A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)

Conditions

• Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ISL — DRUG
  ISL 2 x 1 mg oral capsules administered qw for 96 weeks
• ULO — DRUG
  ULO 2 x 100 mg oral tablets administered qw for 96 weeks
• BIC/FTC/TAF — DRUG
  BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks
• Placebo for BIC/FTC/TAF — DRUG
  BIC/FTC/TAF-matching placebo oral tablet administered qd for 96 weeks
• Placebo to ISL/ULO — DRUG
  ISL/ULO-matching placebo oral tablets administered qw for 96 weeks
• ISL/ULO — DRUG
  ISL/ULO fixed-dose combination 2 mg/200 mg oral tablet administered qw for 96 weeks

Study Details

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.

Key Dates

Start date

Dec 18, 2025

Status verified

Jun 2026

Primary completion

Mar 21, 2029

Completion

Apr 3, 2030

Study Design

Enrollment

570 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 2: ISL + ULO
  Islatravir (ISL) 2mg and Ulonivirine (ULO) 200mg administered orally once weekly (qw) for 96 weeks
• Active Comparator: Phase 2: BIC/FTC/TAF
  Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) 50/200/25 mg, administered orally once daily (qd) for 96 weeks
• Experimental: Phase 3: ISL/ULO and Placebo to BIC/FTC/TAF
  ISL/ULO fixed dose combination (2/200 mg), administered orally qw, and matching placebo to BIC/FTC/TAF administered orally qd for 96 weeks
• Active Comparator: Phase 3: BIC/FTC/TAF and Placebo to ISL/ULO
  BIC/FTC/TAF 50/200/25 mg, administered orally qd, and matching placebo to ISL/ULO administered orally qw for 96 weeks

Primary Outcome Measure

Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24 [ Time Frame: Week 24 ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (24)

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