drugset / Trial / NCT07862569

DOR/ISL in Pediatric Participants With HIV-1, <18 Years of Age and ≥ 35 kg

NCT07862569 ↗

Phase 2 Not yet recruiting 45 enrolled Merck Sharp & Dohme LLC
NaSingle-groupOpen-labelTreatment

Summary

This is a phase 2 study of the pharmacokinetics, safety, and efficacy of oral doravirine/islatravir (100 mg/0.25 mg) \[MK-8591A\] in pediatric participants with human immunodeficiency virus type 1 (HIV-1) infection who are virologically suppressed or treatment-naive. The Base Study will last from Day 1 to Week 96. At Week 96, participants will be given the option to participate in an optional Study Extension and receive DOR/ISL until Week 240 or until it becomes commercially accessible, whichever is first.

Timeline

Start
2026-12-23
Primary completion
2029-09-24
Completion
2033-12-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Doravirine Small molecule 100 mg Oral
Subject Islatravir Other / unclassified 0.25 mg Oral