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)
Public ClinicalTrials.gov record NCT04776252. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Open-label Rollover Clinical Study of Doravirine/Islatravir (DOR/ISL) Once-daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL in a Phase 2 or Phase 3 DOR/ISL Clinical Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04776252
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,000 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 14, 2021
- Primary completion
- May 28, 2029
- Completion
- May 28, 2029
- Last update posted
- Dec 22, 2025
2021 – 2029
United States locations
- U.S. sites
- 18
- U.S. states
- 11
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pueblo Family Physicians ( Site 0010) | Phoenix | Arizona | 85015 | — |
| One Community Health ( Site 0045) | Sacramento | California | 95811 | — |
| Whitman-Walker Institute ( Site 0039) | Washington D.C. | District of Columbia | 20005 | — |
| Georgetown University Medical Center-Clinical Trials Unit Division of Infectious Diseases ( Site 002 | Washington D.C. | District of Columbia | 20007 | — |
| Midway Immunology and Research Center ( Site 0033) | Ft. Pierce | Florida | 34982 | — |
| Orlando Immunology Center ( Site 0017) | Orlando | Florida | 32803 | — |
| Bliss Healthcare Services-Research ( Site 0030) | Orlando | Florida | 32806 | — |
| Triple O Research Institute, P.A ( Site 0031) | West Palm Beach | Florida | 33407 | — |
| Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 0015) | Savannah | Georgia | 31401 | — |
| Northstar Healthcare ( Site 0003) | Chicago | Illinois | 60657 | — |
| KC CARE Health Center-Clinical Trials ( Site 0012) | Kansas City | Missouri | 64111 | — |
| ID Care ( Site 0028) | Hillsborough | New Jersey | 08844 | — |
| Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 0006) | New York | New York | 10029 | — |
| Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site | Philadelphia | Pennsylvania | 19104 | — |
| St Hope Foundation ( Site 0041) | Bellaire | Texas | 77401 | — |
| North Texas Infectious Diseases Consultants, P.A-Research ( Site 0004) | Dallas | Texas | 75246 | — |
| Texas Center for Infectious Disease Associates-Clinical Research ( Site 0026) | Fort Worth | Texas | 76104 | — |
| The Crofoot Research Center ( Site 0008) | Houston | Texas | 77098 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 75 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04776252, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 22, 2025 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04776252 live on ClinicalTrials.gov.