Actively Recruiting
A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-12
570
Participants Needed
53
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Phase 2: HIV-1 positive with plasma HIV-1 RNA between 500 and 100,000 copies/mL
- Phase 3: HIV-1 positive with plasma HIV-1 RNA of at least 500 copies/mL
- Phase 2: CD4+ T-cell count of at least 200 cells/mm3
- Nafve to antiretroviral therapy (no prior ART treatment for HIV-1)
You will not qualify if you...
- Has HIV-2 infection
- Has an active AIDS-defining opportunistic infection
- Has active hepatitis B or hepatitis C infection
- Has a history of cancer within 5 years before consent, except for certain treated skin cancers, in situ cervical or anal cancer, or cutaneous Kaposi's sarcoma
- Has prior exposure to islatravir or ulonivirine before Day 1
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 53 locations
1
Ruane Clinical Research Group, Inc. ( Site 1513)
Los Angeles, California, United States, 90036
Actively Recruiting
2
Vivent Health ( Site 1519)
Denver, Colorado, United States, 80246
Actively Recruiting
3
Whitman-Walker Institute ( Site 1538)
Washington D.C., District of Columbia, United States, 20032
Actively Recruiting
4
Midway Immunology and Research Center ( Site 1503)
Ft. Pierce, Florida, United States, 34982
Actively Recruiting
5
CAN Community Health- Miami Gardens ( Site 1549)
Miami Gardens, Florida, United States, 33055
Actively Recruiting
6
Orlando Immunology Center ( Site 1501)
Orlando, Florida, United States, 32803
Actively Recruiting
7
CAN Community Health ( Site 1510)
Sarasota, Florida, United States, 34237
Actively Recruiting
8
Triple O Research Institute ( Site 1505)
West Palm Beach, Florida, United States, 33407
Actively Recruiting
9
Metro Infectious Diseases Consultants L.L.C. ( Site 1509)
Decatur, Georgia, United States, 30033
Actively Recruiting
10
Mercer university, Department of internal medicine-Clinical Research ( Site 1512)
Macon, Georgia, United States, 31201
Actively Recruiting
11
Henry Ford Hospital ( Site 1535)
Detroit, Michigan, United States, 48202
Actively Recruiting
12
KC CARE Health Center ( Site 1506)
Kansas City, Missouri, United States, 64111
Actively Recruiting
13
ID Care ( Site 1507)
Hillsborough, New Jersey, United States, 08844
Actively Recruiting
14
Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533)
Charlotte, North Carolina, United States, 28204
Actively Recruiting
15
Regional Center for Infectious Diseases ( Site 1516)
Greensboro, North Carolina, United States, 27401
Actively Recruiting
16
The Ohio State University ( Site 1536)
Columbus, Ohio, United States, 43210
Actively Recruiting
17
University of Pennsylvania Perelman School of Medicine ( Site 1508)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
18
Saint Hope Foundation, Inc. ( Site 1504)
Bellaire, Texas, United States, 77401
Actively Recruiting
19
Prism Health North Texas, Oak Cliff Health Center ( Site 1514)
Dallas, Texas, United States, 75208
Actively Recruiting
20
North Texas Infectious Diseases Consultants ( Site 1500)
Dallas, Texas, United States, 75246
Actively Recruiting
21
Texas Center for Infectious Disease Associates ( Site 1502)
Fort Worth, Texas, United States, 76104
Actively Recruiting
22
DCOL Center for Clinical Research ( Site 1511)
Longview, Texas, United States, 75605
Actively Recruiting
23
Harborview Medical Center ( Site 1526)
Seattle, Washington, United States, 98104
Actively Recruiting
24
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 3102)
Caba, Buenos Aires, Argentina, C1425AGC
Actively Recruiting
25
Fundación Huesped ( Site 3100)
CABA, Buenos Aires, Argentina, C1427CEA
Actively Recruiting
26
Instituto de Investigaciones Clinicas Mar del Plata ( Site 3103)
Mar del Plata, Buenos Aires, Argentina, B7600FZN
Actively Recruiting
27
Fundación IDEAA ( Site 3101)
Buenos Aires, Buenos Aires F.D., Argentina, C1405CKC
Actively Recruiting
28
Instituto CAICI SRL ( Site 3106)
Rosario, Santa Fe Province, Argentina, S2000PBJ
Actively Recruiting
29
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 3105)
San Miguel de Tucumán, Tucumán Province, Argentina, T4000IHE
Actively Recruiting
30
Spectrum Health ( Site 3307)
Vancouver, British Columbia, Canada, V6Z 2T1
Actively Recruiting
31
Gestion clinique médicale l'Actuel ( Site 3303)
Montreal, Quebec, Canada, H2L 4P9
Actively Recruiting
32
Biomedica Research Group ( Site 4201)
Santiago, Region M. de Santiago, Chile, 7500710
Actively Recruiting
33
Clínica Universidad de Los Andes ( Site 4207)
Santiago, Region M. de Santiago, Chile, 7620157
Actively Recruiting
34
Bordeaux University Hospital - Pellegrin ( Site 3605)
Bordeaux, Gironde, France, 33000
Actively Recruiting
35
Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan ( Site 3608)
Toulouse, Haute-Garonne, France, 31059
Actively Recruiting
36
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Infectious Disease ( Site 3606)
Nantes, Pays de la Loire Region, France, 44093
Actively Recruiting
37
HOPITAL DE LA CROIX ROUSSE ( Site 3613)
Lyon, Rhone, France, 69317
Actively Recruiting
38
Hôpital Avicenne ( Site 3602)
Bobigny, Île-de-France Region, France, 93000
Actively Recruiting
39
Hôpital Saint-Louis ( Site 3600)
Paris, Île-de-France Region, France, 75010
Actively Recruiting
40
Hôpital Bichat - Claude-Bernard ( Site 3601)
Paris, Île-de-France Region, France, 75018
Actively Recruiting
41
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 3801)
Guatemala City, Guatemala, 01009
Actively Recruiting
42
MEDI-K ( Site 3803)
Guatemala City, Guatemala, 01009
Actively Recruiting
43
CELAN,S.A ( Site 3802)
Guatemala City, Guatemala, 01010
Actively Recruiting
44
Morales Vargas Centro de Investigacion, S.C. ( Site 4502)
León, Guanajuato, Mexico, 37000
Actively Recruiting
45
Arké SMO S.A de C.V ( Site 4505)
Veracruz, Mexico, 91910
Actively Recruiting
46
Wentworth Hospital ( Site 4303)
Durban, KwaZulu-Natal, South Africa, 4052
Actively Recruiting
47
Be Part Yoluntu Centre ( Site 4300)
Mbekweni, Paarl, Western Cape, South Africa, 7646
Actively Recruiting
48
Hospital Universitario La Paz ( Site 3404)
Madrid, Madrid, Comunidad de, Spain, 28029
Actively Recruiting
49
Consorcio Hospital General Universitario de Valencia ( Site 3406)
Valencia, Valenciana, Comunitat, Spain, 46014
Actively Recruiting
50
Hospital Universitari Vall d'Hebron ( Site 3402)
Barcelona, Spain, 08035
Actively Recruiting
51
HOSPITAL CLÍNIC DE BARCELONA ( Site 3400)
Barcelona, Spain, 08036
Actively Recruiting
52
Hospital Universitario 12 de Octubre ( Site 3405)
Madrid, Spain, 28041
Actively Recruiting
53
Complejo Hospitalario Virgen De La Victoria ( Site 3409)
Málaga, Spain, 29010
Actively Recruiting
Research Team
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Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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