RecruitingPhase 1Phase 2NCT05674656

Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics

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


Sponsor

ViiV Healthcare

Enrollment

20 participants

Start Date

Jul 6, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 6 YearsMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how two HIV medications — dolutegravir and rilpivirine (taken together as a single pill) — behave in the bodies of children aged 6 to under 12 years. Researchers want to understand safety, tolerability, and how the drugs are processed in younger patients. **You may be eligible if...** - Your child is between 6 and under 12 years old and has confirmed HIV-1 infection - Your child weighs at least 25 kg (about 55 lbs) - Your child has been on the same HIV treatment regimen for at least the past 6 months - Your child's HIV viral load is undetectable (under 50 copies/mL) at screening **You may NOT be eligible if...** - Your child has ever had resistance to the class of HIV drugs called NNRTIs or integrase inhibitors - Your child has had a change in HIV treatment due to the virus not being controlled - Your child has serious heart, liver, or kidney problems - Your child has active hepatitis B infection or an untreated hepatitis C infection - Your child is pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDolutegravir/Rilpivirine FDC

Dolutegravir/Rilpivirine will be administered.


Locations(8)

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Washington D.C., District of Columbia, United States

GSK Investigational Site

Fort Lauderdale, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Tampa, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05674656


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