Actively Recruiting
Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
Led by ViiV Healthcare · Updated on 2024-09-19
20
Participants Needed
8
Research Sites
251 weeks
Total Duration
On this page
Sponsors
V
ViiV Healthcare
Lead Sponsor
J
Janssen Research & Development, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HIV-1 infected child aged 6 years to less than 12 years at time of consent
- Body weight of 25 kilograms or more at entry
- Confirmed HIV-1 infection
- Taken the same antiretroviral therapy regimen for at least 6 months prior to screening
- Plasma HIV-1 RNA less than 50 copies/mL at screening
- At least one documented plasma HIV-1 RNA result below detection limits in the past 6 to 12 months or two results showing viral suppression within 18 months prior to screening
- For children who have reached menarche, not pregnant based on testing at screening and baseline
- For children of reproductive potential who are sexually active, willing to use two methods of contraception during treatment and for one month after
- Not breastfeeding at baseline for children of reproductive potential
You will not qualify if you...
- Documented resistance to NNRTIs or integrase inhibitors
- HIV-1 RNA equal to or above detection limits within 12 months prior to screening
- Any antiretroviral change due to virologic failure
- History of allergy to Dolutegravir, Rilpivirine, or study drug components
- History of congestive heart failure, symptomatic arrhythmia, or significant cardiac disease
- History of unstable liver disease, cirrhosis, or biliary abnormalities (except Gilbert's syndrome or asymptomatic gallstones)
- Current pancreatitis, active WHO Stage 4 AIDS opportunistic infection, active tuberculosis or rifamycin treatment
- Need for hepatitis C therapy during study or drugs that interact with study treatment
- Use of investigational agents within 90 days or prohibited medications within 30 days before entry
- Previous antiretroviral regimen containing both Dolutegravir and Rilpivirine
- Laboratory abnormalities including severe anemia, low neutrophils, low platelets, reduced kidney function, or elevated liver enzymes
- Combination of elevated ALT and bilirubin levels
- Evidence of Hepatitis B infection
- QTc interval greater than 450 milliseconds
- Severe acute malnutrition
- Any medical or psychiatric condition making participation unsafe or complicating study
- Child is a ward of the state or government
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
GSK Investigational Site
Long Beach, California, United States, 90806
Actively Recruiting
2
GSK Investigational Site
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
3
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
Completed
4
GSK Investigational Site
Miami, Florida, United States, 33136
Actively Recruiting
5
GSK Investigational Site
Tampa, Florida, United States, 33606
Actively Recruiting
6
GSK Investigational Site
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
GSK Investigational Site
Houston, Texas, United States, 77030
Actively Recruiting
8
GSK Investigational Site
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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