Tests a once-weekly HIV pill combination in adults not yet treated
Tests islatravir and ulonivirine, taken weekly, against a daily standard HIV treatment.
Plain-language title generated from the registry record
Registry title: A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
Key facts
- Where
- Montreal and Vancouver, CanadaSee the 2 sites
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with HIV-1 who have never taken HIV medicines. It compares a once-weekly two-medicine treatment with a once-daily standard treatment.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- HIV-1 infection with plasma HIV-1 RNA ≥500 and ≤100,000 copies/mL in Phase 2, or ≥500 and ≤1,000,000 copies/mL in Phase 3. In Phase 2, CD4+ T-cell count must be ≥200 cells/mm^3.
- Earlier treatment
- People must never have taken any HIV medicine (antiretroviral therapy) since their HIV-1 diagnosis. They must not have taken islatravir (ISL) or ulonivirine (ULO) before.
- Biomarker or test result
- HIV-1 positive, with plasma HIV-1 RNA in the range given above.
Main reasons for not taking part
- HIV-2 infection
- Active AIDS-defining opportunistic infection
- Active hepatitis C or hepatitis B infection
- Cancer within the 5 years before consent (some skin, cervical and anal cancers and cutaneous Kaposi's sarcoma are allowed)
- Earlier use of islatravir (ISL) or ulonivirine (ULO)
Read by machine on 9 November 2026.
Where in Canada
- Gestion clinique médicale l'Actuel (Site 3303)Montreal, CanadaTaking people
- Spectrum Health (Site 3307)Vancouver, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT07266831EU 2025-522519-40-00
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 2/3, Randomized, Active-Controlled, Open-Label (Phase 2) and Double-Blind (Phase 3) Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily in Treatment-Naïve Adult Participants Living With HIV-1
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.
Inclusion: Phase 2: Is human immunodeficiency virus type 1 (HIV-1) positive with Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies/mL; Phase 3: Is HIV-1 positive with Plasma HIV-1 RNA ≥500 and ≤1,000,000 copies/mL; Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥200 cells/mm\^3; Is naïve to antiretroviral therapy (ART), defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection.
Exclusion: Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration any time prior to Day 1; Has human immunodeficiency virus type 2 (HIV-2) infection; Has a diagnosis of an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection; Has active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection; 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.