DOR/ISL for HIV/AIDS

Recruiting in Palo Alto (17 mi)

+96 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial aims to check if the combination of DOR and ISL is safe and well-tolerated in adults with HIV-1 who have used these drugs before. The study focuses on ensuring that the treatment does not cause harmful side effects in these patients.

Eligibility Criteria

This trial is for adults with HIV-1 who were previously treated with DOR/ISL in certain Merck Sharp & Dohme clinical studies. It's not open to those who are heavily treatment-experienced from other trials.

Inclusion Criteria

I am currently in a clinical study for DOR/ISL by MSD.

Exclusion Criteria

My HIV-1 RNA level is 200 copies/mL or higher.

Has confirmatory laboratory findings for cluster of differentiation 4+ (CD4+) T-cell counts or lymphocyte counts in the prior DOR/ISL study that meet criteria for discontinuation of DOR/ISL

Is a HTE participant receiving treatment in MK-8591A-019 or -033

Participant Groups

The study is testing the safety and how well people tolerate a combination HIV drug called Doravirine/Islatravir (DOR/ISL). There's no specific hypothesis being tested; it's more about ongoing observation of participants' reactions to the drug.

1Treatment groups

Experimental Treatment

Group I: DOR/ISLExperimental Treatment1 Intervention

Participants will receive fixed dose combination (FDC) tablet of DOR/ISL (100 mg/0.25 mg) taken once daily (QD) orally from Day 1 to Week 96. After Week 96, eligible participants may continue on DOR/ISL until week 240 or until DOR/ISL becomes commercially accessible, whichever comes first.