This is a phase 2, single-group, multi-site, open-label study of an islatravir/doravirine (ISL/DOR, MK-8591A) fixed dose combination (FDC) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric participants who are virologically suppressed (VS) on antiretroviral therapy (ART) for ≥3 months or are treatment-naive (TN). The primary purposes of the study are 1) to examine the steady-state pharmacokinetics (PK) of ISL in plasma; 2) the steady-state PK of ISL-triphosphate (ISL-TP) in peripheral blood mononuclear cells (PBMCs); and 3) to examine the safety and tolerability of ISL/DOR.
Age range
17 Years
Sex
ALL
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Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Area Under the Plasma Drug Concentration-time Curve From 0 to 24 Hours Post-dose (AUC0-24) of Islatravir (ISL)
Timeframe: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
Maximum Plasma Concentration (Cmax) of ISL
Timeframe: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
Time to Reach Maximum Plasma Concentration (Tmax) of ISL
Timeframe: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
Apparent Plasma Terminal Half-life (t½) of ISL
Timeframe: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
Apparent Total Clearance From Plasma (CL/F) of ISL
Timeframe: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
Apparent Volume of Distribution During Terminal Phase (Vz/F) of ISL
Timeframe: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
AUC0-last of ISL-triphosphate (ISL-TP) in Peripheral Blood Mononuclear Cells (PBMCs)
Timeframe: Pre-dose, and 4 and 24 hours post-dose on Day 28
Cmax of ISL-TP in PBMCs
Timeframe: Pre-dose, and 4, and 24 hours post-dose on Day 28
C24 of ISL-TP in PBMCs
Timeframe: 24 hours post-dose on Day 28
Number of Participants Experiencing ≥1 Adverse Event (AE)
Timeframe: Up to 24 weeks
Number of Participants Discontinuing From Study Treatment Due to an AE
Timeframe: Up to 24 weeks