Status:
ACTIVE_NOT_RECRUITING
Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
HIV-1 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine (100mg) and islatravir (0.75mg) \[DOR/ISL 100 mg/0.75 mg) will be evaluated in participants with Human Immu...
Detailed Description
As of Amendment 12, participants will have the option to continue receiving DOR/ISL (100 mg/0.75 mg) until treatment alternatives are identified, or up to Week 288 given that participants are still de...
Eligibility Criteria
Inclusion
- Is currently receiving DOR 100 mg/ISL 0.75 mg adult 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.
- 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
- Is taking or is anticipated to require any prohibited therapies.
Key Trial Info
Start Date :
September 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 29 2029
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04776252
Start Date
September 15 2021
End Date
May 29 2029
Last Update
December 23 2025
Active Locations (93)
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1
Pueblo Family Physicians ( Site 0010)
Phoenix, Arizona, United States, 85015
2
One Community Health ( Site 0045)
Sacramento, California, United States, 95811
3
Whitman-Walker Institute ( Site 0039)
Washington D.C., District of Columbia, United States, 20005
4
Georgetown University Medical Center-Clinical Trials Unit Division of Infectious Diseases ( Site 002
Washington D.C., District of Columbia, United States, 20007