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NCT04776252 · ClinicalTrials.gov registry record · Phase 3
Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)
A Phase 3 study of HIV-1-infection, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 2,000
- Enrollment target
- 20
- Study locations
NCT04776252: Active Phase 3 study of HIV-1-infection, sponsored by Merck Sharp & Dohme.
NCT04776252 is a Phase 3 study of HIV-1-infection that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 2,000 participants, above the 323-participant average among 71 other HIV-1-infection trials with a reported enrollment target (519% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04776252, a Phase 3 study of HIV-1-infection, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 2,000 participants
- Enrollment target
- 20
- Study locations
Study Summary
The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine (100mg) and islatravir (0.75mg) \[DOR/ISL 100 mg/0.75 mg) will be evaluated in participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.
Primary Outcome
Percentage of participants with serious adverse events (SAEs)
Conditions Studied
Interventions
- DRUG MK-8591A
Study Locations (20)
Florida
- Midway Immunology and Research Center ( Site 0033) - Ft. Pierce
- Orlando Immunology Center ( Site 0017) - Orlando
- Bliss Healthcare Services-Research ( Site 0030) - Orlando
- Triple O Research Institute, P.A ( Site 0031) - West Palm Beach
Texas
- St Hope Foundation ( Site 0041) - Bellaire
- North Texas Infectious Diseases Consultants, P.A-Research ( Site 0004) - Dallas
- Texas Center for Infectious Disease Associates-Clinical Research ( Site 0026) - Fort Worth
- The Crofoot Research Center ( Site 0008) - Houston
District of Columbia
- Whitman-Walker Institute ( Site 0039) - Washington D.C.
- Georgetown University Medical Center-Clinical Trials Unit Division of Infectious Diseases ( Site 002 - Washington D.C.
New South Wales
- Holdsworth House Medical Practice ( Site 0700) - Darlinghurst
- St Vincent's Hospital-IBAC ( Site 0702) - Sydney
Arizona
- Pueblo Family Physicians ( Site 0010) - Phoenix
California
- One Community Health ( Site 0045) - Sacramento
Georgia
- Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 0015) - Savannah
Illinois
- Northstar Healthcare ( Site 0003) - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2021-09-15 |
| Est. Completion | 2029-05-29 |
| Phase | Phase 3 |
What the registry record for NCT04776252 still lists
NCT04776252 is an interventional study that assigns participants to a tested intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus, above the 323-participant average among 71 other HIV-1-infection trials with a reported enrollment target (519% higher).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 1 intervention - of which MK-8591A is the first listed.
NCT04776252 names 20 study sites across 12 states, led by Florida, Texas, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT04776252 about?
NCT04776252 is a clinical study titled "Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)". The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine (100mg) and islatravir (0.75mg) \[DOR/ISL 100 mg/0.75 mg) will be evaluated in participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.
What is the current status of trial NCT04776252?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 2,000 participants. The study started on 2021-09-15. Estimated completion is 2029-05-29.
What conditions does trial NCT04776252 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT04776252?
The interventions under investigation include: MK-8591A (DRUG).
Who is sponsoring clinical trial NCT04776252?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04776252 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV-1-infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04776252's enrollment target sits among peer trials
2,000 2nd of 71 the highest of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
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Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1
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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)
ACTIVE NOT RECRUITING · Phase 3
-
DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)
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-
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)
ACTIVE NOT RECRUITING · Phase 3
-
Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1
ACTIVE NOT RECRUITING · Phase 3
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