NCT07266831RecruitingPhase 2/3
A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 570 (estimated)
- First submitted
- 1 Dec 2025
- Start date
- 18 Dec 2025
- Primary completion date
- 1 Feb 2029
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- HIV
- NCT number
- NCT07266831
- EU CT number
- 2025-522519-40-00
- EudraCT number
- 2025-522519-40
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 570
- From 18 Dec 2025 to the primary completion date, 1 Feb 2029
- 68 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration any time prior to Day 1.
Other illness
- 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.
Age
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (68)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundación IDEAA ( Site 3101) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 3102) Coordinator of this site? Confirm its status | Caba | Argentina | Recruiting |
| Fundación Huesped ( Site 3100) Coordinator of this site? Confirm its status | CABA | Argentina | Recruiting |
| Instituto de Investigaciones Clinicas Mar del Plata ( Site 3103) Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Recruiting |
| Instituto CAICI SRL ( Site 3106) Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 3105) Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Recruiting |
| Gestion clinique médicale l'Actuel ( Site 3303) Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Spectrum Health ( Site 3307) Coordinator of this site? Confirm its status | Vancouver | Canada | Completed |
| Biomedica Research Group ( Site 4201) Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Clínica Universidad de Los Andes ( Site 4207) Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Espacio Eme ( Site 4202) Coordinator of this site? Confirm its status | Santiago | Chile | Active, not recruiting |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital General Universitario Santa Lucia Coordinator of this site? Confirm its status | Cartagena | Spain | Recruiting |
| Hospital General Universitario de Elche Coordinator of this site? Confirm its status | Elche | Spain | Recruiting |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Consorcio Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Bobigny Cedex | France | Recruiting |
| Pellegrin Hospital Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil | France | Recruiting |
| Hospital La Croix Rousse Hcl Coordinator of this site? Confirm its status | Lyon Cedex 04 | France | Recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Recruiting |
| Hospital Hotel Dieu Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Centre Hospitalier Universitaire de Nîmes Coordinator of this site? Confirm its status | Nîmes | France | Recruiting |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 18 | France | Recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Centre Hospitalier De Tourcoing Coordinator of this site? Confirm its status | Tourcoing Cedex | France | Recruiting |
| CELAN,S.A ( Site 3802) Coordinator of this site? Confirm its status | Guatemala City | Guatemala | Recruiting |
| Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 3801) Coordinator of this site? Confirm its status | Guatemala City | Guatemala | Recruiting |
| MEDI-K ( Site 3803) Coordinator of this site? Confirm its status | Guatemala City | Guatemala | Recruiting |
| Morales Vargas Centro de Investigacion, S.C. ( Site 4502) Coordinator of this site? Confirm its status | León | Mexico | Recruiting |
| Arké SMO S.A de C.V ( Site 4505) Coordinator of this site? Confirm its status | Veracruz | Mexico | Recruiting |
| Saint Hope Foundation, Inc. ( Site 1504) Coordinator of this site? Confirm its status | Bellaire | United States | Recruiting |
| Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533) Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Rush University Medical Center-Infectious Disease ( Site 1522) Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| The Ohio State University ( Site 1536) Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| North Texas Infectious Diseases Consultants ( Site 1500) Coordinator of this site? Confirm its status | Dallas | United States | Active, not recruiting |
| Prism Health North Texas, Oak Cliff Health Center ( Site 1514) Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Metro Infectious Diseases Consultants L.L.C. ( Site 1509) Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| Vivent Health ( Site 1519) Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Henry Ford Hospital ( Site 1535) Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Texas Center for Infectious Disease Associates ( Site 1502) Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Midway Immunology and Research Center ( Site 1503) Coordinator of this site? Confirm its status | Ft. Pierce | United States | Recruiting |
| Regional Center for Infectious Diseases ( Site 1516) Coordinator of this site? Confirm its status | Greensboro | United States | Recruiting |
| ID Care ( Site 1507) Coordinator of this site? Confirm its status | Hillsborough | United States | Recruiting |
| KC CARE Health Center ( Site 1506) Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| DCOL Center for Clinical Research ( Site 1511) Coordinator of this site? Confirm its status | Longview | United States | Recruiting |
| Ruane Clinical Research Group, Inc. ( Site 1513) Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Mercer university, Department of internal medicine-Clinical Research ( Site 1512) Coordinator of this site? Confirm its status | Macon | United States | Recruiting |
| CAN Community Health- Miami Gardens ( Site 1549) Coordinator of this site? Confirm its status | Miami Gardens | United States | Recruiting |
| Orlando Immunology Center ( Site 1501) Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| University of Pennsylvania Perelman School of Medicine ( Site 1508) Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| CAN Community Health ( Site 1510) Coordinator of this site? Confirm its status | Sarasota | United States | Recruiting |
| Harborview Medical Center ( Site 1526) Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Whitman-Walker Institute ( Site 1538) Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
| Triple O Research Institute ( Site 1505) Coordinator of this site? Confirm its status | West Palm Beach | United States | Recruiting |
| Josha Research ( Site 4302) Coordinator of this site? Confirm its status | Bloemfontein | South Africa | Recruiting |
| Wentworth Hospital ( Site 4303) Coordinator of this site? Confirm its status | Durban | South Africa | Recruiting |
| Be Part Yoluntu Centre ( Site 4300) Coordinator of this site? Confirm its status | Mbekweni, Paarl | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.