Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
ConditionHIV Infections
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-12
SponsorViiV Healthcare
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).
Eligibility criteria
Qualifiers
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 Antiretroviral therapy (ART) regimen in the 6 months (180 days) prior to Screening, as determined by the site investigator based on participant/parent/guardian report and available medical records.
Disqualifiers
Documented resistance (ever) to Non-nucleoside reverse transcriptase inhibitors (NNRTIs) or integrase inhibitors
Documented HIV-1 RNA result greater than or equal to the lower limit of detection of the assay based on a specimen collected in the 12 months (365 days) prior to Screening
Any change (ever) of any Antiretroviral (ARV) agent due to virologic failure, as determined by the site investigator based on participant/parent/guardian report and available medical records
Has a history (ever) of allergy to DTG, RPV, or any other component of JULUCA as determined by the site investigator based on participant/parent/guardian report and available medical records.
Trial design
Treatments tested in this trial
- Dolutegravir/Rilpivirine FDC
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
ViiV Healthcare
Lead sponsor
Janssen Research & Development, LLC
Collaborator
Source ClinicalTrials.gov