Trial Outcomes & Findings for Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients (NCT NCT01691794)

Last Updated: 2018-04-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

108 participants

Primary outcome timeframe

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

Results posted on

2018-04-27

Participant Flow

Overall, 108 participants were enrolled, and 59 received treatment.

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	3	33	23
Overall Study COMPLETED	2	15	13
Overall Study NOT COMPLETED	1	18	10

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.
Overall Study Poor/Non-Compliance	1	4	1
Overall Study Death	0	0	1
Overall Study Lack of Efficacy	0	7	1
Overall Study Participant request to discontinue	0	1	0
Overall Study Adverse Event	0	1	1
Overall Study Completed Only first 24 weeks of study	0	2	3
Overall Study Did not complete first 24 weeks of study	0	3	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) n=3 Participants 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.	Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) n=33 Participants 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.	Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) n=23 Participants 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.	Total n=59 Participants Total of all reporting groups
Age, Continuous	6.0 Years STANDARD_DEVIATION 0.0 • n=5 Participants	10.7 Years STANDARD_DEVIATION 2.67 • n=7 Participants	14.7 Years STANDARD_DEVIATION 1.72 • n=5 Participants	12.0 Years STANDARD_DEVIATION 3.26 • n=4 Participants
Age, Customized	6.0 Years n=5 Participants	11.0 Years n=7 Participants	15.0 Years n=5 Participants	12.0 Years n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	17 Participants n=7 Participants	11 Participants n=5 Participants	30 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	16 Participants n=7 Participants	12 Participants n=5 Participants	29 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	30 Participants n=7 Participants	19 Participants n=5 Participants	51 Participants n=4 Participants
Race/Ethnicity, Customized White	1 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized Black/African American	2 Participants n=5 Participants	24 Participants n=7 Participants	9 Participants n=5 Participants	35 Participants n=4 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants	14 Participants n=4 Participants
Region of Enrollment Africa	2 Participants n=5 Participants	24 Participants n=7 Participants	8 Participants n=5 Participants	34 Participants n=4 Participants
Region of Enrollment Europe	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment North America	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment South America	0 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants	20 Participants n=4 Participants
Country Argentina	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Country Brazil	0 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants
Country Chile	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Country Mexico	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Country Peru	0 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants
Country Russia	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Country South Africa	2 Participants n=5 Participants	24 Participants n=7 Participants	8 Participants n=5 Participants	34 Participants n=4 Participants
Country United States	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) n=3 Participants 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.	Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) n=33 Participants 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.	Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) n=23 Participants 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.
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	0 Participants	1 Participants
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	3 Participants	4 Participants
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	1 Participants	2 Participants
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	3 Participants	5 Participants
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	3 Participants	5 Participants
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	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) n=3 Participants 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.	Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) n=33 Participants 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.	Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) n=23 Participants 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.
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 Hemoglobin	0 Participants	5 Participants	0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 Hematocrit	0 Participants	3 Participants	0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 Platelets	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 White blood cells	0 Participants	3 Participants	0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 Neutrophils+bands (absolute)	1 Participants	13 Participants	4 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 ALT	1 Participants	6 Participants	9 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 AST	0 Participants	6 Participants	5 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 ALP	1 Participants	11 Participants	12 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 Total bilirubin	3 Participants	26 Participants	17 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 Albumin	2 Participants	15 Participants	6 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 Amylase	2 Participants	27 Participants	14 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 Lipase	0 Participants	15 Participants	8 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) n=3 Participants 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.	Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) n=33 Participants 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.	Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) n=23 Participants 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.
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) Calcium, high	0 Participants	2 Participants	0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) Blood urea nitrogen	0 Participants	3 Participants	0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) Uric acid	0 Participants	2 Participants	3 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) Bicarbonate, low	3 Participants	29 Participants	17 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) Calcium, low	0 Participants	2 Participants	3 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) Potassium, high	0 Participants	2 Participants	1 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) Potassium, low	0 Participants	2 Participants	0 Participants
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	10 Participants	6 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) Sodium, low	1 Participants	13 Participants	0 Participants
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	7 Participants	3 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) Glucose, low (n=1, 11, 9)	0 Participants	3 Participants	0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) Glucose, fasting, high (3, 31, 22)	0 Participants	3 Participants	1 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) Sodium, high	0 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) Creatinine	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) Triglycerides, fasting	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) Chloride, high	0 Participants	0 Participants	2 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) Chloride, low	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) Glucose, Non-Fasting, High	0 Participants	0 Participants	0 Participants

Adverse Events

B/L Weight 15 to Less Than 20 kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

B/L Weight 20 to Less Than 40 kg

Serious events: 3 serious events

Other events: 26 other events

Deaths: 0 deaths

B/L Weight Greater Than and Equal 40 kg

Serious events: 4 serious events

Other events: 20 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	B/L Weight 15 to Less Than 20 kg n=3 participants at risk 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.	B/L Weight 20 to Less Than 40 kg n=33 participants at risk 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.	B/L Weight Greater Than and Equal 40 kg n=23 participants at risk 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.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	4.3% 1/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Infections and infestations Appendicitis	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	4.3% 1/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Infections and infestations Meningitis bacterial	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	4.3% 1/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Injury, poisoning and procedural complications Accidental overdose	33.3% 1/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Injury, poisoning and procedural complications Overdose	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	3.0% 1/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Nervous system disorders Seizure	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	3.0% 1/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Psychiatric disorders Abnormal behaviour	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	4.3% 1/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Renal and urinary disorders Glomerulonephritis	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	3.0% 1/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Renal and urinary disorders Haematuria	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	3.0% 1/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Renal and urinary disorders Post streptococcal glomerulonephritis	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	3.0% 1/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)

Other adverse events

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email:

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	B/L Weight 15 to Less Than 20 kg n=3 participants at risk 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.	B/L Weight 20 to Less Than 40 kg n=33 participants at risk 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.	B/L Weight Greater Than and Equal 40 kg n=23 participants at risk 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.
Cardiac disorders Atrioventricular block first degree	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	9.1% 3/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Cardiac disorders Sinus bradycardia	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	6.1% 2/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	8.7% 2/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	3.0% 1/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	21.7% 5/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	9.1% 3/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	4.3% 1/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Gastrointestinal disorders Nausea	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	6.1% 2/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	17.4% 4/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Gastrointestinal disorders Toothache	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	9.1% 3/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Gastrointestinal disorders Vomiting	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	21.2% 7/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	13.0% 3/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	6.1% 2/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	17.4% 4/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Hepatobiliary disorders Jaundice	33.3% 1/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	6.1% 2/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	26.1% 6/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Hepatobiliary disorders Ocular icterus	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	3.0% 1/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	13.0% 3/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Infections and infestations Bronchitis	33.3% 1/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	6.1% 2/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Infections and infestations Conjunctivitis	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	6.1% 2/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	8.7% 2/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Infections and infestations Gastroenteritis	33.3% 1/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	9.1% 3/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Infections and infestations Impetigo	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	3.0% 1/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	8.7% 2/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Infections and infestations Influenza	33.3% 1/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	9.1% 3/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	13.0% 3/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Infections and infestations Nasopharyngitis	33.3% 1/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	9.1% 3/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	26.1% 6/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Infections and infestations Oral herpes	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	12.1% 4/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	4.3% 1/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Infections and infestations Otitis media	33.3% 1/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	6.1% 2/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	8.7% 2/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Infections and infestations Tonsillitis	33.3% 1/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	12.1% 4/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Infections and infestations Upper respiratory tract infection	66.7% 2/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	39.4% 13/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	17.4% 4/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Nervous system disorders Headache	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	12.1% 4/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	8.7% 2/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Psychiatric disorders Depression	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	6.1% 2/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	4.3% 1/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	27.3% 9/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	17.4% 4/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	6.1% 2/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	4.3% 1/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Skin and subcutaneous tissue disorders Acne	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	3.0% 1/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	8.7% 2/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	12.1% 4/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	12.1% 4/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	8.7% 2/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Ear and labyrinth disorders Ear pain	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	6.1% 2/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	6.1% 2/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
General disorders Pyrexia	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	6.1% 2/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Infections and infestations Abscess	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	6.1% 2/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Infections and infestations Pharyngitis	33.3% 1/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	3.0% 1/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Infections and infestations Pharyngotonsillitis	33.3% 1/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Infections and infestations Urinary tract infection	33.3% 1/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	3.0% 1/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Injury, poisoning and procedural complications Head injury	33.3% 1/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Psychiatric disorders Hallucination	33.3% 1/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	8.7% 2/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	8.7% 2/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	33.3% 1/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Skin and subcutaneous tissue disorders Eczema	0.00% 0/3 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	6.1% 2/33 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)	0.00% 0/23 • From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)