Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bristol-Myers Squibb
Age
6–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Confirmed HIV-1 infection diagnosed by protocol criteria
Male or female children, ≥ 6 years to \<17 years 6 months of age at the time of first treatment
Antiretroviral-naïve or treatment-experienced participants with a detectable viral load
Antiretroviral-naïve participants must have genotypic sensitivity at screening to atazanavir and at least 2 nucleoside reverse transcriptase inhibitors (NRTIs), which have been approved for pediatric use and dosed per local country label
Antiretroviral-experienced participants must have documented genotypic and phenotypic sensitivity at screening to atazanavir (fold change in susceptibility \<2.2) and at least 2 NRTIs, which have been approved for pediatric use and dosed per local country label.
You may not be if
Experienced participants who received atazanavir with or without ritonavir at any time prior to study enrollment
Antiretroviral-naive or -experienced HIV-1 infected patients with contraindication to study medications
Documented cardiac conduction abnormality, significant cardiac dysfunction, or a history syncope
Family history of QTc interval syndrome, Brugada syndrome, right ventricular dysplasia, or a corrected QTc interval of \>440 ms at screening
One of the following cardiac rhythm abnormalities documented on the screening electrocardiogram:
1. First degree atrioventricular (AV) block, as defined by protocol
2. Type I second degree AV block while awake, type II second degree AV block at any time, complete AV block at any time, or age-adjusted heart rate \<2nd percentile
Coinfection with either hepatitis B or C virus
Clareo Health | Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients