Status:
COMPLETED
Adequacy of the New Pediatric Isoniazid/Rifampin/Pyrazinamide (HRZ) Tablet
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Tuberculosis
Human Immunodeficiency Virus
Eligibility:
All Genders
3-14 years
Brief Summary
Lack of quality-assured pediatric formulations of the first-line antituberculosis (anti-TB) drugs is barrier to optimized tuberculosis (TB) treatment outcome in children. In 2010 and subsequently modi...
Detailed Description
This study will evaluate the PK of the new pediatric HRZ FDC tablet in Ghanaian children with TB with and without HIV coinfection. The new HRZ FDC dispersible tablet was designed to be child-friendly ...
Eligibility Criteria
Inclusion
- Children with active TB with or without HIV coinfection. Active TB diagnosis defined by clinical criteria consistent with active TB and/or a positive AFB smear.
- Available for follow-up until completion of TB treatment and/or achievement of a study endpoint like discontinuation of therapy, and/or pharmacokinetic sampling.
Exclusion
- Children with concurrent conditions other than HIV, have acute hepatitis within 30 days of study entry, persistent vomiting, and diarrhea will be excluded from the study.
- Unable to obtain informed signed consent from parent(s) or legal guardian.
- Have AIDS-related opportunistic infections other than TB, history of or proven acute hepatitis within 30 days of study entry, persistent vomiting, or diarrhea.
- Hemoglobin \< 6 g/dl, white blood cells \< 2500/mm3, serum creatinine \> 1.5 mg/dl, aspartate transaminase (AST) and alanine transaminase (ALT) \> 2 times upper limit of normal.
Key Trial Info
Start Date :
January 28 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT03800381
Start Date
January 28 2019
End Date
August 31 2024
Last Update
November 25 2024
Active Locations (1)
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1
Kwame Nkrumah University of Science and Technology
Kumasi, Ghana