HIV, Pediatric
Conditions
Brief summary
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.
Interventions
DRUGAtazanavir
DRUGRitonavir
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months) | 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 | After first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months) | 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) | After first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months) | 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. |
Countries
Argentina, Brazil, Chile, Mexico, Peru, Russia, South Africa, United States
Participant flow
Pre-assignment details
Overall, 108 participants were enrolled, and 59 received treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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 in capsule formation 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 were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years. | 3 |
| 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 were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years. | 33 |
| 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 were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years. | 23 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 |
| Overall Study | Completed Only first 24 weeks of study | 0 | 2 | 3 |
| Overall Study | Death | 0 | 0 | 1 |
| Overall Study | Did not complete first 24 weeks of study | 0 | 3 | 3 |
| Overall Study | Lack of Efficacy | 0 | 7 | 1 |
| Overall Study | Participant request to discontinue | 0 | 1 | 0 |
| Overall Study | Poor/Non-Compliance | 1 | 4 | 1 |
Baseline characteristics
| Characteristic | Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Total | Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) |
|---|---|---|---|---|
| Age, Continuous | 10.7 Years STANDARD_DEVIATION 2.67 | 12.0 Years STANDARD_DEVIATION 3.26 | 6.0 Years STANDARD_DEVIATION 0 | 14.7 Years STANDARD_DEVIATION 1.72 |
| Age, Customized | 11.0 Years | 12.0 Years | 6.0 Years | 15.0 Years |
| Country Argentina | 3 Participants | 3 Participants | 0 Participants | 0 Participants |
| Country Brazil | 3 Participants | 7 Participants | 0 Participants | 4 Participants |
| Country Chile | 1 Participants | 3 Participants | 0 Participants | 2 Participants |
| Country Mexico | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Country Peru | 1 Participants | 7 Participants | 0 Participants | 6 Participants |
| Country Russia | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Country South Africa | 24 Participants | 34 Participants | 2 Participants | 8 Participants |
| Country United States | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 5 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 30 Participants | 51 Participants | 2 Participants | 19 Participants |
| Race/Ethnicity, Customized Black/African American | 24 Participants | 35 Participants | 2 Participants | 9 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 14 Participants | 0 Participants | 10 Participants |
| Race/Ethnicity, Customized White | 5 Participants | 10 Participants | 1 Participants | 4 Participants |
| Region of Enrollment Africa | 24 Participants | 34 Participants | 2 Participants | 8 Participants |
| Region of Enrollment Europe | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Region of Enrollment North America | 0 Participants | 4 Participants | 1 Participants | 3 Participants |
| Region of Enrollment South America | 8 Participants | 20 Participants | 0 Participants | 12 Participants |
| Sex: Female, Male Female | 17 Participants | 30 Participants | 2 Participants | 11 Participants |
| Sex: Female, Male Male | 16 Participants | 29 Participants | 1 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 33 | 1 / 23 |
| other Total, other adverse events | 3 / 3 | 26 / 33 | 20 / 23 |
| serious Total, serious adverse events | 1 / 3 | 3 / 33 | 4 / 23 |
Outcome results
Primary
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)
Population: All participants who received at least 1 dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | 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 | Grade 3-4 AEs | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | 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 | AEs leading to discontinuation | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | 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 | CDC Class C AIDS events | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | 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 | Deaths | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | 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 | Grade 2-4 related AEs | 1 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | 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 | SAEs | 1 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | 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 | Grade 2-4 related AEs | 3 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | 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 | SAEs | 3 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | 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 | CDC Class C AIDS events | 1 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | 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 | Deaths | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | 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 | Grade 3-4 AEs | 3 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | 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 | AEs leading to discontinuation | 1 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | 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 | CDC Class C AIDS events | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | 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 | Deaths | 1 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | 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 | SAEs | 4 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | 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 | AEs leading to discontinuation | 2 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | 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 | Grade 2-4 related AEs | 5 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | 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 | Grade 3-4 AEs | 5 Participants |
Primary
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)
Population: All participants who received at least 1 dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Hemoglobin | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Neutrophils+bands (absolute) | 1 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Amylase | 2 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Hematocrit | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | ALT | 1 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | White blood cells | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Lipase | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | AST | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Albumin | 2 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Platelets | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | ALP | 1 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Total bilirubin | 3 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | ALP | 11 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Total bilirubin | 26 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Albumin | 15 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Amylase | 27 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Lipase | 15 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | White blood cells | 3 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Neutrophils+bands (absolute) | 13 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Hemoglobin | 5 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | ALT | 6 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Hematocrit | 3 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | AST | 6 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Platelets | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Lipase | 8 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Hematocrit | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Hemoglobin | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Platelets | 1 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | White blood cells | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Neutrophils+bands (absolute) | 4 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | ALT | 9 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | AST | 5 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | ALP | 12 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Total bilirubin | 17 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Amylase | 14 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Albumin | 6 Participants |
Primary
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.
Time frame: After first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Population: All participants who received at least 1 dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Potassium, high | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Blood urea nitrogen | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | LDL cholesterol, fasting (n=3, 31, 21) | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Potassium, low | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Sodium, low | 1 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Total cholesterol, fasting (n=3, 31, 21) | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Glucose, Non-Fasting, High | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Chloride, low | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Uric acid | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Sodium, high | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Chloride, high | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Bicarbonate, low | 3 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Glucose, fasting, high (3, 31, 22) | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Calcium, high | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Calcium, low | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Creatinine | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Glucose, low (n=1, 11, 9) | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Triglycerides, fasting | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Bicarbonate, low | 29 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Blood urea nitrogen | 3 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Uric acid | 2 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Calcium, low | 2 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Potassium, low | 2 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Potassium, high | 2 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Total cholesterol, fasting (n=3, 31, 21) | 10 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Sodium, low | 13 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | LDL cholesterol, fasting (n=3, 31, 21) | 7 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Glucose, low (n=1, 11, 9) | 3 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Glucose, fasting, high (3, 31, 22) | 3 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Calcium, high | 2 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Chloride, high | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Chloride, low | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Glucose, Non-Fasting, High | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Sodium, high | 1 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Creatinine | 1 Participants |
| Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Triglycerides, fasting | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Glucose, fasting, high (3, 31, 22) | 1 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Bicarbonate, low | 17 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Glucose, Non-Fasting, High | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Calcium, high | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Uric acid | 3 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Creatinine | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Blood urea nitrogen | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Total cholesterol, fasting (n=3, 31, 21) | 6 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Potassium, low | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Sodium, high | 1 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Sodium, low | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Potassium, high | 1 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Chloride, low | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | LDL cholesterol, fasting (n=3, 31, 21) | 3 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Calcium, low | 3 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Chloride, high | 2 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Glucose, low (n=1, 11, 9) | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Triglycerides, fasting | 0 Participants |