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

Bristol-Myers Squibb108 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

108

Conditions

HIV, Pediatric

Interventions

AtazanavirDRUG

RitonavirDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (27)

Phoenix Children'S Hospital

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

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

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.

Time frame: From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)

Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4

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.

Time frame: After first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)

Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued)

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.

Data from ClinicalTrials.gov

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