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Pharmacokinetics of Intracellular TFV-DP and FTC-TP in HIV-infected Adolescents

NCT03800394 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 52

Last updated 2024-08-07

No results posted yet for this study

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 Africa. In addition, TDF/FTC is recommended for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection in adolescents at substantial risk of acquisition of HIV infection, as well as for hepatitis B virus (HBV) treatment in those with HBV/HIV coinfection. The efficacy TDF and FTC are dependent on intracellular concentrations of the active phosphate anabolites, called TFV diphosphate (TFV-DP) and FTC triphosphate (FTC-TP). However, the intracellular pharmacokinetics of TFV-DP and FTC-TP to examine the adequacy of current dosages in African adolescents has not been previously studied. Thus, examining the pharmacokinetics (PK) of these widely used antiretrovirals in African adolescents is important as ART outcomes remain poor and the recommended dosages of these drugs for children and adolescent were extrapolated from drug approval clinical trials in adult in the United States and Europe.

Conditions

  • Human Immunodeficiency Virus (HIV)
  • Tuberculosis
  • Coinfection

Interventions

OTHER

Observational PK study

Effect of antituberculosis treatment, age and genetic factors on intracellular TFV-DP and FTC-TP concentrations

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Awewura Kwara, MD · University of Florida

Eligibility

Min Age
10 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-28
Primary Completion
2024-05-31
Completion
2024-07-31

Countries

  • Ghana

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03800394 on ClinicalTrials.gov