Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
Status:
Not yet recruiting
Trial end date:
2027-01-13
Target enrollment:
Participant gender:
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).
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
ViiV Healthcare
Collaborator:
Janssen Research & Development, LLC
Treatments:
Dolutegravir Dolutegravir, rilpivirine drug combination Rilpivirine