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Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
NCT05674656 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 82 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05674656 reports 8 study locations spanning 5 distinct geographic areas — top geographies include Florida, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05674656?
The interventions under investigation include: Dolutegravir/Rilpivirine FDC (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05674656?
This trial is sponsored by ViiV Healthcare, which has 82 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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