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NCT05766501 · ClinicalTrials.gov registry record · Phase 3
A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)
A Phase 3 study of HIV Infection, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 641
- Enrollment target
- 20
- Study locations
NCT05766501: Active Phase 3 study of HIV Infection, sponsored by Merck Sharp & Dohme.
NCT05766501 is a Phase 3 study of HIV Infection that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 641 participants, above the 234-participant average among 73 other HIV Infection trials with a reported enrollment target (174% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05766501, a Phase 3 study of HIV Infection, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 641 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE through Week 96 will be presented.
Conditions Studied
Interventions
- DRUG DOR/ISL
Study Locations (20)
Florida
- Therafirst Medical Center ( Site 3110) - Fort Lauderdale
- Midway Immunology and Research Center ( Site 3117) - Ft. Pierce
- AHF The Kinder Medical Group ( Site 3108) - Miami
- Floridian Clinical Research, LLC ( Site 3133) - Miami Lakes
- Orlando Immunology Center ( Site 3106) - Orlando
- Bliss Healthcare Services ( Site 3115) - Orlando
- CAN Community Health - Sarasota ( Site 3118) - Sarasota
- Triple O Research Institute, P.A ( Site 3116) - West Palm Beach
California
- Pacific Oaks Medical Group ( Site 3123) - Beverly Hills
- Kaiser Permanente ( Site 3124) - Los Angeles
- Ruane Clinical Research Group, Inc ( Site 3126) - Los Angeles
- Mills Clinical Research ( Site 3114) - Los Angeles
- University of California Davis Health-Internal Medicine: Infectious Diseases ( Site 3137) - Sacramento
Georgia
- Augusta University-Infectious Diseases ( Site 3135) - Augusta
- Infectious Disease Specialists of Atlanta ( Site 3128) - Decatur
- Mercer university, Department of internal medicine-Clinical Research ( Site 3129) - Macon
- Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3105) - Savannah
Alabama
- University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 3104) - Birmingham
Arizona
- Pueblo Family Physicians ( Site 3102) - Phoenix
District of Columbia
- Georgetown University Medical Center ( Site 3130) - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 641 participants |
| Start Date | 2023-03-17 |
| Est. Completion | 2028-09-06 |
| Phase | Phase 3 |
What the registry record for NCT05766501 still lists
NCT05766501 is an interventional study that assigns participants to a tested intervention. The registered 641 participants enrollment target is mid-sized for trials with a published cap, above the 234-participant average among 73 other HIV Infection trials with a reported enrollment target (174% higher).
The record links to 1 condition, with HIV Infection appearing as the primary indexed condition, and to 1 intervention - of which DOR/ISL is the first listed.
NCT05766501 names 20 study sites across 6 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT05766501 about?
NCT05766501 is a clinical study titled "A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)". The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.
What is the current status of trial NCT05766501?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 641 participants. The study started on 2023-03-17. Estimated completion is 2028-09-06.
What conditions does trial NCT05766501 study?
This clinical trial studies the following conditions: HIV Infection.
What interventions are being tested in trial NCT05766501?
The interventions under investigation include: DOR/ISL (DRUG).
Who is sponsoring clinical trial NCT05766501?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05766501 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT05766501's enrollment target sits among peer trials
641 7th of 73 higher than 67 of 73 other HIV Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV 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.
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