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

Brief 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.

Brief Title

Categories

Blood Disorders

COVID-19

Hepatitis

HIV/AIDS

Immune System

Infectious Disease

Pediatrics / Children's Health

Completion Date

2033-12-23

Completion Date Type

Estimated

Conditions

HIV-1

HIV INFECTION

Eligibility Criteria

Inclusion Criteria:

* Pediatric participant with HIV-1 \<18 years of age
* Body weight ≥35 kg
* Is TN (HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL) or VS (HIV-1 positive at screening with plasma HIV-1 RNA \<50 copies/mL AND has received stable, continuous 2- or 3-drug antiretroviral therapy (ART) for ≥3 months prior to providing informed consent)

Exclusion Criteria:

* HIV-2 infection
* Hypsensitivity/contraindication to any components of study medication or as determined by the investigator
* Has an active diagnosis of hepatitis due to any cause
* history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
* Has a history or current evidence of any condition (including active tuberculosis infection, COVID-19, or other infections), therapy, laboratory abnormality, or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study
* Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies

Inclusion Criteria

Inclusion Criteria:

* Pediatric participant with HIV-1 \<18 years of age
* Body weight ≥35 kg
* Is TN (HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL) or VS (HIV-1 positive at screening with plasma HIV-1 RNA \<50 copies/mL AND has received stable, continuous 2- or 3-drug antiretroviral therapy (ART) for ≥3 months prior to providing informed consent)

Gender

All

Gender Based

false

Healthy Volunteers

No

Last Update Post Date

Wed, 10/07/2026 - 12:00

Last Update Post Date Type

Actual

Last Update Submit Date

Fri, 10/02/2026 - 12:00

Maximum Age

18 Years

NCT Id

NCT07862569

Org Class

Industry

Org Full Name

Merck Sharp & Dohme LLC

Org Study Id

8591A-063

Overall Status

Not yet recruiting

Phases

Phase 2

Primary Completion Date

Mon, 09/24/2029 - 12:00

Primary Completion Date Type

Estimated

Official Title

A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Oral Doravirine/Islatravir (100 mg/0.25 mg) in Pediatric Participants With HIV-1 Infection Who Are Virologically Suppressed or Treatment-Naïve, Are Less Than 18 Years of Age, and Weigh Greater Than or Equal to 35 kg

Primary Outcomes

Outcome Description

The plasma AUC0-24 will be assessed.

Outcome Measure

Area under the plasma conentration-time curve from dosing to 24 hours postdose (AUC0-24) of ISL

Outcome Time Frame