Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)

Completed · Phase 3 · Has a placebo group

Conditions studied: HIV-1 Infection

In brief

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).

Key facts

Study ID

NCT04233216

Run by

Merck Sharp & Dohme LLC

People needed

35

Starts

2020-03-18

Expected to finish

2023-11-01

Last updated by the study team

2024-12-27

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is HIV-1 positive.
• Has been receiving the same baseline ART for ≥3 months prior to signing the Informed Consent Form/Assent Form.
• Weighs ≥35 kg.
• Has at least triple-class resistance (must include nucleoside reverse transcriptase inhibitor [NRTI], non-nucleoside reverse transcriptase inhibitor [NNRTI], and resistance to either protease inhibitor (PI) or integrase strand transfer inhibitor (InSTI), based on central laboratory-based resistance or proviral DNA resistance testing at the Screening Visit, or historical resistance testing within 12 months of screening.
• Has ≤2 fully active antiretroviral drugs remaining among all antiretroviral classes that can be effectively combined to form a viable regimen based on resistance, tolerability, safety, drug access, or acceptability to participant.
• If female, is not pregnant or breastfeeding, and is: 1) not a woman of childbearing potential (WOCBP); 2) a WOCBP and uses an acceptable method of contraception/is abstinent; or 3) a WOCBP and has a negative pregnancy test within 24 hours of the first dose of study medication.

You may not qualify if…

• Has HIV type 2 (HIV-2) infection.
• Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator.
• Has hepatitis B virus (HBV) co-infection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA] positive) and is not currently being treated for HBV.
• Has a history or current evidence of any condition, therapy (including active TB co-infection), laboratory abnormality or other circumstance (including drug or alcohol abuse or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with study participation for the full study duration.
• Is taking or is anticipated to require any of the prohibited therapies from the Screening Visit and throughout the study treatment period.
• Is taking DOR as part of his/her current failing antiretroviral regimen.
• Is taking efavirenz (EFV), etravirine, or nevirapine.
• Is currently participating in or has participated in an interventional clinical study with an investigational compound or device from the Screening Visit through the study treatment period.
• Is female and is expecting to conceive or donate eggs at any time during the study.

Where it is running

• Men's Health Foundation ( Site 4018) — Los Angeles, California, United States
• Palmtree Clinical Research, Inc. ( Site 4016) — Palm Springs, California, United States
• Yale School of Medicine ( Site 4007) — New Haven, Connecticut, United States
• Georgetown University Hospital ( Site 4015) — Washington D.C., District of Columbia, United States
• The Kinder Medical Group ( Site 4014) — Miami, Florida, United States
• Orlando Immunology Center ( Site 4012) — Orlando, Florida, United States
• Triple O Research Institute, P.A. ( Site 4020) — West Palm Beach, Florida, United States
• Chatham County Health Department ( Site 4029) — Savannah, Georgia, United States
• Howard Brown Health Center ( Site 4006) — Chicago, Illinois, United States
• Northstar Healthcare ( Site 4004) — Chicago, Illinois, United States
• University of Maryland ( Site 4023) — Baltimore, Maryland, United States
• The University of Mississippi Medical Center ( Site 4036) — Jackson, Mississippi, United States
• Saint Michael's Medical Center-Research - Infectious Disease ( Site 4035) — Newark, New Jersey, United States
• Icahn School of Medicine at Mount Sinai ( Site 4000) — New York, New York, United States
• University of North Carolina at Chapel Hill ( Site 4026) — Chapel Hill, North Carolina, United States
• Saint Hope Foundation, Inc. ( Site 4034) — Bellaire, Texas, United States
• North Texas Infectious Diseases Consultants, PA ( Site 4005) — Dallas, Texas, United States
• Dr. Peter Shalit, MD ( Site 4002) — Seattle, Washington, United States
• Holdsworth House Medical Practice ( Site 5300) — Sydney, New South Wales, Australia
• St Vincent's Hospital ( Site 5309) — Sydney, New South Wales, Australia
• Holdsworth House Medical Practice - Brisbane ( Site 5312) — Brisbane, Queensland, Australia
• Monash Health-Monash Medical Centre ( Site 5313) — Clayton, Victoria, Australia
• The Alfred Hospital ( Site 5304) — Melbourne, Victoria, Australia
• Vancouver ID Research and Care Centre Society ( Site 4100) — Vancouver, British Columbia, Canada
• University of Alabama at Birmingham 1917 Research Clinic ( Site 4031) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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