Study Evaluating Pharmacokinetics (PK) Safety and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected Virologically Suppressed Pediatric Participants

  • STATUS
    Recruiting
  • End date
    Apr 2, 2026
  • participants needed
    100
  • sponsor
    Gilead Sciences
Updated on 2 November 2020
Investigator
Gilead Study Team
Primary Contact
The George Washington University (5.4 mi away) Contact
+34 other location
antiretroviral agents
tenofovir
tuberculosis
emtricitabine
cobicistat
emtricitabine/tenofovir
ritonavir
darunavir
atazanavir

Summary

Cohort 1:

The primary objectives are:

  • To evaluate the steady-state pharmacokinetics (PK) of Atazanavir (ATV) and Darunavir (DRV) and confirm the dose of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) in HIV-1 infected, virologically suppressed adolescent participants weighing 25 kg (12 to < 18 years of age)
  • To evaluate the safety and tolerability of ATV/co or DRV/co through 24 weeks in HIV-1 infected, virologically suppressed adolescent participants weighing 25 kg (12 to < 18 years of age)

Cohort 2:

The primary objectives are:

  • To evaluate the steady-state PK of ATV and DRV and confirm the dose of ATV/co or DRV/co in HIV-1 infected pediatric participants weighing 25 to < 35 kg (6 to < 12 years of age)
  • To evaluate the steady-state PK of tenofovir alafenamide (TAF) and confirm the dose of emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected pediatric participants weighing 25 to < 35 kg (6 to < 12 years of age)
  • To evaluate the safety and tolerability of ATV/co, DRV/co, and F/TAF through 24 weeks in HIV-1 infected pediatric participants weighing 25 to < 35 kg (6 to < 12 years of age)

Cohort 3:

The primary objectives are:

  • To evaluate the steady-state PK of ATV and DRV and confirm the dose of ATV/co or DRV/co in HIV-1 infected pediatric participants weighing 14 to < 25 kg ( 3 years of age)
  • To evaluate the steady-state PK of TAF and confirm the dose of F/TAF in HIV-1 infected pediatric participants weighing 14 to < 25 kg ( 3 years of age)
  • To evaluate the safety and tolerability of ATV/co, DRV/co, and F/TAF through 24 weeks in HIV-1 infected pediatric participants weighing 14 to < 25 kg ( 3 years of age)

Details
Treatment ATV, DRV, Cobicistat, BR, BR
Clinical Study IdentifierNCT02016924
SponsorGilead Sciences
Last Modified on2 November 2020

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Eligibility

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Inclusion Criteria

Is your age between 3 yrs and 17 yrs?
Gender: Male or Female
Do you have any of these conditions: Immunodeficiency or Acquired Immune Deficiency Syndrome (AIDS - Pediatric) or AIDS or Primary Immunodeficiency Disorders or HIV Infections or HIV infe...?
HIV-1 infected treatment-experienced, virologically suppressed males and females aged 3 years to < 18 years at the Day 1 visit (according to requirements of enrolling Cohort)
Body weight at screening 25 kg (Cohorts 1), 14 kg to < 25 kg (Cohort 3)
Stable antiretroviral regimen including 2 nucleoside reverse transcriptase inhibitors and either ritonavir-boosted atazanavir or ritonavir-boosted darunavir once or twice daily as per product label for a minimum of 3 months prior to the screening visit. Treatment-experienced pediatric individuals taking DRV/r must have no history of DRV resistance associated mutations
Documented negative screening for active pulmonary tuberculosis (TB) per local standard of care within 6 months of a screening visit
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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