Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO)

Exclusion Criteria

• •Women who are breastfeeding or plan to become pregnant or breastfeed during the study.
• •Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease, EXCEPT cutaneous Kaposi's sarcoma not requiring systemic therapy. Historical or current CD4 cell counts less than 200 cells/millimeter (mm)\^3 are NOT exclusionary.
• •Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
• •Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• •Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antigen antibody (anti-HBs) and HBV deoxyribonucleic acid (DNA) as follows: participants positive for HBsAg are excluded; participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
• •Anticipated need for any hepatitis C virus (HCV) therapy during the first 48 weeks of the study, or anticipated need for HCV therapy based on interferon or for any drugs that have a potential for adverse drug-drug interactions with study treatment throughout the entire study period.
• •Untreated syphilis infection (positive rapid plasma reagin \[RPR\] at Screening without clear documentation of treatment). Participants who are at least 7 days post completed treatment are eligible.
• •History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.
• •Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia.
• •Participants who in the investigator's judgment, poses a significant suicidality risk.
• •Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
• •Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any systemic immune suppressant.
• •Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of investigational product (IP).
• •Use of any regimen consisting of single or dual ART.
• •Any evidence of major nucleoside reverse transcriptase inhibitor (NRTI) mutation or presence of any major INSTI resistance-associated mutation in any available prior resistance genotype assay test result, if known, must be provided to ViiV after screening and before randomization for review by ViiV Virology.
• •Any verified Grade 4 laboratory abnormality.
• •Alanine aminotransferase (ALT) \>=5 times (\*) the upper limit of normal (ULN) or ALT \>=3 \* ULN and bilirubin \>=1.5 \* ULN (with \>35 percent \[%\] direct bilirubin).
• •Creatinine clearance of \<50 milliliter (mL)/minute/1.73 meter\^2 via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method.
• •Within the 6 to 12 month window prior to Screening and after confirmed suppression to \<50 c/mL, any plasma HIV-1 RNA measurement \>200 c/mL.
• •Within the 6 to 12 month window prior to Screening and after confirmed suppression to \<50 c/mL, 2 or more plasma HIV-1 RNA measurements \>=50 c/mL.
• •Within 6 months prior to Screening and after confirmed suppression to \<50 c/mL on current ART regimen, any plasma HIV-1 RNA measurement \>=50 c/mL.
• •Any drug holiday during the 6 months prior to Screening, except for brief periods (less than 1 month) where all ART was stopped due to tolerability and/or safety concerns.
• •Any history of switch to another regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy (defined as a confirmed plasma HIV-1 RNA ≥400 c/mL.
• •Participants enrolled in France (or in other countries as required by local regulations or Ethics Committee/Institutional Review Board \[IRB\]) who:
• •* Participated in any study using an investigational drug or vaccine during the previous 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine, whichever is longer, prior to screening for the study, or
• •* Participate simultaneously in another clinical study.