DOR/ISL in Pediatric Participants With HIV-1, <18 Years of Age and ≥ 35 kg
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorMerck Sharp & Dohme LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
DOR/ISL
DrugDOR/ISL 100 mg/0.25 mg tablet taken by mouth qd
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: DOR/ISLExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Area under the plasma conentration-time curve from dosing to 24 hours postdose (AUC0-24) of ISL
The plasma AUC0-24 will be assessed.
Time frame
At designated timepoints on Day 282
Maximum plasma concentration (Cmax) of ISL
The plasma Cmax will be assessed.
Time frame
At designated timepoints on Day 283
Time to maximum plasma concentration (Tmax) of ISL
The plasma Tmax will be assessed.
Time frame
At designated timepoints on Day 284
Apparent plasma terminal half-life (t½) of ISL
The plasma t½ will be assessed.
Time frame
At designated timepoints on Day 28Secondary outcomes
1
Percentage of participants with ≥1 AE through Week 96
The percentage of participants with AE(s) will be assessed.
Time frame
Up to 96 weeks2
Percentage of participants discontinuing from study therapy due to AE(s) through Week 96
The percentage of participants with AE(s) will be assessed.
Time frame
Up to 96 weeks3
Percentage of virologically-suppressed (VS) participants with Human Immunodeficiency Virus Type 1 (HIV-1) ribonucleic acid (RNA) ≥50 copies/mL
The percentage of VS participants with HIV-1 RNA ≥50 copies/mL will be assessed.
Time frame
Weeks 24, 48, and 964
Percentage of VS participants with HIV-1 RNA <50 copies/mL
The percentage of VS participants with HIV-1 RNA \<50 copies/mL will be assessed.
Time frame
Weeks 24, 48, and 96Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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