Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients
NCT ID: NCT01691794
Last Updated: 2018-04-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
108 participants
INTERVENTIONAL
2012-11-30
2017-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Atazanavir, 150 mg + Ritonavir, 100 mg (weight:15 to <20 kg)
Participants with baseline weight of 15 to \<20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
Atazanavir
Ritonavir
Atazanavir, 200 mg + Ritonavir, 100 mg (weight: 20 to <40 kg)
Participants with baseline weight of 20 to \<40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
Atazanavir
Ritonavir
Atazanavir, 300 mg + Ritonavir, 100 mg (weight: ≥ 40 kg)
Participants with baseline weight ≥ 40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
Atazanavir
Ritonavir
Interventions
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Atazanavir
Ritonavir
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
6 Years
17 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Phoenix Children'S Hospital
Phoenix, Arizona, United States
Grady Health System Ponce Family And Youth Clinic
Atlanta, Georgia, United States
Children'S Medical Center Of Dallas
Dallas, Texas, United States
Local Institution
Buenos Aires, Bs As, Buenos Aires, Argentina
Local Institution
Buenos Aires, , Argentina
Local Institution
Buenos Aires, , Argentina
Local Institution
Salvador, Estado de Bahia, Brazil
Local Institution
Salvador, Estado de Bahia, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
São Paulo, São Paulo, Brazil
Local Institution
São Paulo, , Brazil
Local Institution
Santiago, Santiago Metropolitan, Chile
Local Institution
Santiago, Santiago Metropolitan, Chile
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Monterrey, Nuevo León, Mexico
Local Institution
Mérida, Yucatán, Mexico
Local Institution
Puebla City, , Mexico
Local Institution
Lima, , Peru
Local Institution
Lima, , Peru
Local Institution
Moscow, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Port Elizabeth, Eastern Cape, South Africa
Local Institution
Bloemfontein, Free State, South Africa
Local Institution
Soweto, Gauteng, South Africa
Local Institution
Cape Town, Western Cape, South Africa
Local Institution
Cape Town, Western Cape, South Africa
Countries
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Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
BMS clinical trial educational resource
Other Identifiers
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2011-003300-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI424-452
Identifier Type: -
Identifier Source: org_study_id
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