drugset / Trial / NCT07862569
DOR/ISL in Pediatric Participants With HIV-1, <18 Years of Age and ≥ 35 kg
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doravirine | Small molecule | 100 mg | Oral |
| Subject | Islatravir | Other / unclassified | 0.25 mg | Oral |