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Clinical trial

Mind the Gaps: Pharmacokinetic Research to Advance Pediatric HIV/TB Cotreatment and TB Prevention

ID
Name
2021P002401
Description
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. Yet the impact of high-dose rifampicin on dolutegravir exposures has not been examined in children. This study aims to evaluate the safety and pharmacokinetics of dolutegravir twice daily among HIV/TB coinfected children receiving standard-dose and high-dose rifampicin.
Trial arms
Trial start
2023-07-07
Estimated PCD
2025-03-31
Trial end
2025-03-31
Status
Recruiting
Phase
Early phase I
Treatment
rifampicin
Patients will receive standard TB and HIV treatment, however, for two weeks (study weeks 20-21) the dose of rifampicin will be increased from standard-dose to high-dose to assess pharmacokinetics and safety
Arms:
Dolutegravir PK during standard and high-dose rifampicin
Size
20
Primary endpoint
Dolutegravir AUC during standard-dose rifampicin
week 20
Dolutegravir AUC during high-dose rifampicin
week 22
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective single-arm, open-label, pharmacokinetic and safety study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2023-07-28

1 organization

1 product

2 indications

Organization
Brigham and Women's Hospital
Product
rifampicin
Indication
Pediatric HIV infection
Indication
Tuberculosis