Safety Sudy of Atazanavir Capsules in the Treatment of HIV in Patients Ages 6 - 18 Years
- Conditions
- HIV in paediatric populationTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-003300-21-Outside-EU/EEA
- Lead Sponsor
- Bristol-Myers Squibb Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 113
•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 naive or treatment-experienced with a detectable viral load
•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 local country label
•Antiretroviral experienced subjects must have documented genotypic and phenotypic sensitivity at screening to ATV (Fold Change in susceptibility < 2.2) and at least 2 NRTIs. NRTIs must be approved for pediatric use and dosed per local country label
Are the trial subjects under 18? yes
Number of subjects for this age range: 113
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Experienced subjects who received Atazanavir (ATV) or ATV/RTV at any time prior to study enrollment
•Antiretroviral-naive or experienced HIV-1 infected subjects with contraindication to study medications
•Documented cardiac conduction abnormality(ies) or significant cardiac dysfunction, or a history syncope
•Family history of QTc interval syndrome, Brugada syndrome or right ventricular dysplasia or with a corrected QTc interval at screening of > 440 ms
•One of the following cardiac rhythm abnormalities documented on the screening electrocardiogram (ECG):
a.First degree atrioventricular (AV) block as defined by protocol
b.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 virus (HBV) or hepatitis C virus (HCV)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the safety and tolerability of ATV capsule boosted with RTV-based regimens in pediatric patients aged = 6 years to < 18 years dosed for 24 weeks.;Secondary Objective: Not applicable;Primary end point(s): Safety will be measured by frequency and severity of adverse events, serious adverse events (clinical and laboratory) and discontinuations from study due to adverse events;Timepoint(s) of evaluation of this end point: 24 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable