Open-label, Follow-up of Doravirine/Islatravir for Participants With Human Immunodeficiency Virus -1 (HIV-1) Infection (MK-8591A-033)

• Status: Recruiting
• Trial end date: 2029-02-16
• Target enrollment: 0
• Participant gender: All

Summary

The safety and tolerability of MK-8591A, a novel 2-drug fixed dose combination (FDC) of doravirine (DOR) and islatravir (ISL) will be evaluated in adult and pediatric participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: 4'-ethynyl-2-fluoro-2'-deoxyadenosine; Islatravir

Criteria

Inclusion Criteria:

• Is currently receiving DOR/ISL adult FDC tablet in a Merck-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.