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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.