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NCT05630755 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of HIV-1-infection, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 514
- Enrollment target
- 20
- Study locations
NCT05630755: Active Phase 3 study of HIV-1-infection, sponsored by Merck Sharp & Dohme.
NCT05630755 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 514 participants, above the 344-participant average among 71 other HIV-1-infection trials with a reported enrollment target (49% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05630755, 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
- 514 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
HIV-1 RNA levels in blood samples taken at each visit were measured with a reliable lower limit of quantification of \<50 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
Conditions Studied
Interventions
- DRUG BIC/FTC/TAF
- DRUG DOR/ISL
- DRUG Placebo to BIC/FTC/TAF
- DRUG Placebo to DOR/ISL
Study Locations (20)
Florida
- Therafirst Medical Center ( Site 1402) - Fort Lauderdale
- Midway Immunology and Research Center ( Site 1401) - Ft. Pierce
- AHF The Kinder Medical Group ( Site 1426) - Miami
- Orlando Immunology Center ( Site 1407) - Orlando
- Triple O Research Institute, P.A ( Site 1417) - West Palm Beach
California
- Pacific Oaks Medical Group ( Site 1400) - Beverly Hills
- Ruane Clinical Research Group, Inc ( Site 1414) - Los Angeles
- Mills Clinical Research ( Site 1433) - Los Angeles
Texas
- Central Texas Clinical Research ( Site 1413) - Austin
- St Hope Foundation ( Site 1410) - Bellaire
- Prism Health North Texas, Oak Cliff Health Center ( Site 1409) - Dallas
Georgia
- Infectious Disease Specialists of Atlanta ( Site 1403) - Decatur
- Mercer University, Department of Internal Medicine ( Site 1411) - Macon
Arizona
- Pueblo Family Physicians ( Site 1425) - Phoenix
District of Columbia
- Whitman-Walker Institute ( Site 1431) - Washington D.C.
Massachusetts
- AccessHealth MA ( Site 1419) - Boston
Michigan
- Be Well Medical Center ( Site 1408) - Berkley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 514 participants |
| Start Date | 2023-02-17 |
| Est. Completion | 2028-08-04 |
| Phase | Phase 3 |
What the registry record for NCT05630755 still lists
NCT05630755 is an interventional study that assigns participants to a tested intervention. The registered 514 participants enrollment target is mid-sized for trials with a published cap, above the 344-participant average among 71 other HIV-1-infection trials with a reported enrollment target (49% higher).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 4 interventions - of which BIC/FTC/TAF is the first listed.
NCT05630755 names 20 study sites across 11 states, led by Florida, California, Texas.
Frequently Asked Questions
What is clinical trial NCT05630755 about?
NCT05630755 is a clinical study titled "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)". 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 compare...
What is the current status of trial NCT05630755?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 514 participants. The study started on 2023-02-17. Estimated completion is 2028-08-04.
What conditions does trial NCT05630755 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT05630755?
The interventions under investigation include: BIC/FTC/TAF (DRUG), DOR/ISL (DRUG), Placebo to BIC/FTC/TAF (DRUG), Placebo to DOR/ISL (DRUG).
Who is sponsoring clinical trial NCT05630755?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05630755 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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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 NCT05630755's enrollment target sits among peer trials
514 14th of 71 higher than 58 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
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