Study

Overview

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

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.

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

650

Study Start Date:

March 2023

Estimated Study Completion Date:

January 2026

Estimated Primary Completion Date:

January 2026

Eligibility

Ages Eligible for Study:

18 and older

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

CRITERIA

Inclusion Criteria:

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]).

Exclusion Criteria:

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

No Contacts or Locations in US/Canada Provided

Results

No Study Results Posted

Plain Language Summaries

Protocols

Protocol Plain Language Summary - MK-8591A-054
Protocol Plain Language Summary - MK-8591A-054

Study Detail

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)