NCT05674656 · ViiV Healthcare
Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
What this study is about
The purpose of this study is to provide data on the how the drug moves through the body (PK), safety, tolerability, effectiveness 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).
View original scientific description
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).
Interventions
DRUG
Dolutegravir/Rilpivirine FDC
Dolutegravir/Rilpivirine will be administered.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 documented plasma HIV-1 RNA result less than the lower limit of detection of the assay from a specimen collected in the 6-12 months (180-365 days) prior to Screening OR Has at least one documented plasma HIV-1 RNA result less than the lower limit of detection of the assay from a specimen collected less than 6 months (within 179 days) prior to entry and at least one documented plasma HIV-1 RNA result less t
Where
- Long Beach, California
- Washington D.C., District of Columbia
- Fort Lauderdale, Florida
- Miami, Florida
- Tampa, Florida
- Atlanta, Georgia
- Houston, Texas
Collaborators
Janssen Research & Development, LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 19, 2024 · Source of record for eligibility and locations