Status:
COMPLETED
Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
HIV-1 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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) administer...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2022
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT03272347
Start Date
November 27 2017
End Date
March 9 2022
Last Update
March 29 2023
Active Locations (26)
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1
Pueblo Family Physicians ( Site 0119)
Phoenix, Arizona, United States, 85015
2
University California / Davis ( Site 0101)
Sacramento, California, United States, 95817
3
Whitman Walker Clinic ( Site 0108)
Washington D.C., District of Columbia, United States, 20005
4
Orlando Immunology Center (OIC) ( Site 0105)
Orlando, Florida, United States, 32803