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NCT05705349 · ClinicalTrials.gov registry record · Phase 3
DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)
A Phase 3 study of HIV-1-infection, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 537
- Enrollment target
- 20
- Study locations
NCT05705349 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 537 participants, above the 344-participant average among 71 other HIV-1-infection trials with a reported enrollment target (56% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT05705349, 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
- 537 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL \[MK-8591A\]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.
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
- Midway Immunology and Research Center ( Site 5657) - Ft. Pierce
- AHF The Kinder Medical Group ( Site 5672) - Miami
- AHF South Beach ( Site 5663) - Miami Beach
- Orlando Immunology Center ( Site 5654) - Orlando
- CAN Community Health - Sarasota ( Site 5668) - Sarasota
- Triple O Research Institute, P.A ( Site 5666) - West Palm Beach
Georgia
- Emory University and Grady Health System-Medicine ( Site 5690) - Atlanta
- Emory University Hospital Midtown Infectious Disease Clinic ( Site 5673) - Atlanta
- Atlanta I.D. Group ( Site 5680) - Atlanta
- Metro Infectious Diseases Consultants L.L.C. ( Site 5653) - Decatur
- Mercer University, Department of Internal Medicine ( Site 5655) - Macon
Illinois
- Rush University Medical Center-Infectious Disease ( Site 5671) - Chicago
- University of Illinois at Chicago-Project WISH ( Site 5685) - Chicago
- Howard Brown Health Center-Clinical Research ( Site 5665) - Chicago
California
- Pacific Oaks Medical Group ( Site 5681) - Beverly Hills
- Ruane Clinical Research Group, Inc ( Site 5658) - Los Angeles
Arizona
- Pueblo Family Physicians ( Site 5674) - Phoenix
Colorado
- Vivent Health ( Site 5694) - Denver
District of Columbia
- Washington Health Institute ( Site 5689) - Washington D.C.
Michigan
- Be Well Medical Center ( Site 5650) - Berkley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 537 participants |
| Start Date | 2023-03-08 |
| Est. Completion | 2029-08-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05705349
The ClinicalTrials.gov registry entry for NCT05705349 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 537 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 344-participant average among 71 other HIV-1-infection trials with a reported enrollment target (56% 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 4 interventions - of which BIC/FTC/TAF is the first listed.
NCT05705349 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, Georgia, Illinois.
Frequently Asked Questions
What is clinical trial NCT05705349 about?
NCT05705349 is a clinical study titled "DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)". This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL \[MK-8591A\]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesiz...
What is the current status of trial NCT05705349?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 537 participants. The study started on 2023-03-08. Estimated completion is 2029-08-05.
What conditions does trial NCT05705349 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT05705349?
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 NCT05705349?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05705349 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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