CTIS2024-512215-53-00Active, not recruitingPhase 1
A Phase 3 Open-label Rollover Clinical Study of Doravirine/Islatravir (DOR/ISL) Once daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL in a Phase 2 or Phase 3 DOR/ISL Clinical Study - MK-8591A-033
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 820
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 0 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •Is currently receiving DOR 100 mg/ISL 0.75 mg adult fixed dose combination (FDC) tablet in an MSD-sponsored clinical study and has completed the last treatment visit., Is considered by the investigator to have derived clinical benefit from receiving DOR/ISL and for whom further treatment with DOR/ISL is considered clinically appropriate., Is male or female and =35 kg at the time of signing the informed consent/assent., Female is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); or is a non-pregnant WOCBP who agrees to the following during the intervention period and for at least 6 weeks after the last dose of study intervention: Not be sexually active, or if sexually active, to use an acceptable method of contraception; or is pregnant and continues to receive study intervention (where allowed by local regulations and as appropriate based on available data/local standard-of-care guidelines).
Exclusion Criteria
- •Is taking or is anticipated to require any prohibited therapies.
Investigators
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