A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: HIV-1 Infection
In brief
The primary objectives of this study are to evaluate the antiretroviral activity of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) at Week 48; and to evaluate the safety and tolerability of a switch to DOR/ISL compared with continued BIC/FTC/TAF, through Week 48. The primary hypotheses are that (1) DOR/ISL is non-inferior to continued BIC/FTC/TAF, 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; and (2) DOR/ISL is superior to BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48.
Key facts
- Study ID
- NCT05630755
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 514
- Starts
- 2023-02-17
- Expected to finish
- 2028-08-04
- Last updated by the study team
- 2025-11-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL
- Has been receiving BIC/FTC/TAF therapy 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 participant of childbearing potential, not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration
You may not qualify if…
- Has HIV-2 infection
- 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 with laboratory values consistent with cirrhosis
- 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 cancer, or cutaneous Kaposi's sarcoma
- Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A) inducers
- Has a documented or known virologic resistance to DOR
- Has taken long-acting HIV therapy at any time (e.g., cabotegravir, lenacapavir)
- 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 except those currently enrolled in the comparator arm of an ongoing DOR/ISL study
Where it is running
- Pueblo Family Physicians ( Site 1425) — Phoenix, Arizona, United States
- Pacific Oaks Medical Group ( Site 1400) — Beverly Hills, California, United States
- Ruane Clinical Research Group, Inc ( Site 1414) — Los Angeles, California, United States
- Mills Clinical Research ( Site 1433) — Los Angeles, California, United States
- Whitman-Walker Institute ( Site 1431) — Washington D.C., District of Columbia, United States
- Therafirst Medical Center ( Site 1402) — Fort Lauderdale, Florida, United States
- Midway Immunology and Research Center ( Site 1401) — Ft. Pierce, Florida, United States
- AHF The Kinder Medical Group ( Site 1426) — Miami, Florida, United States
- Orlando Immunology Center ( Site 1407) — Orlando, Florida, United States
- Triple O Research Institute, P.A ( Site 1417) — West Palm Beach, Florida, United States
- Infectious Disease Specialists of Atlanta ( Site 1403) — Decatur, Georgia, United States
- Mercer University, Department of Internal Medicine ( Site 1411) — Macon, Georgia, United States
- AccessHealth MA ( Site 1419) — Boston, Massachusetts, United States
- Be Well Medical Center ( Site 1408) — Berkley, Michigan, United States
- KC CARE Health Center-Clinical Trials ( Site 1422) — Kansas City, Missouri, United States
- Las Vegas Research Center ( Site 1436) — Las Vegas, Nevada, United States
- Regional Center for Infectious Disease Research ( Site 1435) — Greensboro, North Carolina, United States
- Central Texas Clinical Research ( Site 1413) — Austin, Texas, United States
- St Hope Foundation ( Site 1410) — Bellaire, Texas, United States
- Prism Health North Texas, Oak Cliff Health Center ( Site 1409) — Dallas, Texas, United States
- North Texas Infectious Diseases Consultants, P.A ( Site 1404) — Dallas, Texas, United States
- Texas Centers for Infectious Disease Associates ( Site 1406) — Fort Worth, Texas, United States
- The Crofoot Research Center ( Site 1424) — Houston, Texas, United States
- DCOL Center for Clinical Research ( Site 1415) — Longview, Texas, United States
- Holdsworth House Medical Practice ( Site 6200) — Darlinghurst, New South Wales, Australia
Full record on ClinicalTrials.gov
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