Status:
COMPLETED
Pharmacokinetics of Intracellular TFV-DP and FTC-TP in HIV-infected Adolescents
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Human Immunodeficiency Virus (HIV)
Tuberculosis
Eligibility:
All Genders
10-19 years
Brief Summary
Tenofovir (TFV) disoproxil fumarate (TDF) plus emtricitabine (FTC) or lamivudine (3TC) is the preferred nucleoside backbone of first-line antiretroviral therapy (ART) for adolescents in sub-Saharan Af...
Detailed Description
This study will evaluate the intracellular PK of TFV-DP and FTC-TP in Ghanaian HIV-infected adolescents with and without TB coinfection. As the clinical effects of TDF and FTC are related to the intra...
Eligibility Criteria
Inclusion
- HIV-infected adolescents aged 10 to 19 years old who are stable on antiretroviral regimen containing TDF/FTC (300/200 mg daily) for at least 8 weeks.
Exclusion
- Unable to obtain informed signed consent from parent(s) or legal guardian.
- Pregnant or breast feeding.
- Require therapy for other opportunistic infections other than tuberculosis (TB).
Key Trial Info
Start Date :
January 28 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03800394
Start Date
January 28 2019
End Date
July 31 2024
Last Update
August 7 2024
Active Locations (1)
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1
Kwame Nkrumah University of Science and Technology
Kumasi, Ghana