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 28, 2026
  • participants needed
    100
  • sponsor
    Gilead Sciences
Updated on 28 January 2021
antiretroviral
antiretroviral agents
tenofovir
tuberculosis
emtricitabine
cobicistat
emtricitabine/tenofovir
ritonavir
darunavir
atazanavir
HIV Vaccine

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
Condition HIV infection, Immunodeficiency, AIDS, HIV/AIDS, AIDS and AIDS related infections, Primary Immunodeficiency Disorders, Acquired Immune Deficiency Syndrome (AIDS - Pediatric), HIV Infections, human immunodeficiency virus, hiv disease, acquired immunodeficiency syndrome (aids), sida, acquired immune deficiency syndrome (aids)
Treatment ATV, DRV, Cobicistat, BR, BR
Clinical Study IdentifierNCT02016924
SponsorGilead Sciences
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

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...?
Do you have any of these conditions: human immunodeficiency virus or acquired immune deficiency syndrome (aids) or Primary Immunodeficiency Disorders or AIDS and AIDS related infections o...?
Do you have any of these conditions: Immunodeficiency or HIV/AIDS or Primary Immunodeficiency Disorders or HIV Infections or acquired immune deficiency syndrome (aids) or AIDS and AIDS re...?
Do you have any of these conditions: HIV Infections or AIDS or Primary Immunodeficiency Disorders or Immunodeficiency or Acquired Immune Deficiency Syndrome (AIDS - Pediatric) or HIV/AIDS...?
Do you have any of these conditions: Immunodeficiency or hiv disease or human immunodeficiency virus or AIDS and AIDS related infections or acquired immunodeficiency syndrome (aids) or HI...?
Do you have any of these conditions: acquired immune deficiency syndrome (aids) or Acquired Immune Deficiency Syndrome (AIDS - Pediatric) or hiv disease or acquired immunodeficiency syndr...?
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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