Clinical Trial

Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics

Recruiting Phase 1/2
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Record status
This record was last updated September 19, 2024 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
The purpose of this study is to provide data on the pharmacokinetic (PK), safety, tolerability, efficacy and acceptability of this fixed dose combination (FDC) single tablet 2-drug regimen for virologically suppressed (HIV-1 RNA \[Ribonucleic Acid\] \< 50 \[cells per milliliter\] c/mL) children 6 to less than 12 years of age, weighing at least 25 kilogram (kg).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-01-05; most recent amendment 2024-09-13.
Status change: Not Yet Recruiting → Recruiting 2024-03-27
Trial Details
NCT Number NCT05674656
Lead Sponsor ViiV Healthcare
Collaborators: Janssen Research & Development, LLC
Conditions HIV Infections
Enrollment 20 participants
Start Date 2023-07-06
Primary Completion 2026-06-01 (estimated)
Study Completion 2028-05-03 (estimated)
Updated on ClinicalTrials.gov 2024-09-19