Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)
Public ClinicalTrials.gov record NCT04233216. 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, Randomized, Clinical Study in HIV-1-Infected Heavily Treatment-Experienced Participants Evaluating the Antiretroviral Activity of Blinded Islatravir (ISL), Doravirine (DOR), and Doravirine/Islatravir (DOR/ISL), Each Compared to Placebo, and the Antiretroviral Activity, Safety, and Tolerability of Open-Label DOR/ISL
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose combination (FDC) of DOR/ISL (also known as MK-8591A) in heavily treatment-experienced (HTE) participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that the percentage of participants receiving DOR/ISL to achieve ≥0.5 log10 decrease in HIV-1 ribonucleic acid (RNA) from study baseline (Day 1) to Day 8 is superior to placebo, each given in combination with failing antiretroviral therapy (ART).
Study identification
- NCT ID
- NCT04233216
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 35 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- 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
- Mar 17, 2020
- Primary completion
- Nov 20, 2022
- Completion
- Oct 31, 2023
- Last update posted
- Dec 26, 2024
2020 – 2023
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham 1917 Research Clinic ( Site 4031) | Birmingham | Alabama | 35222 | — |
| Men's Health Foundation ( Site 4018) | Los Angeles | California | 90069 | — |
| Palmtree Clinical Research, Inc. ( Site 4016) | Palm Springs | California | 92262 | — |
| Yale School of Medicine ( Site 4007) | New Haven | Connecticut | 06510 | — |
| Georgetown University Hospital ( Site 4015) | Washington D.C. | District of Columbia | 20007 | — |
| The Kinder Medical Group ( Site 4014) | Miami | Florida | 33133 | — |
| Orlando Immunology Center ( Site 4012) | Orlando | Florida | 32803 | — |
| Triple O Research Institute, P.A. ( Site 4020) | West Palm Beach | Florida | 33407 | — |
| Chatham County Health Department ( Site 4029) | Savannah | Georgia | 31410 | — |
| Howard Brown Health Center ( Site 4006) | Chicago | Illinois | 60613 | — |
| Northstar Healthcare ( Site 4004) | Chicago | Illinois | 60657 | — |
| University of Maryland ( Site 4023) | Baltimore | Maryland | 21201 | — |
| The University of Mississippi Medical Center ( Site 4036) | Jackson | Mississippi | 39216 | — |
| Saint Michael's Medical Center-Research - Infectious Disease ( Site 4035) | Newark | New Jersey | 07102 | — |
| Icahn School of Medicine at Mount Sinai ( Site 4000) | New York | New York | 10029 | — |
| University of North Carolina at Chapel Hill ( Site 4026) | Chapel Hill | North Carolina | 27599 | — |
| Saint Hope Foundation, Inc. ( Site 4034) | Bellaire | Texas | 77401 | — |
| North Texas Infectious Diseases Consultants, PA ( Site 4005) | Dallas | Texas | 75246 | — |
| Dr. Peter Shalit, MD ( Site 4002) | Seattle | Washington | 98104 | — |
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 79 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04233216, 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 26, 2024 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04233216 live on ClinicalTrials.gov.