Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV in Patients Aged 6 to 18 Years

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: October 27, 2015
Last verified: October 2015

September 21, 2012
October 27, 2015
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, Cardiac Abnormalities, 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 in Patients Aged 6 to 18 Years
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 ≥6 to <18 years of age and ≥15 kg who are receiving atazanavir capsule boosted with ritonavir capsule or tablet formulations, with 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 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)
Both
6 Years to 18 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
October 2015

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