Last updated on October 2020

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

Are you eligible to participate in this study?

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

  • Conditions: Immunodeficiency | Primary Immunodeficiency Disorders | AIDS and AIDS related infections | AIDS | HIV Infections | Acquired Immune Deficiency Syndrome (AIDS - Pediatric) | HIV infection
  • Age: Between 3 - 17 Years
  • Gender: Male or Female

Key Inclusion Criteria:

  • 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.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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