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NCT04295772 · ClinicalTrials.gov registry record · Phase 2
Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are <18 Years of Age and Weigh ≥35 kg (MK-8591A-028)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT04295772 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 42 participants.
The verdict
NCT04295772, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG DOR/ISL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2020-11-26 |
| Est. Completion | 2023-01-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04295772
The ClinicalTrials.gov registry entry for NCT04295772 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which DOR/ISL is the first listed.
NCT04295772 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04295772 about?
NCT04295772 is a clinical study titled "Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are <18 Years of Age and Weigh ≥35 kg (MK-8591A-028)". 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 ther...
What is the current status of trial NCT04295772?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2020-11-26. Estimated completion is 2023-01-25.
What interventions are being tested in trial NCT04295772?
The interventions under investigation include: DOR/ISL (DRUG).
Who is sponsoring clinical trial NCT04295772?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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