Summary

Eligibility
for people ages 1 month to 17 years (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

The primary objective of this study is to confirm the TAF dose and to evaluate the pharmacokinetics (PK) of TAF, safety, and tolerability of F/TAF in HIV-1 infected children and adolescents virologically suppressed (defined as having < 50 copies/mL of HIV-1 ribonucleic acid [RNA] for a period of at least 6 months) while on a stable NRTI containing regimen.

Official 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 2-NRTI-Containing Regimen

Details

Cohorts 2, 3, and 4 will be on a boosted protease inhibitor (PI) or any other 3rd antiretroviral (ARV) agent and will switch their current 2-NRTI-containing regimen to open-label F/TAF while continuing their boosted PI or 3rd agent through 48 weeks. A minimum of 10 participants each in Groups 1 and 2 of Cohort 2, and Cohorts 3 and 4, who are on boosted-atazanavir (ATV) as their 3rd ARV agent will be enrolled. Participants in Cohort 2, Group 1 receive boosted PI agents only. Cohorts 2, 3, and 4 will be enrolled by cohort into a two-part study (Parts A and B).

After completion of 48 weeks, all participants will be given the option to participate in an extension phase of the study. Gilead will provide F/TAF until a) The participant turns 18 years old and F/TAF is commercially available for use in adults in the country in which the participant is enrolled or b), F/TAF becomes commercially available for pediatric use in the country in which the participant is enrolled or c), Gilead Sciences elects to terminate development of F/TAF in the applicable country.

Keywords

HIV-1, emtricitabine, FTC, tenofovir, TDF, antiretroviral, adolescents, children, pediatric, F/TAF, 3rd ARV agent, Boosted PIs

Eligibility

You can join if…

Open to people ages 1 month to 17 years

  • HIV-1 infected male and female adolescents and children aged 1 month to < 18 years at baseline/Day 1 (according to requirements of the enrolling cohort)
  • Must be able to give written assent prior to any screening evaluations
  • Parent or guardian able to give written informed consent prior to any screening evaluations and willing to comply with study requirements
  • Body weight at screening as follows:
    • Cohort 1: ≥ 35 kg
    • Cohort 2, Group 1: ≥ 25 kg
    • Cohort 2, Group 2: 17 kg to < 25 kg
    • Cohort 3: to be updated per a protocol amendment
    • Cohort 4: to be updated per a protocol amendment
  • Currently on a stable 2-NRTI containing regimen that includes a 3rd ARV agent for ≥ 6 consecutive months prior to screening
  • Plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 consecutive months preceding the screening visit
  • No opportunistic infection within 30 days of study entry (at baseline/Day 1)
  • A negative serum β-human chorionic gonadotropin (HCG) pregnancy test is required for females of childbearing potential only

You CAN'T join if...

  • An acquired immunodeficiency syndrome (AIDS) - indicator condition with onset within 30 days prior to screening
  • Life expectancy of < 2 years
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline/Day 1
  • Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit
  • Active hepatitis C virus (HCV) infection defined as positive for HCV antibody and having detectable HCV RNA
  • Positive hepatitis B surface antigen or other evidence of active hepatitis B virus (HBV) infection.
  • Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with treatment, assessment, or compliance with the protocol.
  • Pregnant or lactating females
  • Have history of significant drug sensitivity or drug allergy
  • Have previously participated in an investigational trial involving administration of any investigational agent, other than tenofovir, within 30 days prior to the study dosing

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Locations

  • University of California Los Angeles
    Los Angeles California 90095 United States
  • Children's Hospital Colorado
    Aurora Colorado 80045 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Gilead Clinical Trials Website
ID
NCT02285114
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
About 41 people participating
Last Updated