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

Completed · Phase 2 · Has a placebo group

Conditions studied: HIV-1 Infection

In brief

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.

Key facts

Study ID

NCT03272347

Run by

Merck Sharp & Dohme LLC

People needed

123

Starts

2017-11-27

Expected to finish

2022-03-09

Last updated by the study team

2023-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• Has a documented or known virologic resistance to any approved HIV-1 reverse transcriptase inhibitor, protease inhibitor, integrase inhibitor
• Has active hepatitis C virus (HCV) coinfection defined as detectable HCV RNA or HBV co-infection defined as hepatitis B surface antigen [HBsAg]-positive
• Has a current (active) diagnosis of acute hepatitis due to any cause
• Has previously been randomized in a study and received islatravir (MK-8591), DOR, Doravirine, Tenofovir, Lamivudine, or 3TC.

Where it is running

• 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
• Clinica Arauco Salud ( Site 0200) — Santiago, RM, Chile
• Biomedica Research Group ( Site 0202) — Santiago, Chile
• Hospital Dr. Hernan Henriquez Aravena ( Site 0203) — Temuco, Chile
• Hopital Avicenne ( Site 2302) — Bobigny, France
• Hopital Saint-Andre ( Site 2307) — Bordeaux, France
• CHU Hotel Dieu ( Site 2308) — Nantes, France
• CHU de Nice Hopital Archet 1 ( Site 2303) — Nice, France
• Hopital Bichat - Claude Bernard ( Site 2309) — Paris, France
• Hopital Pitie Salpetriere ( Site 2305) — Paris, France
• Hopital Saint Louis ( Site 2306) — Paris, France
• Centre Hospitalier de Tourcoing ( Site 2301) — Tourcoing, France
• Brighton and Sussex University Hospitals NHS Trust ( Site 2105) — Brighton, East Sussex, United Kingdom
• Chelsea and Westminster Hospital ( Site 2101) — London, United Kingdom
• Royal London Hospital ( Site 2103) — London, United Kingdom
• The Royal Free London NHS Foundation Trust ( Site 2102) — London, United Kingdom

Full record on ClinicalTrials.gov

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