG Plus 3TC n=131 Participants Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Number of Participants With Any Serious Adverse Events (SAEs) and Any Common (>=2%) Non-serious Adverse Events (Non-SAEs) Under Treatment With DTG + 3TC FDC Any non-SAE	85 Participants
Number of Participants With Any Serious Adverse Events (SAEs) and Any Common (>=2%) Non-serious Adverse Events (Non-SAEs) Under Treatment With DTG + 3TC FDC Any SAE	2 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety Population

Blood samples were collected up to Week 48 visit for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Higher grade indicates more severity. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented.

Outcome measures

Outcome measures
Measure	DTG Plus 3TC n=131 Participants Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Under Treatment With DTG + 3TC FDC Platelets, Grade 3	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Under Treatment With DTG + 3TC FDC Hemoglobin, Grade 1	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Under Treatment With DTG + 3TC FDC Hemoglobin, Grade 2	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Under Treatment With DTG + 3TC FDC Hemoglobin, Grade 3	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Under Treatment With DTG + 3TC FDC Hemoglobin, Grade 4	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Under Treatment With DTG + 3TC FDC Leukocytes, Grade 1	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Under Treatment With DTG + 3TC FDC Leukocytes, Grade 2	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Under Treatment With DTG + 3TC FDC Leukocytes, Grade 3	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Under Treatment With DTG + 3TC FDC Leukocytes, Grade 4	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Under Treatment With DTG + 3TC FDC Neutrophils, Grade 1	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Under Treatment With DTG + 3TC FDC Neutrophils, Grade 2	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Under Treatment With DTG + 3TC FDC Neutrophils, Grade 3	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Under Treatment With DTG + 3TC FDC Neutrophils, Grade 4	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Under Treatment With DTG + 3TC FDC Platelets, Grade 1	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Under Treatment With DTG + 3TC FDC Platelets, Grade 2	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Under Treatment With DTG + 3TC FDC Platelets, Grade 4	0 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety Population

Blood samples were collected up to Week 48 for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, aspartate aminotransferase (AST), Alkaline Phosphatase (ALP), bilirubin, carbon dioxide (CO2), creatinine kinase (CK), creatinine, glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), glucose, hypercalcemia, hyperkalemia, hypernatremia, hypocalcemia, hypokalemia, hyponatremia and phosphate. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Higher grade indicates more severity. Only those participants with maximum post-Baseline emergent chemistry toxicities in any of the chemistry parameters have been presented.

Outcome measures

Outcome measures
Measure	DTG Plus 3TC n=131 Participants Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC GFR from creatinine adjusted for BSA,Grade 2	38 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hyponatremia, Grade 2	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC ALT, Grade 1	7 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC ALT, Grade 2	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC ALT, Grade 3	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC ALT, Grade 4	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Albumin, Grade 1	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Albumin, Grade 2	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Albumin, Grade 3	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Albumin, Grade 4	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC AST, Grade 1	6 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC AST, Grade 2	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC AST, Grade 3	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC AST, Grade 4	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Bilirubin, Grade 1	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Bilirubin, Grade 2	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Bilirubin, Grade 3	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Bilirubin, Grade 4	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC CO2, Grade 1	20 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC CO2, Grade 2	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC CO2, Grade 3	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC CO2, Grade 4	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC CK, Grade 1	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC CK, Grade 2	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC CK, Grade 3	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC CK, Grade 4	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Creatinine, Grade 1	9 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Creatinine, Grade 2	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Creatinine, Grade 3	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Creatinine, Grade 4	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC GFR from creatinine adjusted for BSA,Grade 1	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC GFR from creatinine adjusted for BSA,Grade 3	8 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC GFR from creatinine adjusted for BSA,Grade 4	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Glucose, Grade 1	27 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Glucose, Grade 2	14 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Glucose, Grade 3	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Glucose, Grade 4	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hypercalcaemia, Grade 1	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hypercalcaemia, Grade 2	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hypercalcaemia, Grade 3	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hypercalcaemia, Grade 4	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hyperkalemia, Grade 1	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hyperkalemia, Grade 2	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hyperkalemia, Grade 3	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hyperkalemia, Grade 4	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hypernatremia, Grade 1	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hypernatremia, Grade 2	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hypernatremia, Grade 3	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hypernatremia, Grade 4	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hypokalemia, Grade 1	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hypokalemia, Grade 2	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hypokalemia, Grade 3	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hypokalemia, Grade 4	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hyponatremia, Grade 1	9 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hyponatremia, Grade 3	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hyponatremia, Grade 4	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Phosphate, Grade 1	8 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Phosphate, Grade 2	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Phosphate, Grade 3	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Phosphate, Grade 4	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hypocalcaemia, Grade 1	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hypocalcaemia, Grade 2	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hypocalcaemia, Grade 3	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC Hypocalcaemia, Grade 4	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC ALP, Grade 1	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC ALP, Grade 2	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC ALP, Grade 3	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Under Treatment With DTG + 3TC FDC ALP, Grade 4	0 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety Population

Outcome measures

Outcome measures
Measure	DTG Plus 3TC n=131 Participants Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Number of Participants Who Discontinued the Study Treatment (DTG+3TC FDC) Due to AEs	1 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety Population

An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued the study treatment (DTG+3TC FDC) due to drug-related AEs are presented.

Outcome measures

Outcome measures
Measure	DTG Plus 3TC n=131 Participants Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Number of Participants Who Discontinued the Study Treatment (DTG+3TC FDC) Due to Drug-related AEs	1 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 24 and Week 48

Population: Intent-to-Treat Exposed Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells decline. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG Plus 3TC n=106 Participants Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Change From Baseline in Cluster of Differentiation (CD4+) Cell Counts for Participants Under Treatment With DTG + 3TC FDC Week 24, n=106	185.9 Cells per cubic millimeter Standard Deviation 163.70
Change From Baseline in Cluster of Differentiation (CD4+) Cell Counts for Participants Under Treatment With DTG + 3TC FDC Week 48, n=103	273.4 Cells per cubic millimeter Standard Deviation 223.93

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 24 and Week 48

Population: Intent-to-Treat Exposed Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio. It was assessed by flow cyclometry to evaluate the immunologic activity of DTG plus 3TC. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG Plus 3TC n=106 Participants Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Change From Baseline in CD4+/CD8+ Cell Count Ratio for Participants Under Treatment With DTG + 3TC FDC Week 24, n= 106	0.30 Ratio Standard Deviation 0.238
Change From Baseline in CD4+/CD8+ Cell Count Ratio for Participants Under Treatment With DTG + 3TC FDC Week 48, n=102	0.39 Ratio Standard Deviation 0.260

SECONDARY outcome

Timeframe: Up to Week 48

Population: Intent-to-Treat Exposed Population

HIV-associated conditions were recorded during the study and was assessed according to the 2014 Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. CDC classification for HIV were stage 1, 2 and 3. Higher stage indicates more severity. Disease progression summarize participants who had HIV infection stage 3 associated conditions, AIDS and/or death. Number of participants with HIV-1 disease progression to stage 3 HIV-associated conditions, AIDS or death are presented.

Outcome measures

Outcome measures
Measure	DTG Plus 3TC n=131 Participants Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Number of Participants With HIV-1 Disease Progression to Stage 3 HIV-associated Conditions, Acquired Immunodeficiency Syndrome (AIDS) or Death (for Participants Under Treatment With DTG + 3TC FDC)	1 Participants

SECONDARY outcome

Timeframe: Week 24 and Week 48

Population: Intent-to-Treat Exposed Population

Number of participants who completed 24 and 48 weeks on study are presented.

Outcome measures

Outcome measures
Measure	DTG Plus 3TC n=131 Participants Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Number of Participants Who Completed 24 and 48 Weeks on Study Week 24	115 Participants
Number of Participants Who Completed 24 and 48 Weeks on Study Week 48	112 Participants

SECONDARY outcome

Timeframe: Week 24 and Week 48

Population: Intent-to-Treat Exposed Population

Number of participants retained in care for 24 and 48 weeks on study and have HIV-1 RNA \<200 c/mL have been presented.

Outcome measures

Outcome measures
Measure	DTG Plus 3TC n=131 Participants Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Number of Participants Retained in Care for 24 and 48 Weeks on Study and Have HIV-1 RNA <200 c/mL Week 24	110 Participants
Number of Participants Retained in Care for 24 and 48 Weeks on Study and Have HIV-1 RNA <200 c/mL Week 48	109 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At Week 24 and Week 48

Population: Intent-to-Treat Exposed Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Participants with at least one viral load assessment within Week 24 and 48 visit window have been considered. Participants who discontinued from study prior to Week 24 and Week 48 or who were still on study at Week 24 and Week 48 but with missing viral load assessment have been excluded. Viral load assessments performed under DTG + 3TC FDC treatment or under any Modified ART treatment at Week 24 and Week 48 have been considered. Percentage of participants with HIV-1 RNA \< 50 c/mL at Weeks 24 and 48 among participants with available HIV-1 RNA assessment regardless of ART have been presented.

Outcome measures

Outcome measures
Measure	DTG Plus 3TC n=111 Participants Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Percentage of Participants With HIV-1 RNA < 50 c/mL at Weeks 24 and 48 Among Participants With Available HIV-1 RNA Assessment Regardless of ART Week 24, n=111	92 Percentage of Participants
Percentage of Participants With HIV-1 RNA < 50 c/mL at Weeks 24 and 48 Among Participants With Available HIV-1 RNA Assessment Regardless of ART Week 48, n=110	97 Percentage of Participants

Adverse Events

DTG Plus 3TC

Serious events: 2 serious events

Other events: 85 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DTG Plus 3TC n=131 participants at risk Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Infections and infestations Cellulitis	0.76% 1/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Streptococcal bacteraemia	0.76% 1/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.

Other adverse events

Other adverse events
Measure	DTG Plus 3TC n=131 participants at risk Participants received DTG 50 milligram (mg) and 3TC 300 mg fixed dose combination tablet orally once daily with or without food.
Gastrointestinal disorders Diarrhoea	8.4% 11/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	6.9% 9/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal discomfort	2.3% 3/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Constipation	3.8% 5/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Nervous system disorders Headache	9.2% 12/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Nervous system disorders Dizziness	3.8% 5/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Nervous system disorders Paraesthesia	2.3% 3/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Nasopharyngitis	6.1% 8/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Chlamydial infection	3.1% 4/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Gonorrhoea	3.8% 5/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Upper respiratory tract infection	2.3% 3/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	5.3% 7/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash	6.1% 8/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Acne	2.3% 3/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Psychiatric disorders Insomnia	6.1% 8/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Psychiatric disorders Depression	6.9% 9/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Fatigue	6.1% 8/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Pyrexia	3.1% 4/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Investigations Weight increased	6.1% 8/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Exposure to communicable disease	4.6% 6/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Neck pain	2.3% 3/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	3.1% 4/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Vascular disorders Hypertension	3.8% 5/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Anogenital dysplasia	3.1% 4/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Psychiatric disorders Anxiety	5.3% 7/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations COVID-19	3.8% 5/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Proctitis gonococcal	3.1% 4/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Anal chlamydia infection	2.3% 3/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Herpes simplex	2.3% 3/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Herpes zoster	2.3% 3/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Oropharyngeal gonococcal infection	2.3% 3/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Pharyngitis	2.3% 3/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Tonsillitis	2.3% 3/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	4.6% 6/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	2.3% 3/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	3.1% 4/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Vitamin D deficiency	2.3% 3/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Haemorrhoids	3.1% 4/131 • Serious adverse events (SAEs) and non-serious adverse events were collected from start of study treatment (Week 1) up to end of the study (Week 48). SAEs and non-serious adverse events were reported for the Safety Population which comprised of all enrolled participants who received at least one dose of study treatment.

Additional Information

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GlaxoSmithKline

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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