Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics

Recruiting Phase 1 Phase 2 Interventional Study
HIV Infections
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
6 – 12
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
ViiV Healthcare · Industry
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Human immuno virus Type-1 (HIV-1) infected child 6 years to less than 12 years of age at the time of signing the informed consent form . * Body weight greater than or equal to 25 kilogram (kg) at entry. * Confirmed HIV-1-infection * Participant has taken the same Antiretrovira…
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