A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051)
Running, not enrolling · Phase 3
Conditions studied: HIV-1 Infection
In brief
The primary objectives of this study are to evaluate the safety and tolerability of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued baseline antiretroviral therapy (ART), through Week 48; and to evaluate the antiretroviral activity of a switch to DOR/ISL compared with continued baseline ART at Week 48. The primary hypothesis is that DOR/ISL is non-inferior to continued baseline ART, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority.
Key facts
- Study ID
- NCT05631093
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 553
- Starts
- 2023-02-20
- Expected to finish
- 2028-07-11
- Last updated by the study team
- 2025-11-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Is Human Immunodeficiency Virus-1 (HIV-1) positive with plasma HIV-1 Ribonucleic Acid (RNA) <50 copies/mL at screening
- Has been receiving continuous, stable oral 2-drug or 3-drug combination (± PK booster) antiretroviral therapy ART with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen
- Female is not a participant of childbearing potential (POCBP); or if a POCBP uses an acceptable contraceptive method or abstains from penile-vaginal intercourse as their preferred and usual lifestyle; has a negative highly sensitive pregnancy test; and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator
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 a diagnosis of an active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 30 days prior to screening
- Has active hepatitis B virus (HBV) infection
- Has chronic hepatitis C virus (HCV) infection consistent with cirrhosis
- Has a ≤5 years prior history of malignancy
- Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A) inducers
- Has taken long-acting HIV therapy at any time
- Is currently participating in or has participated in a clinical study and received (or is receiving) 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 Doravine (DOR)
Where it is running
- Palmtree Clinical Research ( Site 3032) — Palm Springs, California, United States
- Zuckerberg San Francisco General Hospital and Trauma Center-UCSF ID Clinical Trials Center ( Site 30 — San Francisco, California, United States
- Georgetown University Medical Center ( Site 3006) — Washington D.C., District of Columbia, United States
- Midway Immunology and Research Center ( Site 3009) — Ft. Pierce, Florida, United States
- Orlando Immunology Center ( Site 3004) — Orlando, Florida, United States
- CAN Community Health - Sarasota ( Site 3017) — Sarasota, Florida, United States
- Triple O Research Institute, P.A ( Site 3026) — West Palm Beach, Florida, United States
- Infectious Disease Specialists of Atlanta ( Site 3003) — Decatur, Georgia, United States
- Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3028) — Savannah, Georgia, United States
- ID Care ( Site 3041) — Hillsborough, New Jersey, United States
- Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site — Philadelphia, Pennsylvania, United States
- Central Texas Clinical Research ( Site 3015) — Austin, Texas, United States
- The Crofoot Research Center ( Site 3040) — Houston, Texas, United States
- DCOL Center for Clinical Research ( Site 3022) — Longview, Texas, United States
- Holdsworth House Medical Practice ( Site 4200) — Darlinghurst, New South Wales, Australia
- St Vincent's Hospital-IBAC ( Site 4203) — Sydney, New South Wales, Australia
- Holdsworth House Medical Practice - Brisbane ( Site 4201) — Brisbane, Queensland, Australia
- Royal Brisbane and Women's Hospital-Infectious Diseases Research ( Site 4204) — Brisbane, Queensland, Australia
- Prahran Market Clinic ( Site 4202) — Melbourne, Victoria, Australia
- Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 3104) — Hamilton, Ontario, Canada
- Maple Leaf Research ( Site 3103) — Toronto, Ontario, Canada
- Toronto General Hospital ( Site 3102) — Toronto, Ontario, Canada
- Clinique de médecine Urbaine du Quartier Latin ( Site 3101) — Montreal, Quebec, Canada
- Clinique Medicale lActuel-Clinical Research ( Site 3100) — Montreal, Quebec, Canada
- Kaiser Permanente-Infectious Disease ( Site 3014) — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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