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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 4

Conditions: HIV, Pediatric

Treatments: Drug: Ritonavir; Drug: Atazanavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01691794

AI424-452

2011-003300-21 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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-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

• 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:

  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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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108 participants in 3 patient groups

Atazanavir, 150 mg + Ritonavir, 100 mg (weight:15 to <20 kg)

Active Comparator group

Description:

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.

Treatment:

Drug: Atazanavir

Drug: Ritonavir

Atazanavir, 200 mg + Ritonavir, 100 mg (weight: 20 to <40 kg)

Active Comparator group

Description:

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.

Treatment:

Drug: Atazanavir

Drug: Ritonavir

Atazanavir, 300 mg + Ritonavir, 100 mg (weight: ≥ 40 kg)

Active Comparator group

Description:

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.

Treatment:

Drug: Atazanavir

Drug: Ritonavir