Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05674656 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Primary completion date: Jul 22, 2025 to Jun 1, 2026 Completion date: Jun 8, 2027 to May 3, 2028 · Site details revised at 1 of 8 sitesv5 Show 2 more changesShow less
    • Completion date: Jun 8, 2027 to May 3, 2028
    • Site details revised at 1 of 8 sites
  2. Site details revised at 4 of 8 sitesv4
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 8 · Primary completion date: Feb 26, 2025 to Jul 22, 2025 · Completion date: Jan 13, 2027 to Jun 8, 2027 · 1 morev3 Show 4 more changesShow less
    • Study sites: 0 to 8
    • Primary completion date: Feb 26, 2025 to Jul 22, 2025
    • Completion date: Jan 13, 2027 to Jun 8, 2027
    • Start date changed from estimate of Jun 1, 2023 to Jul 6, 2023
  4. Start date: Feb 10, 2023 to Jun 1, 2023v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05674656
Lead Sponsor ViiV Healthcare
Collaborators: Janssen Research & Development, LLC
Conditions HIV Infections
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov