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

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, Initial Version, June 23, 2014

Category:

Infectious Diseases

Diseases Treated:

HIV/AIDS

Eligibility Overview:

  • Participant is HIV-1 infected male or female aged six (6) to less than eight-teen (18) years of age at Baseline.
  • 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.

Description

This study will be enrolling 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: (among others)

  • Participant is HIV-1 infected male or female aged six (6) to less than eight-teen (18) years of age at Baseline.
  • 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.

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Aditya Gaur, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.