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

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: February 8, 2016
Last verified: February 2016

September 21, 2012
February 8, 2016
November 2012
October 2014   (final data collection date for primary outcome measure)
  • Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Grade 2-4 Related AEs, Grade 3-4 AEs, and Centers for Disease Control (CDC) Class C AIDS Events [ Time Frame: Day 1 of treatment through Week 24 ] [ Designated as safety issue: Yes ]
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.
  • Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 [ Time Frame: Day 1 of treatment to Week 24 ] [ Designated as safety issue: Yes ]
    Hematocrit (%): Grade (Gr) 1= ≥28.5- <31.5; Gr 2= ≥24- <28.5; Gr 3= ≥19.5- <24; Gr 4= <19.5. Hemoglobin (g/dL): Grade (Gr)1=8.5-10.0; Gr 2=7.5-8.4; Gr 3=6.50-7.4; Gr 4= <6.5. Platelets (/mm^3): Gr 1=100,000-124,999; Gr 2=50,000-99,999; Gr 3=25,000-49,999; Gr 4= <25,000. White blood cells (/mm^3): Gr 1=2000-2500; Gr 2=1500-1999; Gr 3=1000-1499; Gr 4= <1000. Neutrophils (/mm^3): Gr 1=1000-1500; Gr 2= ≥750-1000; Gr 3= ≥500-750; Gr 4= <500. Alanine transaminase (ALT), alkaline phosphatase (ALP), aspartate transaminase (AST) (*upper limit of normal [ULN]): Gr 1=1.5-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10.0; Gr 4= >10.0. Total bilirubin (adult and pediatric >14 days) (*ULN): Gr 1=1.1-1.5; Gr 2=1.6-2.5; Gr 3=2.6-5.0; Gr 4= >5.0. Albumin (g/dL): Gr 1= 3.1- <LLN; Gr 2=2.0-2.9; Gr 3= <2.0; Gr 4=NA. Amylase (*ULN): Gr 1=1.10-1.39; Gr 2=1.40-2.09; Gr 3=2.10-5.0; Gr 4= >5. Lipase (*ULN): Gr 1=1.1-1.5; Gr 2=1.6-3.0; Gr 3=3.1-5.0; Gr 4= >5.0.
  • Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) [ Time Frame: Day 1 of treatment through Week 24 ] [ Designated as safety issue: Yes ]
    Blood urea nitrogen (*upper limit of normal [ULN]): Grade (Gr) 1=1.25-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10; Gr 4= >10. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12; Gr 3=12.1-15.0; Gr 4= >15.0. Bicarbonate (mEqL): Gr 1= 19.0-21.0; Gr 2=15.0-18.0; Gr 3=41-45; Gr 4= >45. Calcium, low (mg/dL): Gr 1=7.8-8.4; Gr 2=7.0-7.7; Gr 3=6.1-6.9; Gr 4= <6.1.Potassium (mEq/L), high: Gr 1=5.6-6.0; Gr 2=6.1-6.5; Gr 3=6.6-7.0; Gr 4= >7.0. Potassium (mEq/L), low: Gr 1=3.1-3.4; Gr 2=2.5-2.9; Gr 3=2.0-2.4; Gr 4= <2.0. Sodium (mEq/L), low: Gr 1=130-135; Gr 2=125-129; Gr 3=121-124; Gr 4= <1. Total cholesterol, fasting (mg/dL): Gr 1=200-239; Gr 2=240-300; Gr 3= >300; Gr 4=Not applicable (NA). Low-density lipoprotein (LDL) cholesterol, fasting (mg/dL): Gr 1=130-159; Gr 2=160-190; Gr 3= >190; Gr 4= NA. Glucose, low (mg/dL): Gr 1= 55-64; Gr 2=40-54; Gr 3=30-39; Gr 4= <30. Glucose, fasting (mg/dL): Gr 1=110-125; Gr 2=126-250; Gr 3=251-500; Gr 4 >500.
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 ]
Complete list of historical versions of study NCT01691794 on ClinicalTrials.gov Archive Site
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Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients
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 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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
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
  • Active Comparator: 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.
    Interventions:
    • Drug: Atazanavir
    • Drug: Ritonavir
  • Active Comparator: 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.
    Interventions:
    • Drug: Atazanavir
    • Drug: Ritonavir
  • Active Comparator: 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.
    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
108
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-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
Both
6 Years to 17 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
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
February 2016

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