Status:
COMPLETED
Contributing Factors for Poor HIV Treatment Response in Children With TB/HIV Coinfection
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
Efavirenz (EFV)-based antiretroviral therapy (ART) remains the preferred regimen in human immunodeficiency virus (HIV)-infected children aged 3 years or older on rifampin-containing antituberculosis (...
Detailed Description
In a previous study, the study team found that first-line anti-TB therapy had minimal effect on EFV pharmacokinetics (PK) at the population level, but children with TB/HIV coinfection on anti-TB thera...
Eligibility Criteria
Inclusion
- HIV seropositive children with or without active TB
- Antiretroviral-naïve to efavirenz and meet criteria for initiation or switch to efavirenz-based ART
- Are available for follow-up until achievement of a study endpoint like completion of study at 6 months or discontinuation of ART.
Exclusion
- Unable to obtain informed signed consent parent(s) or legal guardian
- Have AIDS-related opportunistic infections other than TB
- History of acute hepatitis within 30 days of study entry
- Persistent vomiting or diarrhea at time of enrolment
- 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 :
July 31 2025
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT03800407
Start Date
January 28 2019
End Date
July 31 2025
Last Update
August 8 2025
Active Locations (1)
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1
Kwame Nkrumah University of Science and Technology
Kumasi, Ghana