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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Dolutegravir/Rilpivirine will be administered.
GSK Investigational Site
Long Beach, California, United States
RECRUITINGGSK Investigational Site
Washington D.C., District of Columbia, United States
RECRUITINGGSK Investigational Site
Fort Lauderdale, Florida, United States
Area under the curve (AUC0-24h) of DTG
Time frame: Up to Week 24
Area under the curve (AUC0-24h) of RPV
Time frame: Up to Week 24
Number of Participants with Adverse Events (AEs) at Week 24
Time frame: At Week 24
Number of Participants with Grade 3 or higher AEs at Week 24
Time frame: At Week 24
Number of Participants with Grade 3 or higher AEs assessed as related to study drug at Week 24
Time frame: At Week 24
Number of Participants with Fatal AEs assessed as related to study drug at Week 24
Time frame: At Week 24
Number of Participants with Serious Adverse Events (SAEs) assessed as related to study drug at Week 24
Time frame: At Week 24
Number of Participants with AEs assessed as related to study drug that led to permanent discontinuation of study drug at Week 24
Time frame: At Week 24
Proportion of Participants with HIV-1 RNA less than 50 copies per milliliter (c/mL)
Time frame: At Week 24 and 48
Cluster of differentiation 4 (CD4+) Cell Count
Time frame: At Week 24 and 48
Percentage of CD4+ Cell Count
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GSK Investigational Site
Miami, Florida, United States
RECRUITINGGSK Investigational Site
Tampa, Florida, United States
RECRUITINGGSK Investigational Site
Atlanta, Georgia, United States
RECRUITINGGSK Investigational Site
Houston, Texas, United States
RECRUITINGGSK Investigational Site
Houston, Texas, United States
RECRUITINGTime frame: At Week 24 and 48
Number of Participants with Adverse Events (AEs) at Week 48
Time frame: At Week 48
Number of Participants with Grade 3 or higher AEs at Week 48
Time frame: At Week 48
Number of Participants with Grade 3 or higher AEs assessed as related to study drug at Week 48
Time frame: At Week 48
Number of Participants with Fatal AEs assessed as related to study drug at Week 48
Time frame: At Week 48
Number of Participants with Serious Adverse Events (SAEs) assessed as related to study drug at Week 48
Time frame: At Week 48
Number of Participants with AEs assessed as related to study drug that led to permanent discontinuation of study drug at Week 48
Time frame: At Week 48
Minimum drug concentration (Cmin) of DTG
Time frame: Up to Week 24
Cmin of RPV
Time frame: Up to Week 24
Cmin of DTG at Week 4 Visit
Time frame: Pre-dose, 1, 2, 4, 5, 6, 10 and 24 hours (h) post-dose at Week 4
Cmin of RPV at Week 4 Visit
Time frame: Pre-dose, 1, 2, 4, 5, 6, 10 and 24 hours (h) post-dose at Week 4
Concentration of HIV-1 RNA
Time frame: Baseline (Day 1), Week 4, 8, 12, 16, 20, 24, 36 and 48
Number of Participants with HIV-1 Genotype at the time of Virologic failure (HIV-1 RNA greater than or equal to 200 copies/mL)
Time frame: Baseline (Day 1) and up to Week 48
Number of Participants with HIV-1 Phenotype at the time of Virologic failure (HIV-1 RNA greater than or equal to 200 copies/mL)
Time frame: Up to Week 48
Number of Participants with HIV-1 genotypes at Baseline, Week 24 and 48
Time frame: Baseline (Day 1), Week 24 and 48
Number of Participants with Acceptability to JULUCA
Time frame: At Week 4, 24 and 48
Number of Participants with Adherence to JULUCA
Time frame: At Week 4, 24 and 48