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New treatment option for Pediatric HIV Infection
Official title Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin
ClinicalTrials.gov ID: NCT05069688
What this study is testing
What is rifampicin?
rifampicin is an investigational medicine, given as an once-daily, being studied as a potential treatment for pediatric hiv infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Tuberculosis (TB) is the leading cause of death among children with HIV, yet insufficient data are available on the pharmacokinetics of newer HIV/TB cotreatment strategies in children. Current WHO-recommended rifampicin dosages result in low concentrations in most children, and high-dose rifampicin may improve outcomes and shorten treatment duration.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 5
You may be able to join if
- ART-naïve or ART-experienced HIV-infected children between 4 weeks and \<6 years of age
- Active TB diagnosis
- Weight of at least 3 kilograms
- Consent of the parent or legal guardian
You likely can't join if
- Baseline labs with evidence of ≥grade 3 abnormalities: ALT, total bilirubin, absolute neutrophil count (ANC), platelets, or creatinine
- Suspected TB meningitis or presenting with acute respiratory distress or decompensation
- Receipt of a medication that has drug-drug interactions with dolutegravir or rifampicin
The study team makes the final eligibility decision.
Where it's taking place
- Ibadan, Oyo State, Nigeria
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 weeks to 5 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ibadan, Oyo State, Nigeria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.