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NCT05674656 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
A Phase 1 study of HIV Infections, sponsored by ViiV Healthcare.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 8
- Study locations
NCT05674656 is a Phase 1 study of HIV Infections that is actively recruiting participants, run by ViiV Healthcare. The registered enrollment target is 20 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower). The trial reports 8 study locations across 5 states.
The verdict
NCT05674656, a Phase 1 study of HIV Infections, is actively recruiting participants, sponsored by ViiV Healthcare.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 8
- Study locations
Study 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).
Conditions Studied
Interventions
- DRUG Dolutegravir/Rilpivirine FDC
Study Locations (8)
Florida
- GSK Investigational Site - Fort Lauderdale
- GSK Investigational Site - Miami
- GSK Investigational Site - Tampa
Texas
- GSK Investigational Site - Houston
- GSK Investigational Site - Houston
California
- GSK Investigational Site - Long Beach
District of Columbia
- GSK Investigational Site - Washington D.C.
Georgia
- GSK Investigational Site - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-07-06 |
| Est. Completion | 2028-05-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05674656
The ClinicalTrials.gov registry entry for NCT05674656 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower). The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Dolutegravir/Rilpivirine FDC is the first listed.
NCT05674656 reports 8 study locations spanning 5 distinct geographic areas - top geographies include Florida, Texas, California.
Frequently Asked Questions
What is clinical trial NCT05674656 about?
NCT05674656 is a clinical study titled "Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics". 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...
What is the current status of trial NCT05674656?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-07-06. Estimated completion is 2028-05-03.
What conditions does trial NCT05674656 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT05674656?
The interventions under investigation include: Dolutegravir/Rilpivirine FDC (DRUG).
Who is sponsoring clinical trial NCT05674656?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05674656 being conducted?
This trial has 8 study locations across California, District of Columbia, Florida, Georgia, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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