Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)
Public ClinicalTrials.gov record NCT03272347. 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 2B, Randomized, Double-Blind, Active-Comparator-Controlled, Dose-Ranging Clinical Trial to Evaluate the Safety, Tolerability, Antiretroviral Activity, and Pharmacokinetics of MK-8591 Given in Combination With Doravirine (DOR) and Lamivudine (3TC) in HIV-1-Infected Treatment-Naïve Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the safety, tolerability, antiretroviral activity, and pharmacokinetics of 3 doses of islatravir (MK-8591) in combination with doravirine (DOR) and lamivudine (3TC) administered to antiretroviral treatment-naïve adult participants with human immunodeficiency virus type 1 (HIV-1) infection.
Study identification
- NCT ID
- NCT03272347
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 123 participants
Conditions and interventions
Conditions
Interventions
- Islatravir Drug
- Placebo to Islatravir Drug
- Doravirine Drug
- Placebo to Doravirine Drug
- Lamivudine Drug
- Placebo to Lamivudine Drug
- Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate Drug
- Placebo to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate Drug
- Doravirine/Islatravir Drug
Drug
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
- Nov 26, 2017
- Primary completion
- Mar 7, 2021
- Completion
- Mar 8, 2022
- Last update posted
- Mar 28, 2023
2017 – 2022
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pueblo Family Physicians ( Site 0119) | Phoenix | Arizona | 85015 | — |
| University California / Davis ( Site 0101) | Sacramento | California | 95817 | — |
| Whitman Walker Clinic ( Site 0108) | Washington D.C. | District of Columbia | 20005 | — |
| Orlando Immunology Center (OIC) ( Site 0105) | Orlando | Florida | 32803 | — |
| Northstar Medical Center ( Site 0102) | Chicago | Illinois | 60657 | — |
| Kansas City CARE Clinic ( Site 0106) | Kansas City | Missouri | 64111 | — |
| Saint Hope Foundation, Inc. ( Site 0116) | Bellaire | Texas | 77401 | — |
| North Texas Infectious Diseases Consultants, PA ( Site 0103) | Dallas | Texas | 75246 | — |
| Tarrant County Infectious Disease Associates ( Site 0112) | Fort Worth | Texas | 76104 | — |
| The Crofoot Research Center, Inc. ( Site 0118) | 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 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03272347, 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 Mar 28, 2023 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03272347 live on ClinicalTrials.gov.