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Antiretroviral

DOR/ISL for HIV

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 198
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will look at the safety and tolerability of a new two-drug combination of HIV medications in adults and children who have already taken them individually.

Who is the study for?
This trial is for individuals over 35 kg with HIV-1 who are benefiting from the DOR/ISL tablet in a previous MSD study. Participants must not be pregnant or breastfeeding unless local regulations allow and they agree to contraception if of childbearing potential.
What is being tested?
The trial studies MK-8591A, a combination of doravirine (100mg) and islatravir (0.75mg), assessing its safety and tolerability in those previously treated with these drugs for HIV-1.
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with HIV treatments include nausea, headache, fatigue, diarrhea, and possible liver issues. Individual experiences may vary.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 198
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 198 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Participants who discontinued due to an adverse event (AE)
Participants with serious adverse events (SAEs)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: MK-8591AExperimental Treatment1 Intervention
Fixed dose combination (FDC) tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,209 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,010 Previous Clinical Trials
5,183,267 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,885 Previous Clinical Trials
8,086,772 Total Patients Enrolled

Media Library

MK-8591A (Antiretroviral) Clinical Trial Eligibility Overview. Trial Name: NCT04776252 — Phase 3
HIV Research Study Groups: MK-8591A
HIV Clinical Trial 2023: MK-8591A Highlights & Side Effects. Trial Name: NCT04776252 — Phase 3
MK-8591A (Antiretroviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04776252 — Phase 3
~932 spots leftby Oct 2027
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