A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
Public ClinicalTrials.gov record NCT07266831. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07266831
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 570 participants
Conditions and interventions
Interventions
- ISL Drug
- ULO Drug
- BIC/FTC/TAF Drug
- Placebo for BIC/FTC/TAF Drug
- Placebo to ISL/ULO Drug
- ISL/ULO Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 17, 2025
- Primary completion
- Mar 20, 2029
- Completion
- Apr 2, 2030
- Last update posted
- Aug 9, 2026
2025 – 2030
United States locations
- U.S. sites
- 24
- U.S. states
- 14
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ruane Clinical Research Group, Inc. ( Site 1513) | Los Angeles | California | 90036 | Recruiting |
| Vivent Health ( Site 1519) | Denver | Colorado | 80246 | Recruiting |
| Whitman-Walker Institute ( Site 1538) | Washington D.C. | District of Columbia | 20032 | Recruiting |
| Midway Immunology and Research Center ( Site 1503) | Ft. Pierce | Florida | 34982 | Recruiting |
| CAN Community Health- Miami Gardens ( Site 1549) | Miami Gardens | Florida | 33055 | Recruiting |
| Orlando Immunology Center ( Site 1501) | Orlando | Florida | 32803 | Recruiting |
| CAN Community Health ( Site 1510) | Sarasota | Florida | 34237 | Recruiting |
| Triple O Research Institute ( Site 1505) | West Palm Beach | Florida | 33407 | Recruiting |
| Metro Infectious Diseases Consultants L.L.C. ( Site 1509) | Decatur | Georgia | 30033 | Recruiting |
| Mercer university, Department of internal medicine-Clinical Research ( Site 1512) | Macon | Georgia | 31201 | Recruiting |
| Rush University Medical Center-Infectious Disease ( Site 1522) | Chicago | Illinois | 60612 | Recruiting |
| Henry Ford Hospital ( Site 1535) | Detroit | Michigan | 48202 | Recruiting |
| KC CARE Health Center ( Site 1506) | Kansas City | Missouri | 64111 | Recruiting |
| ID Care ( Site 1507) | Hillsborough | New Jersey | 08844 | Recruiting |
| Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533) | Charlotte | North Carolina | 28204 | Recruiting |
| Regional Center for Infectious Diseases ( Site 1516) | Greensboro | North Carolina | 27401 | Recruiting |
| The Ohio State University ( Site 1536) | Columbus | Ohio | 43210 | Recruiting |
| University of Pennsylvania Perelman School of Medicine ( Site 1508) | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Saint Hope Foundation, Inc. ( Site 1504) | Bellaire | Texas | 77401 | Recruiting |
| Prism Health North Texas, Oak Cliff Health Center ( Site 1514) | Dallas | Texas | 75208 | Recruiting |
| North Texas Infectious Diseases Consultants ( Site 1500) | Dallas | Texas | 75246 | Active, not recruiting |
| Texas Center for Infectious Disease Associates ( Site 1502) | Fort Worth | Texas | 76104 | Recruiting |
| DCOL Center for Clinical Research ( Site 1511) | Longview | Texas | 75605 | Recruiting |
| Harborview Medical Center ( Site 1526) | Seattle | Washington | 98104 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 31 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07266831, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 9, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07266831 live on ClinicalTrials.gov.