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Sponsor: Merck Sharp & Dohme LLC
Conditions: HIV Infection
Interventions: DOR/ISL, BIC/FTC/TAF, Placebo to BIC/FTC/TAF, Placebo to FDC DOR/ISL
Countries: United States, Australia, Austria, Canada, Finland, France, Germany, Italy
This study will evaluate the safety and efficacy of a switch to Doravirine/Islatravir (DOR/ISL) (MK-8591A) (a fixed dose combination of doravirine 100 mg and islatravir 0.75 mg) in participants living with human immunodeficiency virus-1 (HIV-1) virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to DOR/ISL (MK-8591A) will be non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48. Participants who benefit from their assigned intervention (as determined by investigator) will be able to continue treatment through a 24-week study extension.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Is HIV-1 positive with plasma Human Immunodeficiency Virus 1 (HIV-1) RNA \<50 copies/mL at screening. * Has been receiving bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) therapy with documented viral suppression (HIV-1 RNA \<50 copies/mL) for ≥3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen. * Females are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) within 24 hours before the first dose of study intervention; if a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Exclusion Criteria: * Has HIV-2 infection. * Has an active diagnosis of hepatitis due to any cause, including active Hepatitis B Virus (HBV) co-infection. * Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma. * Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies. * Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period. * Has a documented or known virologic resistance to doravirine (DOR). * expects to conceive or donate eggs at any time during the study.
- Phoenix, Arizona, United States
- Beverly Hills, California, United States
- Los Angeles, California, United States
- Los Angeles, California, United States
- Palm Springs, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Washington D.C., District of Columbia, United States
- Fort Lauderdale, Florida, United States
- Ft. Pierce, Florida, United States
- Miami, Florida, United States
- Miami Beach, Florida, United States
- Orlando, Florida, United States
- West Palm Beach, Florida, United States
- Augusta, Georgia, United States
- Decatur, Georgia, United States
- Macon, Georgia, United States
- Savannah, Georgia, United States
- Minneapolis, Minnesota, United States
- Kansas City, Missouri, United States
- Hillsborough, New Jersey, United States
- New York, New York, United States
- The Bronx, New York, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Longview, Texas, United States
- Seattle, Washington, United States
- Spokane, Washington, United States
- Darlinghurst, New South Wales, Australia
- Darlinghurst, New South Wales, Australia
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