A Prospective Single-Arm, Open-Label, International, Multicenter Study to Evaluate the Safety of Atazanavir (ATV) Capsule Boosted with Ritonavir (RTV) with an Optimized NRTI Background Therapy, in HIV Infefcted, Antiretroviral Naive and Experienced Pediatric Subjects Greater Than or Equal to 6 Years to Less than 18 Years.
The current study is a prospective, single arm, open-label, international, multicenter study to evaluate the safety of the approved doses of aTV capsule boosted with RTV capsule or tablet formulations and an optimized nRTi background therapy, in HiV infected, pediatric subjects [GreaterThanorequalTo] 6 years to [Less Than] 18 years of age. The proposed study, ai424452, is designed to reflect the current state of the HiV epidemic, subjects can be antiretroviral naive or experienced, providing they have no prior exposure to aTV. Treatment experienced subjects are defined by their previous exposure to antiretroviral drugs (aRVs) through either prior treatment for their HiV disease or through a post natal treatment with [GreaterThanorequalTo] 1 aRVs as part for the prevention of mother to child transmission (PMTCT).
in addition to the aTV/RTV medication, this study includes a nucleoside backbone therapy. This component of the treatment regimen will consist of 2 nRTis locally approved for pediatric use and dosed as per the local country label. This portion of the regimen will be determined by the investigator on the basis of the viral resistance profile of the subject, susceptibility profile of the nRTis being considered, and local guidelines for treatment of HiV infected children. if an nRTi is locally available only as a generic, it has to be locally approved for pediatric use. Background nRTis should remain unchanged through the duration of the study unless changes are required for treatment-limiting nRTi toxicity.
approximately 55 children will be treated with the aTV capsule formulation boosted with the RTV capsule or tablet formulation across all study sites. The study is 24 weeks in duration:
* in-clinic study visits will be at Screening, Day 1, Week 1 (phone call), Week 4, Week 8, Week 16, and Week 24.
* The study team will monitor the progress of subjects in their starting weight band.
* Dosing of aTV will be performed only with the capsule formulation, dosed according to weight. once a subject has qualified by weight to move to a higher weight band/higher dose, they will remain at that new dose regardless of any subsequent weight loss.
* Written Informed Consent and authorization of disclosure (HIPAA)
* Antiretroviral naive with a viral load >= 1000 copies/ml, or treatment experienced subjects with a viral load of >= 400 copies/ml.
* Confirmed HIV-1 infection diagnosed by 2 positive virologic test results including a HIV DNA PCR, or HIV ELISA with confirmatory Western blot or immunofluorescense antibody.
* Male or Female >= 6 years to < 17 years 6 months of age at the time of first treatment.
* Sexually active women of childbearing potential (WOCBP) must use highly effective methods of birth control and follow the instructions for birth control for the entire duration of the study including a minimum of 8 weeks after dosing is completed.
* WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product.
* Women must not be breastfeeding
* Sexually active fertile men must use highly effective birth control if their partners are WOCBP. Men that are sexually active with WOCBP must follow instructions for birth control for the entire duration of the study and a minimum of 8 weeks after dosing has been completed.
* Antiretroviral naive subjects must have genotypic sensitivity at screening to ATV and at least 2 NRTIs. NRTIs must be approved for pediatric use and dosed per the local country label.
* Antiretroviral experienced subjects must have documented genotypic and phenotypic sensitivity at screening to ATV (Fold Change in susceptibility < 2.2) and to at least 2 NRTIs.
* NRTIs must be approved for pediatric use and dosed per the local country label.