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

Purpose

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.

Condition

  • HIV-1 Infection

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MK-8591A
Fixed dose combination (FDC) tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for 96 weeks.
  • Drug: MK-8591A
    FDC tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for 96 weeks

Recruiting Locations

Georgetown University Medical Center-Clinical Trials Unit Division of Infectious Diseases ( Site 002
Washington, District of Columbia 20007
Contact:
Study Coordinator
202-444-0152

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@merck.com