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GS1269: Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected Children and Adolescents Virologically Suppressed on a 2-NRTI-Containing Regimen

About this study

This study enrolled patients who have HIV and are currently receiving treatment for HIV. This research study involves the use of an experimental drug named Emtricitabine/Tenofovir Alafenamide (F/TAF). This drug is used for the treatment of HIV-1 infections in children and adolescents. This drug is experimental because it has not been approved by any regulatory authority. The purpose of this study is to determine the pharmacokinetics (PK) of the study drug in your body, the safety and tolerability of the study drug, and the antiviral activity of the study drug in children when combined with a third antiretroviral (ARV) medication. PK testing looks at the level of the study drug in the blood to see how well the body takes the drug into the blood, delivers drug through the blood, breaks down or processes the drug, and removes it.

Objectives

  • To evaluate the pharmacokinetics (PK) of Tenofovir Alafenamide (TAF) and confirm the TAF dose in HIV-1 infected children and adolescents virologically suppressed on a Tenofovir Disoproxil Fumarate (TDF) - containing regimen
  • To evaluate the safety and tolerability of Emtricitabine/Tenofovir Alafenamide (F/TAF) through week twenty-four (24)
  • To evaluate the PK of Tenofovir (TFV) and Emtricitabine (FTC)
  • To evaluate the safety, tolerability, and efficacy of F/TAF through week ninety-six (96)

Eligibility overview

  • HIV-1 infected male and female adolescents and children aged 1 month to < 18 years at baseline/Day 1
  • Participant is currently on a stable 2-NRTI (TDF containing) regimen that includes a protocol specified 3rd ARV agent for greater than or equal to six (6) consecutive months prior to screening
  • Participant does not have an acquired immunodeficiency syndrome (AIDS) indicator condition with onset within thirty (30) days prior to screening
  • Participant has life expectancy of greater than two (2) years
  • Participant does not have evidence of active pulmonary or extra-pulmonary tuberculosis disease within three (3) months of the screening visit
  • Participant does not have history of significant drug sensitivity or drug allergy

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Overview

Full title:

A Phase 2/3, Open-Label Multi- Cohort Switch Study to Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected Children and Adolescents Virologically Suppressed on a Tenofovir Disoproxil Fumarate (TDF)-Containing Regimen

Study goal:

The purpose of this study is to determine the pharmacokinetics (PK) of the study drug in your body, the safety and tolerability of the study drug, and the antiviral activity of the study drug in children when combined with a third antiretroviral (ARV) medication

Diagnosis:

HIV/AIDS

Age:

1 month to 17 years

Clinical trials categories:

Human Immunodeficiency Virus (HIV) Infection Infectious Diseases

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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