Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients

Completed · Phase 4

Conditions studied: HIV, Pediatric

In brief

The purpose of this study is to collect safety clinical data in HIV-infected pediatric patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are receiving atazanavir capsule boosted with ritonavir and an optimized nucleoside reverse transcriptase inhibitor backbone therapy as part of their antiretroviral regimen.

Key facts

Study ID

NCT01691794

Run by

Bristol-Myers Squibb

People needed

108

Starts

2012-11-30

Expected to finish

2017-02-20

Last updated by the study team

2018-04-27

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• First degree atrioventricular (AV) block, as defined by protocol
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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