Last updated on January 2020

B/F/TAF FDC in HIV-1 Infected Virologically Suppressed Adolescents and Children


Are you eligible to participate in this study?

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

  • Conditions: HIV-1 Infection
  • Age: Between 2 - 17 Years
  • Gender: Male or Female

Key Inclusion Criteria:

Cohort 1: HIV-1 infected adolescents (12 to < 18 years of age and screening weight 35 kg) who are virologically suppressed for 6 months prior to screening.

Cohort 2: HIV-1 infected children (6 to < 12 years of age and screening weight 25 kg) who are virologically suppressed for 6 months prior to screening.

Cohort 3: HIV-1 infected children ( 2 years of age and screening weight of 14 to < 25 kg) who are virologically suppressed for 6 months prior to screening.

  • Documented plasma HIV-1 RNA < 50 copies/mL on a stable regimen (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is 50 copies/mL) for 6 months preceding the Screening visit. Unconfirmed virologic elevations of 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL (eg, < 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests.
  • Stable antiretroviral regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) in combination with a third agent for a minimum of 6 months prior to the screening visit. Individuals undergoing dose modifications to their antiretroviral regimen for growth or who are switching medication formulation(s) are considered to be on a stable antiretroviral regimen.
  • Estimated glomerular filtration rate (GFR) 90 mL/min/1.73 m^2 according to the Schwartz Formula
  • No documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), or integrase strand transfer inhibitors (INSTIs) including, but not limited to, the reverse transcriptase resistance mutations K65R and M184V/I

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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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