NCT05766501

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)

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 641 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infection

Interventions

Type	Name	Description
DRUG	DOR/ISL	FDC tablet of 100 mg doravirine (DOR)/0.25 mg islatravir (ISL) taken once daily

Timeline

• Start date: 2023-03-17
• Primary completion: 2025-10-16
• Completion: 2028-09-06
• First posted: 2023-03-13
• Last updated: 2025-12-17

Locations

95 sites across 15 countries: United States, Argentina, Australia, Canada, Chile, Colombia, Israel, Japan, New Zealand, Puerto Rico, Russia, South Africa, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study