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

This study is currently recruiting participants.
Verified July 2013 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01691794
First received: September 21, 2012
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
HIV, Pediatric
Drug: Atazanavir
Drug: Ritonavir
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: November 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Atazanavir
Other Names:
  • Reyataz
  • BMS-232632
Drug: Ritonavir
Other Name: Norvir

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691794

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations
United States, Arizona
Phoenix Children'S Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Janice Piatt, Site 0032    602-546-0920      
United States, Georgia
Grady Health System Ponce Family And Youth Clinic Recruiting
Atlanta, Georgia, United States, 30322
Contact: Andres Camacho-Gonzalez, Site 0026         
United States, Texas
Local Institution Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Site 0034         
Argentina
Local Institution Recruiting
Buenos Aires, Bs As, Buenos Aires, Argentina, 1141
Contact: Site 0019         
Local Institution Not yet recruiting
Buenos Aires, Argentina, 1425
Contact: Site 0020         
Local Institution Recruiting
Buenos Aires, Argentina, 1181
Contact: Site 0018         
Brazil
Local Institution Not yet recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035
Contact: Site 0007         
Local Institution Not yet recruiting
Sao Paulo, Brazil, 01246
Contact: Site 0010         
Chile
Local Institution Recruiting
Santiago, Metropolitana, Chile, 8207257
Contact: Site 0006         
Local Institution Recruiting
Santiago, Metropolitana, Chile, 8380418
Contact: Site 0005         
Mexico
Local Institution Recruiting
Guadalajara, Jalisco, Mexico, 44280
Contact: Site 0021         
Local Institution Recruiting
Merida, Yucatan, Mexico, 97000
Contact: Site 0023         
Local Institution Recruiting
Puebla, Mexico, 72000
Contact: Site 0022         
Peru
Local Institution Active, not recruiting
Cercado, Lima, Peru, 1
Local Institution Recruiting
Lima, Peru, 1
Contact: Site 001         
Local Institution Recruiting
Lima, Peru, LIMA 10
Contact: Site 002         
Russian Federation
Local Institution Recruiting
Moscow, Russian Federation, 129110
Contact: Site 0029         
Local Institution Recruiting
St. Petersburg, Russian Federation, 190103
Contact: Site 0027         
South Africa
Local Institution Recruiting
Port Elizabeth, Eastern Cape, South Africa, 6001
Contact: Site 0013         
Local Institution Recruiting
Bloemfontein, Free State, South Africa, 9301
Contact: Site 0014         
Local Institution Recruiting
Bloemfontein, Free State, South Africa, 9301
Contact: Site 0011         
Local Institution Recruiting
Soweto, Gauteng, South Africa, 2013
Contact: Site 0015         
Local Institution Recruiting
Bellville, Cape Town, Western Cape, South Africa, 7530
Contact: Site 0012         
Local Institution Not yet recruiting
Cape Town, Western Cape, South Africa, 7505
Contact: Site 0016         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01691794     History of Changes
Other Study ID Numbers: AI424-452, 2011-003300-21
Study First Received: September 21, 2012
Last Updated: July 29, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ritonavir
Atazanavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014