Last updated on August 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: HIV-1
  • Age: Between 1 - 17 Years
  • Gender: Male or Female

Key Inclusion Criteria:

  • 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 -human chorionic gonadotropin (HCG) pregnancy test is required for females of childbearing potential only

Key Exclusion Criteria:

  • 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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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