A Phase 3b Multi-center, Open Label, Single Arm, 52-week Study, Evaluating the Feasibility, Efficacy and Safety of Rapid Test and Treat Intervention in Newly Diagnosed HIV-1 Infected Adults Using a Fixed Dose Combination of Dolutegravir Plus Lamivudine (DOVATO) as a First Line Regimen

Early initiation of antiretroviral therapy (ART) reduces morbidity and mortality for
individuals infected with HIV. Suppressing viral replication with ART also reduces the
potential for transmission of HIV. Hence, ART is recommended for all persons with HIV viremia
regardless of cluster of differentiation 4 (CD4) count. This is an open-label single arm
which will evaluate the feasibility, efficacy and safety using a fixed dose combination (FDC)
of Dolutegravir (DTG) plus Lamivudine (3TC) as a first line regimen of a rapid Test and Treat
model of care over 48 weeks. Participants with new and confirmed diagnosed HIV-1 who are
willing to start study treatment immediately following diagnosis will receive 50 milligram
(mg) DTG + 300 (mg) 3TC FDC as first line therapy without waiting for screening laboratory
results, at the Screening/Day 1 Visit. The total duration for the study will be 52 weeks and
4 weeks of follow up period if required. This study will be conducted in United States (US)
with approximately 120 participants.