Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT01691794
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT01691794
Study Brief:
Protocol Section:
NCT01691794