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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04776252
The ClinicalTrials.gov registry entry for NCT04776252 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 323-participant average among 71 other HIV-1-infection trials with a reported enrollment target (519% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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
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Read our methodology - how this data is sourced, computed, and verified.
Related
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