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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: Active Phase 3 study of HIV-1-infection, sponsored by Merck Sharp & Dohme.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Plasma HIV-1 RNA quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay with a lower limit of detection of \<50 copies/mL.

Conditions Studied

HIV-1-infection

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

FieldValue
Enrollment Target 537 participants
Start Date 2023-03-08
Est. Completion 2029-08-05
Phase Phase 3
Merck Sharp & Dohme

558 total trials

What the registry record for NCT05705349 still lists

NCT05705349 is an interventional study that assigns participants to a tested intervention. The registered 537 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 (56% 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.

NCT05705349 names 20 study sites across 8 states, led by 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.

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 NCT05705349's enrollment target sits among peer trials

537 13th of 71 higher than 59 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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Related registry views

Source: ClinicalTrials.gov NCT05705349, the US trial registry maintained by the National Library of Medicine. NCT05705349 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.