Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]
Completed · Phase 2 · Has a placebo group
Conditions studied: HIV-1 Infection
In brief
This is a randomized, controlled, double-blind, study to evaluate the safety and tolerability of islatravir (ISL) + ulonivirine based on review of the accumulated safety data, in adult participants with human immunodeficiency virus type 1 (HIV-1) who have been virologically suppressed for ≥6 months on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) once-daily.
Key facts
- Study ID
- NCT04564547
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 161
- Starts
- 2021-03-09
- Expected to finish
- 2025-01-30
- Last updated by the study team
- 2026-01-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Is HIV-1 positive with plasma human immunodeficiency virus type 1 (HIV-1) RNA <50 copies/mL at screening
- Has been virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) for ≥6 months
- Has a screening CD4+ T-cell count >200 cells/mm\^3 (completed by the central laboratory)
- Is male or female, at least 18 years of age, at the time of signing the informed consent
- Female participants are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP)
- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis)
You may not qualify if…
- Has HIV-2 infection
- Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
- Has active hepatitis C virus (HCV) coinfection (defined as detectable HCV RNA) or hepatitis B virus (HBV) coinfection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA] positive)
- Has a current (active) diagnosis of acute hepatitis due to any cause
- Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
- Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study
- Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies
- Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period
- Has a documented or known virological resistance to ulonivirine or nucleoside/nucleotide reverse transcriptase inhibitors (NNRTI)
- Is female and expecting to conceive or donate eggs at any time during the study
Where it is running
- Pueblo Family Physicians ( Site 2702) — Phoenix, Arizona, United States
- Men's Health Foundation ( Site 2710) — Los Angeles, California, United States
- Midway Immunology and Research ( Site 2713) — Ft. Pierce, Florida, United States
- Triple O Research Institute, P.A. ( Site 2712) — West Palm Beach, Florida, United States
- Infectious Disease Specialists Of Atlanta PC ( Site 2704) — Decatur, Georgia, United States
- Chatham County Health Department ( Site 2707) — Savannah, Georgia, United States
- Kansas City CARE Clinic ( Site 2703) — Kansas City, Missouri, United States
- Saint Hope Foundation, Inc. ( Site 2716) — Bellaire, Texas, United States
- Texas Centers for Infectious Disease Associates P.A. ( Site 2709) — Fort Worth, Texas, United States
- DCOL Center for Clinical Research ( Site 2715) — Longview, Texas, United States
- CHU de Toulouse - Hopital Purpan ( Site 2302) — Toulouse, Haute-Garonne, France
- Hopital Gui de Chauliac. ( Site 2303) — Montpellier, Herault, France
- CHU Hotel Dieu Nantes ( Site 2310) — Nantes, Loire-Atlantique, France
- Centre Hospitalier Regional du Orleans ( Site 2304) — Orléans, Loiret, France
- Hopital Avicenne ( Site 2305) — Bobigny, Seine-Saint-Denis, France
- Hopital Saint Louis ( Site 2308) — Paris, France
- Hopital Saint-Antoine ( Site 2307) — Paris, France
- Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 2306) — Paris, Île-de-France Region, France
- Universitaetsspital Zuerich ( Site 2601) — Zuerich, Canton of Aargau, Switzerland
- Universitaetsspital Basel ( Site 2602) — Basel, Canton of Basel-City, Switzerland
- Inselspital Universitaetsspital Bern ( Site 2603) — Bern, Canton of Bern, Switzerland
- Hopitaux Universitaires de Geneve HUG ( Site 2604) — Geneva, Canton of Geneva, Switzerland
- CHUV (centre hospitalier universitaire vaudois) ( Site 2605) — Lausanne, Canton of Vaud, Switzerland
Full record on ClinicalTrials.gov
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