Dolutegravir + Rilpivirine for HIV
What You Need to Know Before You Apply
What is the purpose of 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).
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications, but it requires that participants have been on the same antiretroviral therapy (ART) regimen for the 6 months before joining. It's best to discuss your current medications with the trial team.
Is Dolutegravir + Rilpivirine safe for humans?
Dolutegravir + Rilpivirine is generally well tolerated in humans, with common side effects including headache and diarrhea. It has shown favorable effects on kidney and bone health compared to other treatments and is considered safe for people who are already stable on their current HIV treatment.12345
What makes the drug Dolutegravir/Rilpivirine unique for treating HIV?
Dolutegravir/Rilpivirine is unique because it is the first two-drug single-tablet regimen approved for HIV-1 treatment, offering a simpler alternative to the standard triple-drug therapies. It is taken once daily and is effective for patients who are already virologically suppressed, with benefits like fewer drug interactions and positive effects on kidney and bone health.23456
What data supports the effectiveness of the drug Dolutegravir/Rilpivirine for HIV?
Research shows that switching to the drug Dolutegravir/Rilpivirine helps maintain control of the HIV virus in patients who are already successfully managing their condition with other treatments. It is generally well tolerated and may have benefits for kidney and bone health compared to other treatments.23467
Who Is on the Research Team?
GSK Clinical Trials
Principal Investigator
ViiV Healthcare
Are You a Good Fit for This Trial?
This trial is for HIV-1 infected children aged 6 to less than 12 years, weighing at least 25 kg. They must have been on the same antiretroviral therapy for the past six months and have a viral load of less than 50 copies/mL. Participants should not be pregnant or breastfeeding and if of reproductive potential, agree to use two contraception methods.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the fixed dose combination of Dolutegravir/Rilpivirine
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dolutegravir/Rilpivirine FDC
Dolutegravir/Rilpivirine FDC is already approved in United States, European Union for the following indications:
- HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known mutations associated with resistance to the individual components of Juluca
- HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known mutations associated with resistance to the individual components of Dolutegravir/Rilpivirine
Find a Clinic Near You
Who Is Running the Clinical Trial?
ViiV Healthcare
Lead Sponsor
Dr. Harmony Garges
ViiV Healthcare
Chief Medical Officer
MD
Deborah Waterhouse
ViiV Healthcare
Chief Executive Officer since 2017
Bachelor's degree in Business Administration
Janssen Research & Development, LLC
Industry Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University