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NCT07266831 · ClinicalTrials.gov registry record · Phase 2
A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
A Phase 2 study of Human Immunodeficiency Virus Type 1 (HIV-1) Infection, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 570
- Enrollment target
- 20
- Study locations
NCT07266831: Recruiting Phase 2 study of Human Immunodeficiency Virus Type 1 (HIV-1) Infection, sponsored by Merck Sharp & Dohme.
NCT07266831 is a Phase 2 study of Human Immunodeficiency Virus Type 1 (HIV-1) Infection that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 570 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (329% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07266831, a Phase 2 study of Human Immunodeficiency Virus Type 1 (HIV-1) Infection, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 570 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Plasma HIV-1 ribonucleic acid (RNA) quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay. Percentage of participants with HIV-1 RNA \<50 copies/mL will be reported at week 24.
Conditions Studied
Interventions
- DRUG ISL
- DRUG ULO
- DRUG BIC/FTC/TAF
- DRUG Placebo for BIC/FTC/TAF
- DRUG Placebo to ISL/ULO
Study Locations (20)
Florida
- Midway Immunology and Research Center ( Site 1503) - Ft. Pierce
- CAN Community Health- Miami Gardens ( Site 1549) - Miami
- Orlando Immunology Center ( Site 1501) - Orlando
- CAN Community Health ( Site 1510) - Sarasota
- Triple O Research Institute ( Site 1505) - West Palm Beach
Texas
- Saint Hope Foundation, Inc. ( Site 1504) - Bellaire
- Prism Health North Texas, Oak Cliff Health Center ( Site 1514) - Dallas
- North Texas Infectious Diseases Consultants ( Site 1500) - Dallas
- Texas Center for Infectious Disease Associates ( Site 1502) - Fort Worth
- DCOL Center for Clinical Research ( Site 1511) - Longview
Georgia
- Metro Infectious Diseases Consultants L.L.C. ( Site 1509) - Decatur
- Mercer university, Department of internal medicine-Clinical Research ( Site 1512) - Macon
Colorado
- Vivent Health ( Site 1519) - Denver
District of Columbia
- Whitman-Walker Institute ( Site 1538) - Washington D.C.
Missouri
- KC CARE Health Center ( Site 1506) - Kansas City
New Jersey
- ID Care ( Site 1507) - Hillsborough
North Carolina
- Regional Center for Infectious Diseases ( Site 1516) - Greensboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 570 participants |
| Start Date | 2025-12-18 |
| Est. Completion | 2030-04-25 |
| Phase | Phase 2 |
What NCT07266831 shows while recruiting
NCT07266831 is an interventional study that assigns participants to a tested intervention. The registered 570 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (329% higher).
The record links to 1 condition, with Human Immunodeficiency Virus Type 1 (HIV-1) Infection appearing as the primary indexed condition, and to 5 interventions - of which ISL is the first listed.
NCT07266831 names 20 study sites across 11 states, led by Florida, Texas, Georgia.
Frequently Asked Questions
What is clinical trial NCT07266831 about?
NCT07266831 is a clinical study titled "A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)". 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 u...
What is the current status of trial NCT07266831?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 570 participants. The study started on 2025-12-18. Estimated completion is 2030-04-25.
What conditions does trial NCT07266831 study?
This clinical trial studies the following conditions: Human Immunodeficiency Virus Type 1 (HIV-1) Infection.
What interventions are being tested in trial NCT07266831?
The interventions under investigation include: ISL (DRUG), ULO (DRUG), BIC/FTC/TAF (DRUG), Placebo for BIC/FTC/TAF (DRUG), Placebo to ISL/ULO (DRUG).
Who is sponsoring clinical trial NCT07266831?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07266831 being conducted?
This trial has 20 study locations across Colorado, District of Columbia, Florida, Georgia, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07266831's enrollment target sits among peer trials
570 60th of 2000 higher than 1,941 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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