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Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)

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

NCT03272347•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has HIV-1 infection
•Is naïve to anti-retroviral therapy (ART).
•Is clinically stable, with no signs or symptoms of acute infection, at the time of entry into the study
•Female is not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP); but if WOCBP agrees to follow the contraceptive guidance
•All participants, male and female, agree to use barrier methods of contraception when engaged in any sexual activity during treatment and for 6 weeks following treatment.

Exclusion Criteria

•Is a user of recreational or illicit drugs or has had a history of drug or alcohol abuse or dependence that may interfere with trial participation
•Has significant hypersensitivity or other contraindication to any of the components of the study drugs
•Has a history of malignancy ≤5 years prior
•Female expects to donate eggs at any time during the study
•Is breastfeeding or expecting to conceive
•A WOCBP who has a positive urine pregnancy test on Day 1 before the first dose of study treatment
•Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1
•Has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study
•Requires any of the following prohibited medications: Carbamazepine, Phenobarbital, Phenytoin, Rifabutin, Rifampin, Herbal remedies, St. John's Wort, Modafinil, Bosentan, Nafcillin, Pentostatin
•Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing informed consent to participate in this current trial
+4 more criteria

Locations (26)

Pueblo Family Physicians ( Site 0119)

Phoenix, Arizona, United States

University California / Davis ( Site 0101)

Sacramento, California, United States

Whitman Walker Clinic ( Site 0108)

Washington D.C., District of Columbia, United States

Orlando Immunology Center (OIC) ( Site 0105)

Orlando, Florida, United States

Northstar Medical Center ( Site 0102)

Chicago, Illinois, United States

Kansas City CARE Clinic ( Site 0106)

Kansas City, Missouri, United States

Saint Hope Foundation, Inc. ( Site 0116)

Bellaire, Texas, United States

North Texas Infectious Diseases Consultants, PA ( Site 0103)

Dallas, Texas, United States

Tarrant County Infectious Disease Associates ( Site 0112)

Fort Worth, Texas, United States

The Crofoot Research Center, Inc. ( Site 0118)

Houston, Texas, United States

Key Dates

Start Date

November 27, 2017

Primary Completion Date

March 8, 2021

Completion Date

March 9, 2022

Last Updated

March 29, 2023

Enrollment

123

ACTUAL participants

Conditions

HIV-1 Infection

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

Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI

NCT06602622

HIVHIV Associate Weight Loss+4 more

View study

COMPLETEDPHASE4

Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine

NCT06185452

HIV-1 Infection

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 29, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)

Inclusion Criteria

Exclusion Criteria

Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI

Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine

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