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
ViiV Healthcare
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).
Eligibility
- Age range
- 6–12 years
- Sex
- All
- Healthy volunteers
- No
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 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. * Has a plasma HIV-1 Ribonucleic Acid (RNA) result less than 50 copies/mL at Screening * Has at least one documente…
Interventions
- DrugDolutegravir/Rilpivirine FDC
Dolutegravir/Rilpivirine will be administered.
Locations (8)
- GSK Investigational SiteLong Beach, California
- GSK Investigational SiteWashington D.C., District of Columbia
- GSK Investigational SiteFort Lauderdale, Florida
- GSK Investigational SiteMiami, Florida
- GSK Investigational SiteTampa, Florida
- GSK Investigational SiteAtlanta, Georgia