Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics (NCT05674656)
Phase 1/2 Study of Switching to Fixed Dose Combination Dolutegravir/Rilpivirine Among Virologically Suppressed Children, 6 to Less Than 12 Years of Age, Living With HIV-1
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: GSK Investigational Site — Long Beach, California
Age range: 6 Years to 12 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (8 Sites)
- GSK Investigational Site — Long Beach, California
- GSK Investigational Site — Washington D.C., District of Columbia
- GSK Investigational Site — Fort Lauderdale, Florida
- GSK Investigational Site — Miami, Florida
- GSK Investigational Site — Tampa, Florida
- GSK Investigational Site — Atlanta, Georgia
- GSK Investigational Site — Houston, Texas
- GSK Investigational Site — Houston, Texas
📞 Contact the Study Coordinator
Phone: (877) 379-3718
Email: GSKClinicalSupportHD@gsk.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.