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of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly Compared With Bictegravir\u002FEmtricitabine\u002FTenofovir Alafenamide (BIC\u002FFTC\u002FTAF) Once Daily in Treatment-Naïve Adult Participants Living With HIV-1","Inclusion Criteria:\n\n* Phase 2: Is human immunodeficiency virus type 1 (HIV-1) positive with Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies\u002FmL.\n* Phase 3: Is HIV-1 positive with Plasma HIV-1 RNA ≥500 copies\u002FmL.\n* Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥200 cells\u002Fmm\\^3.\n* Is naïve to antiretroviral therapy (ART), defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection.\n\nExclusion Criteria:\n\n* Has human immunodeficiency virus type 2 (HIV-2) infection.\n* Has a diagnosis of an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection.\n* Has active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection.\n* Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or in situ anal cancer, or cutaneous Kaposi's sarcoma.\n* Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration any time prior to Day 1.","ALL","18 Years",{"count":776,"type":777},570,"ESTIMATED","INTERVENTIONAL",[780,781],"PHASE2","PHASE3","Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a study ART works as well as a standard ART to treat HIV-1. The study ART combines 2 medicines, islatravir and ulonivirine, and is taken once a week. The goals of this study are to learn: 1) If the study ART works as well as a standard ART to treat HIV-1, and 2) About the safety of the study ART and if people tolerate it compared to a standard ART.",[784],"Human Immunodeficiency Virus Type 1 (HIV-1) Infection","2026-06-04",{"date":787,"type":788},"2026-06-08","ACTUAL",{"date":790,"type":788},"2025-12-18",{"date":792,"type":777},"2030-04-03",{"name":5,"class":6},56]