Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)

Completed · Phase 3

Conditions studied: HIV Infection

In brief

This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a protocol-specified antiretroviral regimen. The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with baseline antiretroviral therapy (ART) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.

Key facts

Study ID

NCT04223778

Run by

Merck Sharp & Dohme LLC

People needed

672

Starts

2020-02-18

Expected to finish

2024-08-26

Last updated by the study team

2026-02-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is human immunodeficiency virus (HIV-1) positive
• Has been receiving continuous, stable oral 2-drug or 3-drug combination (± pharmacokinetic (PK) booster) with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen.
• Females are eligible to participate if she is 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 an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before the first dose of study intervention; if a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive

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 an active diagnosis of hepatitis due to any cause, including active Hepatitis B Virus (HBV) co-infection
• 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
• Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies
• Is currently taking long-acting cabotegravir-rilpivirine
• 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 virologic resistance to doravirine (DOR)
• Expects to conceive or donate eggs at any time during the study

Where it is running

• Midway Immunology and Research ( Site 1030) — Ft. Pierce, Florida, United States
• Orlando Immunology Center ( Site 1007) — Orlando, Florida, United States
• Bliss Healthcare Services ( Site 1025) — Orlando, Florida, United States
• Triple O Research Institute, P.A. ( Site 1026) — West Palm Beach, Florida, United States
• Chatham County Health Department ( Site 1043) — Savannah, Georgia, United States
• Northstar Healthcare ( Site 1002) — Chicago, Illinois, United States
• Kansas City CARE Health Center ( Site 1008) — Kansas City, Missouri, United States
• ID Care ( Site 1023) — Hillsborough, New Jersey, United States
• University of North Carolina at Chapel Hill ( Site 1042) — Chapel Hill, North Carolina, United States
• University of Pennsylvania ( Site 1038) — Philadelphia, Pennsylvania, United States
• Saint Hope Foundation, Inc. ( Site 1037) — Bellaire, Texas, United States
• North Texas ID Consultants, PA ( Site 1003) — Dallas, Texas, United States
• Texas Centers for Infectious Disease Associates P.A. ( Site 1022) — Fort Worth, Texas, United States
• The Crofoot Research Center, Inc. ( Site 1005) — Houston, Texas, United States
• Holdsworth House Medical Practice ( Site 2300) — Sydney, New South Wales, Australia
• Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 2309) — Herston, Queensland, Australia
• Melbourne Sexual Health Centre ( Site 2305) — Carlton, Victoria, Australia
• Fiona Stanley Hospital ( Site 2301) — Murdoch, Western Australia, Australia
• Southern Alberta HIV Clinic ( Site 1108) — Calgary, Alberta, Canada
• Vancouver ID Research and Care Centre Society ( Site 1100) — Vancouver, British Columbia, Canada
• Hamilton Health Sciences ( Site 1103) — Hamilton, Ontario, Canada
• Maple Leaf Research ( Site 1112) — Toronto, Ontario, Canada
• Toronto General Hospital - University Health Network ( Site 1105) — Toronto, Ontario, Canada
• Clinique de Medecine Urbaine du Quartier Latin ( Site 1104) — Montreal, Quebec, Canada
• Georgetown University Hospital ( Site 1018) — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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