Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics

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).

Timeline

Start

2023-07-06

Primary completion

2026-06-01

Completion

2028-05-03

Drugs

Indications