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Safety Sudy of Atazanavir Capsules in the Treatment of HIV in Patients Ages 6 - 18 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01691794
First received: September 21, 2012
Last updated: November 20, 2014
Last verified: July 2013

September 21, 2012
November 20, 2014
November 2012
October 2014   (final data collection date for primary outcome measure)
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 [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01691794 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Sudy of Atazanavir Capsules in the Treatment of HIV in Patients Ages 6 - 18 Years
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 Infected, Antiretroviral Naive and Experienced Pediatric Subjects Greater Than or Equal to 6 Years to Less Than 18 Years

The purpose of AI424452 is to collect safety clinical data in human immunodeficiency virus (HIV) infected pediatric subjects ≥ 6 years to < 18 years of age and ≥ 15 kg who are receiving Atazanavir (ATV) capsule boosted with Ritonavir (RTV) capsule or tablet formulations and an optimized nucleoside reverse transcriptase inhibitor (NRTI) backbone therapy as part of their Antiretroviral (ARV) regimen.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV, Pediatric
  • Drug: Atazanavir
    Other Names:
    • Reyataz
    • BMS-232632
  • Drug: Ritonavir
    Other Name: Norvir
Experimental: Atazanavir + Ritonavir
  • Atazanavir Capsule Dosed by weight 15- <20 kg = 150 mg, 20- <40 kg = 200 mg, <40 kg = 300 mg by mouth (Oral) once per day for 24 weeks or until a local pediatric ATV approval
  • Ritonavir 100mg/mL capsule or tablet by mouth (Oral) once per day for 24 weeks or until a local pediatric ATV approval
Interventions:
  • Drug: Atazanavir
  • Drug: Ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
October 2014
October 2014   (final data collection date for primary outcome measure)

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 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

Exclusion Criteria:

  • 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):

    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 virus (HBV) or hepatitis C virus (HCV)
Both
6 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Chile,   Mexico,   Peru,   Russian Federation,   South Africa
 
NCT01691794
AI424-452, 2011-003300-21
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP