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RECRUITING
NCT05674656
PHASE1/PHASE2

Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics

Sponsor: ViiV Healthcare

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-07-06

Completion Date

2028-05-03

Last Updated

2024-09-19

Healthy Volunteers

No

Conditions

Interventions

DRUG

Dolutegravir/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