This study is in progress, not accepting new patients

A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)

Eligibility: for people ages 18 years and up (full criteria)
Location: at UC Davis
Dates: study started March 2023
study ends around September 2028

Description

Summary

The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.

Official Title

A Phase 3 Open-label Clinical Study of Doravirine/Islatravir (DOR/ISL [100 mg/0.25 mg]) Once Daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL (100 mg/0.75 mg) QD in a Phase 3 Clinical Study

Keywords

HIV Infection, Infections, Communicable Diseases, Islatravir, DOR/ISL

Eligibility

You can join if…

Open to people ages 18 years and up

Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp & Dohme (MSD)-sponsored clinical studies (MK-8591A-017, -018, -020, and -033 [except for heavily treatment-experienced (HTE) participants]).

You CAN'T join if...

Has confirmed HIV-1 RNA ≥200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-017 /-018 /-020, or at screening for participants entering from DOR/ISL (100 mg/0.75 mg) MK-8591A-033.
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.

Locations

University of California Davis Health-Internal Medicine: Infectious Diseases ( Site 3137)
Sacramento California 95817 United States
Pacific Oaks Medical Group ( Site 3123)
Beverly Hills California 90211 United States
Mills Clinical Research ( Site 3114)
Los Angeles California 90069 United States
Ruane Clinical Research Group, Inc ( Site 3126)
Los Angeles California 90036 United States
Kaiser Permanente ( Site 3124)
Los Angeles California 90027 United States

Details

Status: in progress, not accepting new patients
Start Date: March 2023
Completion Date: September 2028 (estimated)
Sponsor: Merck Sharp & Dohme LLC
Links: Merck Clinical Trials Information Plain Language Summary
ID: NCT05766501
Phase: Phase 3 research study
Study Type: Interventional
Participants: Expecting 650 study participants
Last Updated: November 2024