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Trial Outcomes & Findings for Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients (NCT NCT01335698)

NCT ID: NCT01335698

Last Updated: 2018-11-09

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

160 participants

Primary outcome timeframe

Day one to week 300 (approximately 22-Jan-2018)

Results posted on

2018-11-09

Participant Flow

Of 160 participants enrolled, 99 received treatment.

Participant milestones

Participant milestones
Measure
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)
Stage 1: HIV-infected pediatric patients weighing 15 to \<25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Treatment Stage 1
STARTED
23
12
21
35
8
Treatment Stage 1
COMPLETED
15
4
16
26
6
Treatment Stage 1
NOT COMPLETED
8
8
5
9
2
Treatment Stage 2
STARTED
15
4
16
26
6
Treatment Stage 2
COMPLETED
4
1
11
18
5
Treatment Stage 2
NOT COMPLETED
11
3
5
8
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)
Stage 1: HIV-infected pediatric patients weighing 15 to \<25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Treatment Stage 1
Lack of Efficacy
3
1
3
3
1
Treatment Stage 1
Adverse Event
1
2
2
1
1
Treatment Stage 1
Withdrawal by Subject
1
2
0
1
0
Treatment Stage 1
Lost to Follow-up
1
1
0
0
0
Treatment Stage 1
Poor compliance/noncompliance
0
1
0
2
0
Treatment Stage 1
No longer meets study criteria
1
1
0
1
0
Treatment Stage 1
Other
1
0
0
1
0
Treatment Stage 2
Lack of Efficacy
2
1
3
1
0
Treatment Stage 2
Adverse Event
2
0
0
3
0
Treatment Stage 2
Withdrawal by Subject
3
1
1
0
0
Treatment Stage 2
Poor compliance/noncompliance
1
0
1
3
1
Treatment Stage 2
Lost to Follow-up
1
0
0
0
0
Treatment Stage 2
Capsules received at state hospital
1
0
0
0
0
Treatment Stage 2
Subject no longer meets study criteria
0
0
0
1
0
Treatment Stage 2
Switched to another formulation
1
1
0
0
0

Baseline Characteristics

Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=23 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=12 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)
n=21 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)
n=35 Participants
Stage 1: HIV-infected pediatric patients weighing 15 to \<25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
n=8 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Total
n=99 Participants
Total of all reporting groups
Age, Continuous
8.4 Months
STANDARD_DEVIATION 6.42 • n=5 Participants
10.5 Months
STANDARD_DEVIATION 9.21 • n=7 Participants
37.4 Months
STANDARD_DEVIATION 12.44 • n=5 Participants
67.2 Months
STANDARD_DEVIATION 16.70 • n=4 Participants
93.4 Months
STANDARD_DEVIATION 15.53 • n=21 Participants
42.5 Months
STANDARD_DEVIATION 31.58 • n=10 Participants
Sex: Female, Male
Female
12 Participants
n=5 Participants
6 Participants
n=7 Participants
12 Participants
n=5 Participants
18 Participants
n=4 Participants
3 Participants
n=21 Participants
51 Participants
n=10 Participants
Sex: Female, Male
Male
11 Participants
n=5 Participants
6 Participants
n=7 Participants
9 Participants
n=5 Participants
17 Participants
n=4 Participants
5 Participants
n=21 Participants
48 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
4 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
4 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
22 Participants
n=5 Participants
10 Participants
n=7 Participants
18 Participants
n=5 Participants
33 Participants
n=4 Participants
8 Participants
n=21 Participants
91 Participants
n=10 Participants
Race/Ethnicity, Customized
White
2 Participants
n=5 Participants
2 Participants
n=7 Participants
12 Participants
n=5 Participants
13 Participants
n=4 Participants
3 Participants
n=21 Participants
32 Participants
n=10 Participants
Race/Ethnicity, Customized
Black/African American
19 Participants
n=5 Participants
6 Participants
n=7 Participants
7 Participants
n=5 Participants
20 Participants
n=4 Participants
5 Participants
n=21 Participants
57 Participants
n=10 Participants
Race/Ethnicity, Customized
Other
2 Participants
n=5 Participants
4 Participants
n=7 Participants
2 Participants
n=5 Participants
2 Participants
n=4 Participants
0 Participants
n=21 Participants
10 Participants
n=10 Participants
Region of Enrollment
North America
2 Participants
n=5 Participants
1 Participants
n=7 Participants
9 Participants
n=5 Participants
4 Participants
n=4 Participants
2 Participants
n=21 Participants
18 Participants
n=10 Participants
Region of Enrollment
South America
1 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
4 Participants
n=4 Participants
1 Participants
n=21 Participants
8 Participants
n=10 Participants
Region of Enrollment
Africa
20 Participants
n=5 Participants
10 Participants
n=7 Participants
8 Participants
n=5 Participants
21 Participants
n=4 Participants
5 Participants
n=21 Participants
64 Participants
n=10 Participants
Region of Enrollment
Europe
0 Participants
n=5 Participants
0 Participants
n=7 Participants
3 Participants
n=5 Participants
6 Participants
n=4 Participants
0 Participants
n=21 Participants
9 Participants
n=10 Participants
Country
Argentina
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
2 Participants
n=4 Participants
0 Participants
n=21 Participants
4 Participants
n=10 Participants
Country
Brazil
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=10 Participants
Country
Chile
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
3 Participants
n=10 Participants
Country
Mexico
1 Participants
n=5 Participants
1 Participants
n=7 Participants
7 Participants
n=5 Participants
4 Participants
n=4 Participants
2 Participants
n=21 Participants
15 Participants
n=10 Participants
Country
Poland
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=10 Participants
Country
Romania
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=10 Participants
Country
Russia
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
3 Participants
n=4 Participants
0 Participants
n=21 Participants
4 Participants
n=10 Participants
Country
South Africa
20 Participants
n=5 Participants
10 Participants
n=7 Participants
8 Participants
n=5 Participants
21 Participants
n=4 Participants
5 Participants
n=21 Participants
64 Participants
n=10 Participants
Country
Spain
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
2 Participants
n=4 Participants
0 Participants
n=21 Participants
3 Participants
n=10 Participants
Country
United States
1 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
3 Participants
n=10 Participants

PRIMARY outcome

Timeframe: Day one to week 300 (approximately 22-Jan-2018)

Population: All participants who received at least 1 dose of study drug

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.

Outcome measures

Outcome measures
Measure
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=23 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=12 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)
n=21 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)
n=35 Participants
Stage 1: HIV-infected pediatric patients weighing 15 to \<25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
n=8 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder
Rash
3 Participants
0 Participants
4 Participants
5 Participants
1 Participants
Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder
Deaths
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder
AEs leading to discontinuation
3 Participants
2 Participants
2 Participants
2 Participants
1 Participants
Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder
Hyperbilirubinemia related adverse events
2 Participants
0 Participants
9 Participants
7 Participants
0 Participants
Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder
Jaundice
0 Participants
0 Participants
3 Participants
3 Participants
0 Participants
Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder
Atrioventricular block, first degree
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder
Tachycardia
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Day one to week 300 (approximately 22-Jan-2018)

SAE= any of the the following: is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event (defined as a medical event(s) that may not be immediately life threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the subject or may require intervention \[eg, medical, surgical\] to prevent one of the other serious outcomes listed in the definition above.) Examples of such events include, but are not limited to, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization

Outcome measures

Outcome measures
Measure
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=23 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=12 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)
n=21 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)
n=35 Participants
Stage 1: HIV-infected pediatric patients weighing 15 to \<25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
n=8 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Number of Participants Who Experienced a SAE on ATV Powder
6 participants
3 participants
8 participants
8 participants
0 participants

PRIMARY outcome

Timeframe: Day one to week 300 (approximately 22-Jan-2018)

Population: All participants who received at least 1 dose of study drug.

The CDC disease staging system assesses the severity of HIV disease by CD4 cell counts and by the presence of specific HIV-related conditions. CD4 counts are classified as 1: ≥500 cells/µL, 2: 200-499 cells/µL, and 3: \<200 cells/µL. Children with HIV infection are also classified in each of several categories. Category N: Not symptomatic. Category A: Mildly symptomatic. Category B: Moderately symptomatic. Category C: Severely symptomatic.

Outcome measures

Outcome measures
Measure
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=23 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=12 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)
n=21 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)
n=35 Participants
Stage 1: HIV-infected pediatric patients weighing 15 to \<25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
n=8 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder
Pulmonary tuberculosis
2 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder
Lymph node tuberculosis
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder
Tuberculosis
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder
Oropharyngeal Candidiasis
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Day one to week 300 (approximately 22-Jan-2018)

Population: All participants who received at least 1 dose of study drug. n=number of participants evaluable

Criteria of the Division of AIDS for grading the severity of adult and pediatric adverse events as follows: Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=potentially life-threatening. Neutrophils (absolute) (adult and infants \>7 days): Gr 1=1.000-1300/mm\^3; Gr 2=750-999 mm\^3; Gr 3=500-749 mm\^3; Gr 4= \<500 mm\^3. Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase: Gr 1=1.25-2.5\*upper limit of normal (ULN); Gr 2=2.6-5.0\*ULN; Gr 3=5.1-10.0\*ULN; Gr 4= \>10.0\*ULN. Bilirubin, total (adults and infants \>14 days): Gr 1=1.1-1.5\*ULN; Gr 2=1.6-2.5\*ULN; Gr 3=2.6-5.0\*ULN; Gr 4= \>5.0\*ULN. Lipase: Gr 1=1.1-1.5\*ULN; Gr 2=1.6-3.0\*ULN; Gr 3=3.1-5.0\*ULN; Gr 4= \>5.0\*ULN. Bicarbonate, serum low: Gr 1=16.0 mEq/L-\<lower limit of normal; Gr 2=11.0-15.9 mEq/L; Gr 3=8.0-10.9 mEq/L; Gr 4= \<8 mEq/L. By criteria of the World Health Organization: Amylase: Gr 1=1.0-1.39\*ULN; Gr 2=1.40-2.09\*ULN; Gr 3.=2.10-5.0\*ULN; Gr 4= \>5.0\*ULN.

Outcome measures

Outcome measures
Measure
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=23 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=12 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)
n=21 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)
n=35 Participants
Stage 1: HIV-infected pediatric patients weighing 15 to \<25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
n=8 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder
Neutrophils (absolute)
0 Participants
0 Participants
4 Participants
6 Participants
0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder
Alanine aminotransferase
4 Participants
1 Participants
1 Participants
2 Participants
0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder
Aspartate aminotransferase
2 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder
Alkaline phosphatase
1 Participants
2 Participants
1 Participants
0 Participants
0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder
Total bilirubin
4 Participants
1 Participants
10 Participants
5 Participants
2 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder
Amylase
15 Participants
7 Participants
6 Participants
6 Participants
1 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder
Lipase
3 Participants
2 Participants
0 Participants
2 Participants
1 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder
Bicarbonate
2 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder
Albumin
1 Participants
1 Participants
0 Participants
1 Participants
0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder
Calcium, High
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder
Chloride, Low
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder
Total Cholesterol, Fasting
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder
LDL Cholesterol, Fasting
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder
Glucose, Fasting, Low
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Day 1 of treatment to weeks 24 and 48

Population: For efficacy of atazanavir powder to Week 24: Atazanavir Powder Cohort. For efficacy of atazanavir powder efficacy to Week 48 (n): Eligible Week 48 Atazanavir Powder Cohort

Virologic success includes patients with HIV RNA \<50 copies/mL. Two cohorts were assessed: The Atazanavir Powder Cohort=patients who received treatment and did not switch to capsule before analysis Week 24 or before their HIV RNA Week 24 assessment, and the Eligible Week 48 Atazanavir Powder Cohort=patients who initiated study treatment at least 48 weeks before last person last visit and did not switch to capsule before analysis Week 48 or before their HIV RNA Week 48 assessment.

Outcome measures

Outcome measures
Measure
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=23 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=12 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)
n=21 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)
n=35 Participants
Stage 1: HIV-infected pediatric patients weighing 15 to \<25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
n=8 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort
Week 24: HIV RNA<50 copies/mL
10 Participants
2 Participants
10 Participants
19 Participants
5 Participants
Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort
Week 24: HIV RNA<400 copies/mL
15 Participants
5 Participants
15 Participants
24 Participants
6 Participants
Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort
Week 48: HIV RNA<50 copies/mL
11 Participants
0 Participants
6 Participants
18 Participants
1 Participants
Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort
Week 48:HIV RNA<400 copies/mL
14 Participants
1 Participants
14 Participants
22 Participants
1 Participants

SECONDARY outcome

Timeframe: Baseline to Weeks 24 and 48

Population: All participants who received at least 1 dose of study drug. n=participants with both baseline and time point results

Human immunodeficiency virus ribonucleic acid (HIV RNA) change from baseline using observed values

Outcome measures

Outcome measures
Measure
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=23 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=12 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)
n=21 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)
n=35 Participants
Stage 1: HIV-infected pediatric patients weighing 15 to \<25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
n=8 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Mean Change From Baseline in HIV RNA on ATV Powder
Week 24
-2.10 Log copies per millileter
Standard Error 0.2863
-3.07 Log copies per millileter
Standard Error 0.4780
-2.69 Log copies per millileter
Standard Error 0.2257
-2.66 Log copies per millileter
Standard Error 0.1550
-2.24 Log copies per millileter
Standard Error 0.3821
Mean Change From Baseline in HIV RNA on ATV Powder
Week 48
-2.31 Log copies per millileter
Standard Error 0.3174
-4.06 Log copies per millileter
Standard Error 0.1649
-2.91 Log copies per millileter
Standard Error 0.1883
-2.70 Log copies per millileter
Standard Error 0.1269
-3.97 Log copies per millileter
Standard Error NA
Only 1 participant in this arm was eligible for evaluation at this time point

SECONDARY outcome

Timeframe: Baseline to Weeks 24 and 48

Population: All participants with both baseline and time point results; n=number of participants evaluable at time point

Change in CD4 percent using observed values

Outcome measures

Outcome measures
Measure
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=23 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=12 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)
n=21 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)
n=35 Participants
Stage 1: HIV-infected pediatric patients weighing 15 to \<25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
n=8 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Mean Change From Baseline in CD4 Percent on ATV Powder
Week 24
5.1 Percent Change
Standard Error 1.521
4.0 Percent Change
Standard Error 1.581
5.4 Percent Change
Standard Error 2.448
6.3 Percent Change
Standard Error 1.280
-0.3 Percent Change
Standard Error 4.349
Mean Change From Baseline in CD4 Percent on ATV Powder
Week 48
2.8 Percent Change
Standard Error 3.167
—
8.9 Percent Change
Standard Error 2.182
7.5 Percent Change
Standard Error 1.825
1.0 Percent Change
Standard Error NA
Only one participant was analyzed

SECONDARY outcome

Timeframe: Baseline to Weeks 24 and 48

Population: All participants with both baseline and time point results

CD4 cell count change from baseline using observed values

Outcome measures

Outcome measures
Measure
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=10 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=1 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)
n=13 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)
n=27 Participants
Stage 1: HIV-infected pediatric patients weighing 15 to \<25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
n=8 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
CD4 Cell Count Changes From Baseline on ATV Powder
Week 24
218.7 Cells/mm^3
Standard Error 259.102
67.8 Cells/mm^3
Standard Error 425.659
247.1 Cells/mm^3
Standard Error 110.739
246.1 Cells/mm^3
Standard Error 72.044
145.8 Cells/mm^3
Standard Error 78.443
CD4 Cell Count Changes From Baseline on ATV Powder
Week 48
-409.8 Cells/mm^3
Standard Error 437.686
—
400.0 Cells/mm^3
Standard Error 156.021
335.4 Cells/mm^3
Standard Error 108.925
213.0 Cells/mm^3
Standard Error NA
Only one participant was analyzed

SECONDARY outcome

Timeframe: Baseline through Week 48

Population: All participants with virologic failure.

Newly emergent substitutions are on-treatment substitutions that were not detected at baseline.Viral rebound in the resistance analysis was defined as: Less than a 1 log10 drop from baseline in plasma HIV RNA level by Week 16, confirmed by a second plasma HIV RNA level redrawn within 2 and 4 weeks from original sample. Or, a plasma HIV RNA level \>200 c/mL after Week 24, confirmed by a second plasma HIV RNA level redrawn within 2 and 4 weeks from original sample. Or, repeated plasma HIV RNA level ≥50 c/mL after Week 48. Viral rebound was defined as a plasma HIV RNA level ≥400 c/mL at any time in a patient who had previously achieved a plasma HIV RNA level \<50 c/mL. Or, a plasma HIV RNA level ≥50 c/mL and \<1,000 c/mL followed by a return to virologic suppression was considered a viral blip and not a viral rebound. NRTI=nucleoside reverse transcriptase inhibitor

Outcome measures

Outcome measures
Measure
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=10 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=2 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)
n=10 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)
n=13 Participants
Stage 1: HIV-infected pediatric patients weighing 15 to \<25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
n=1 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48
Any PI substitutions
4 Participants
0 Participants
4 Participants
3 Participants
0 Participants
Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48
Any IAS-USA PI substitutions
1 Participants
0 Participants
2 Participants
0 Participants
0 Participants
Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48
Any select RT substitutions
2 Participants
1 Participants
2 Participants
1 Participants
0 Participants
Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48
NRTI
1 Participants
1 Participants
2 Participants
1 Participants
0 Participants

SECONDARY outcome

Timeframe: Baseline to Week 2

To describe the PK profile of ATV powder formulation with RTV in pediatric subjects weighing 25 - \< 35 kg and/or 6 to \< 11 years of age and for the new 5 - \< 10 kg cohort (200 mg ATV and 80 mg RTV) in terms of ATV Cmax

Outcome measures

Outcome measures
Measure
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=12 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=17 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)
n=8 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)
Stage 1: HIV-infected pediatric patients weighing 15 to \<25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Maximum Observed Plasma Concentration (Cmax)
5776.70 ng/mL
Standard Deviation 3417.208
5644.12 ng/mL
Standard Deviation 3093.516
4893.75 ng/mL
Standard Deviation 2523.959
—
—

SECONDARY outcome

Timeframe: Baseline to Week 2

To describe the PK profile of ATV powder formulation with RTV in pediatric subjects weighing 25 - \< 35 kg and/or 6 to \< 11 years of age and for the new 5 - \< 10 kg cohort (200 mg ATV and 80 mg RTV) in terms of ATV Cmin

Outcome measures

Outcome measures
Measure
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=12 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=17 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)
n=8 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)
Stage 1: HIV-infected pediatric patients weighing 15 to \<25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Minimum Plasma Concentration (Cmin)
718.90 ng/mL
Standard Deviation 432.747
857.06 ng/mL
Standard Deviation 599.221
1030.64 ng/mL
Standard Deviation 1070.932
—
—

SECONDARY outcome

Timeframe: Baseline to Week 2

To describe the PK profile of ATV powder formulation with RTV in pediatric subjects weighing 25 - \< 35 kg and/or 6 to \< 11 years of age and for the new 5 - \< 10 kg cohort (200 mg ATV and 80 mg RTV) in terms of ATV AUC

Outcome measures

Outcome measures
Measure
Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=12 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)
n=17 Participants
Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)
n=8 Participants
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)
Stage 1: HIV-infected pediatric patients weighing 15 to \<25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
Area Under the Concentration-Time Curve [AUC(TAU)]
49387.12 ng.h./mL
Standard Deviation 26890.782
59671.80 ng.h./mL
Standard Deviation 31706.655
56356.00 ng.h./mL
Standard Deviation 35233.024
—
—

Adverse Events

B/L Weight 5 to lt 10kg (ATV 150mg)

Serious events: 6 serious events
Other events: 22 other events
Deaths: 0 deaths

B/L Weight 5 to lt 10kg (ATV 200mg)

Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths

B/L Weight 10 to lt 15kg

Serious events: 8 serious events
Other events: 19 other events
Deaths: 0 deaths

B/L Weight 15 to lt 25kg

Serious events: 10 serious events
Other events: 31 other events
Deaths: 0 deaths

B/L Weight 25 to lt 35kg

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
B/L Weight 5 to lt 10kg (ATV 150mg)
n=23 participants at risk
B/L Weight 5 to lt 10kg (ATV 200mg)
n=12 participants at risk
B/L Weight 10 to lt 15kg
n=21 participants at risk
B/L Weight 15 to lt 25kg
n=35 participants at risk
B/L Weight 25 to lt 35kg
n=8 participants at risk
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/23
0.00%
0/12
4.8%
1/21
0.00%
0/35
0.00%
0/8
Blood and lymphatic system disorders
Neutropenia
0.00%
0/23
0.00%
0/12
0.00%
0/21
2.9%
1/35
0.00%
0/8
Gastrointestinal disorders
Pancreatitis acute
4.3%
1/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Gastrointestinal disorders
Vomiting
0.00%
0/23
0.00%
0/12
4.8%
1/21
0.00%
0/35
0.00%
0/8
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/23
0.00%
0/12
0.00%
0/21
2.9%
1/35
0.00%
0/8
Immune system disorders
Immune reconstitution inflammatory syndrome
0.00%
0/23
0.00%
0/12
0.00%
0/21
2.9%
1/35
0.00%
0/8
Infections and infestations
Cellulitis
4.3%
1/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Dysentery
4.3%
1/23
0.00%
0/12
4.8%
1/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Gastroenteritis
4.3%
1/23
8.3%
1/12
4.8%
1/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Hepatitis a
4.3%
1/23
0.00%
0/12
0.00%
0/21
2.9%
1/35
0.00%
0/8
Infections and infestations
Infective corneal ulcer
0.00%
0/23
0.00%
0/12
4.8%
1/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Lower respiratory tract infection
4.3%
1/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Otitis media
0.00%
0/23
0.00%
0/12
4.8%
1/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Pertussis
0.00%
0/23
8.3%
1/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Pulmonary tuberculosis
0.00%
0/23
8.3%
1/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Sinusitis
4.3%
1/23
0.00%
0/12
4.8%
1/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Tonsillitis
0.00%
0/23
0.00%
0/12
0.00%
0/21
2.9%
1/35
0.00%
0/8
Injury, poisoning and procedural complications
Overdose
0.00%
0/23
0.00%
0/12
0.00%
0/21
5.7%
2/35
0.00%
0/8
Injury, poisoning and procedural complications
Pneumonitis chemical
0.00%
0/23
8.3%
1/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Investigations
Alanine aminotransferase increased
0.00%
0/23
0.00%
0/12
4.8%
1/21
5.7%
2/35
0.00%
0/8
Investigations
Aspartate aminotransferase increased
0.00%
0/23
0.00%
0/12
4.8%
1/21
0.00%
0/35
0.00%
0/8
Investigations
Blood bilirubin increased
0.00%
0/23
0.00%
0/12
0.00%
0/21
2.9%
1/35
0.00%
0/8
Investigations
Transaminases increased
4.3%
1/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Reproductive system and breast disorders
Varicocele
0.00%
0/23
0.00%
0/12
4.8%
1/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Varicella
0.00%
0/23
0.00%
0/12
4.8%
1/21
0.00%
0/35
0.00%
0/8
Injury, poisoning and procedural complications
Accidental exposure to product
4.3%
1/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
0.00%
0/8

Other adverse events

Other adverse events
Measure
B/L Weight 5 to lt 10kg (ATV 150mg)
n=23 participants at risk
B/L Weight 5 to lt 10kg (ATV 200mg)
n=12 participants at risk
B/L Weight 10 to lt 15kg
n=21 participants at risk
B/L Weight 15 to lt 25kg
n=35 participants at risk
B/L Weight 25 to lt 35kg
n=8 participants at risk
Blood and lymphatic system disorders
Lymphadenopathy
4.3%
1/23
8.3%
1/12
9.5%
2/21
14.3%
5/35
0.00%
0/8
Blood and lymphatic system disorders
Anaemia
34.8%
8/23
16.7%
2/12
0.00%
0/21
5.7%
2/35
0.00%
0/8
Blood and lymphatic system disorders
Basophilia
0.00%
0/23
0.00%
0/12
9.5%
2/21
0.00%
0/35
0.00%
0/8
Blood and lymphatic system disorders
Leukopenia
0.00%
0/23
0.00%
0/12
9.5%
2/21
0.00%
0/35
0.00%
0/8
Blood and lymphatic system disorders
Neutropenia
4.3%
1/23
0.00%
0/12
9.5%
2/21
2.9%
1/35
0.00%
0/8
Blood and lymphatic system disorders
Thrombocytopenia
8.7%
2/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Blood and lymphatic system disorders
Thrombocytosis
8.7%
2/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Ear and labyrinth disorders
Ear pain
0.00%
0/23
0.00%
0/12
9.5%
2/21
5.7%
2/35
0.00%
0/8
Endocrine disorders
Goitre
0.00%
0/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
12.5%
1/8
Eye disorders
Conjunctivitis allergic
0.00%
0/23
0.00%
0/12
0.00%
0/21
5.7%
2/35
12.5%
1/8
Eye disorders
Iritis
0.00%
0/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
12.5%
1/8
Eye disorders
Myopia
0.00%
0/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
12.5%
1/8
Gastrointestinal disorders
Abdominal pain
0.00%
0/23
0.00%
0/12
9.5%
2/21
0.00%
0/35
0.00%
0/8
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/23
0.00%
0/12
0.00%
0/21
2.9%
1/35
12.5%
1/8
Gastrointestinal disorders
Dental caries
17.4%
4/23
8.3%
1/12
14.3%
3/21
11.4%
4/35
0.00%
0/8
Gastrointestinal disorders
Diarrhoea
26.1%
6/23
0.00%
0/12
14.3%
3/21
8.6%
3/35
12.5%
1/8
Gastrointestinal disorders
Dyspepsia
0.00%
0/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
12.5%
1/8
Gastrointestinal disorders
Nausea
0.00%
0/23
0.00%
0/12
0.00%
0/21
2.9%
1/35
12.5%
1/8
Gastrointestinal disorders
Toothache
0.00%
0/23
0.00%
0/12
0.00%
0/21
8.6%
3/35
0.00%
0/8
Gastrointestinal disorders
Vomiting
30.4%
7/23
8.3%
1/12
28.6%
6/21
25.7%
9/35
37.5%
3/8
General disorders
Asthenia
0.00%
0/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
25.0%
2/8
General disorders
Chest pain
0.00%
0/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
12.5%
1/8
General disorders
Pyrexia
13.0%
3/23
0.00%
0/12
38.1%
8/21
11.4%
4/35
37.5%
3/8
Hepatobiliary disorders
Hyperbilirubinaemia
8.7%
2/23
0.00%
0/12
28.6%
6/21
5.7%
2/35
12.5%
1/8
Hepatobiliary disorders
Jaundice
0.00%
0/23
0.00%
0/12
14.3%
3/21
8.6%
3/35
0.00%
0/8
Hepatobiliary disorders
Ocular icterus
4.3%
1/23
0.00%
0/12
9.5%
2/21
2.9%
1/35
0.00%
0/8
Infections and infestations
Acarodermatitis
26.1%
6/23
0.00%
0/12
4.8%
1/21
8.6%
3/35
0.00%
0/8
Infections and infestations
Body tinea
0.00%
0/23
25.0%
3/12
0.00%
0/21
5.7%
2/35
0.00%
0/8
Infections and infestations
Bronchitis
8.7%
2/23
0.00%
0/12
9.5%
2/21
8.6%
3/35
0.00%
0/8
Infections and infestations
Bronchitis bacterial
0.00%
0/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
12.5%
1/8
Infections and infestations
Candida nappy rash
34.8%
8/23
16.7%
2/12
4.8%
1/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Conjunctivitis
8.7%
2/23
0.00%
0/12
4.8%
1/21
11.4%
4/35
0.00%
0/8
Infections and infestations
Ear infection
0.00%
0/23
0.00%
0/12
9.5%
2/21
5.7%
2/35
0.00%
0/8
Infections and infestations
Fungal skin infection
4.3%
1/23
8.3%
1/12
0.00%
0/21
2.9%
1/35
0.00%
0/8
Infections and infestations
Gastroenteritis
60.9%
14/23
25.0%
3/12
52.4%
11/21
22.9%
8/35
25.0%
2/8
Infections and infestations
Helminthic infection
30.4%
7/23
16.7%
2/12
0.00%
0/21
2.9%
1/35
0.00%
0/8
Infections and infestations
Impetigo
30.4%
7/23
0.00%
0/12
9.5%
2/21
5.7%
2/35
12.5%
1/8
Infections and infestations
Influenza
4.3%
1/23
0.00%
0/12
9.5%
2/21
11.4%
4/35
12.5%
1/8
Infections and infestations
Lower respiratory tract infection
30.4%
7/23
41.7%
5/12
4.8%
1/21
2.9%
1/35
12.5%
1/8
Infections and infestations
Nasopharyngitis
8.7%
2/23
0.00%
0/12
38.1%
8/21
17.1%
6/35
0.00%
0/8
Infections and infestations
Oral candidiasis
39.1%
9/23
33.3%
4/12
4.8%
1/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Oral herpes
8.7%
2/23
8.3%
1/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Otitis externa
0.00%
0/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
12.5%
1/8
Infections and infestations
Otitis media
26.1%
6/23
25.0%
3/12
0.00%
0/21
8.6%
3/35
12.5%
1/8
Infections and infestations
Otitis media acute
30.4%
7/23
0.00%
0/12
0.00%
0/21
8.6%
3/35
12.5%
1/8
Infections and infestations
Pharyngitis
8.7%
2/23
0.00%
0/12
28.6%
6/21
20.0%
7/35
12.5%
1/8
Infections and infestations
Pharyngotonsillitis
4.3%
1/23
0.00%
0/12
4.8%
1/21
2.9%
1/35
12.5%
1/8
Infections and infestations
Pneumonia
17.4%
4/23
8.3%
1/12
4.8%
1/21
5.7%
2/35
0.00%
0/8
Infections and infestations
Pulmonary tuberculosis
8.7%
2/23
0.00%
0/12
4.8%
1/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Respiratory tract infection viral
0.00%
0/23
0.00%
0/12
4.8%
1/21
5.7%
2/35
0.00%
0/8
Infections and infestations
Sinusitis
0.00%
0/23
0.00%
0/12
9.5%
2/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Tinea capitis
30.4%
7/23
8.3%
1/12
14.3%
3/21
11.4%
4/35
0.00%
0/8
Infections and infestations
Tonsillitis
13.0%
3/23
8.3%
1/12
4.8%
1/21
8.6%
3/35
12.5%
1/8
Infections and infestations
Tooth abscess
0.00%
0/23
0.00%
0/12
9.5%
2/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Upper respiratory tract infection
69.6%
16/23
41.7%
5/12
23.8%
5/21
28.6%
10/35
25.0%
2/8
Infections and infestations
Urinary tract infection
13.0%
3/23
8.3%
1/12
0.00%
0/21
5.7%
2/35
12.5%
1/8
Infections and infestations
Varicella
0.00%
0/23
0.00%
0/12
9.5%
2/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Varicella zoster virus infection
0.00%
0/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
12.5%
1/8
Infections and infestations
Viral infection
0.00%
0/23
0.00%
0/12
9.5%
2/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Viral upper respiratory tract infection
13.0%
3/23
8.3%
1/12
9.5%
2/21
5.7%
2/35
0.00%
0/8
Injury, poisoning and procedural complications
Arthropod bite
17.4%
4/23
0.00%
0/12
0.00%
0/21
2.9%
1/35
12.5%
1/8
Injury, poisoning and procedural complications
Foreign body in ear
4.3%
1/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
12.5%
1/8
Injury, poisoning and procedural complications
Overdose
0.00%
0/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
12.5%
1/8
Injury, poisoning and procedural complications
Thermal burn
8.7%
2/23
0.00%
0/12
0.00%
0/21
2.9%
1/35
0.00%
0/8
Investigations
Alanine aminotransferase increased
8.7%
2/23
0.00%
0/12
0.00%
0/21
5.7%
2/35
0.00%
0/8
Investigations
Amylase increased
8.7%
2/23
8.3%
1/12
4.8%
1/21
0.00%
0/35
12.5%
1/8
Investigations
Blood alkaline phosphatase increased
8.7%
2/23
0.00%
0/12
4.8%
1/21
0.00%
0/35
0.00%
0/8
Investigations
Head lag
8.7%
2/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Investigations
Lipase increased
4.3%
1/23
8.3%
1/12
4.8%
1/21
0.00%
0/35
0.00%
0/8
Investigations
Transaminases increased
8.7%
2/23
0.00%
0/12
4.8%
1/21
2.9%
1/35
0.00%
0/8
Investigations
Weight decreased
4.3%
1/23
16.7%
2/12
0.00%
0/21
2.9%
1/35
12.5%
1/8
Metabolism and nutrition disorders
Decreased appetite
4.3%
1/23
8.3%
1/12
4.8%
1/21
5.7%
2/35
12.5%
1/8
Metabolism and nutrition disorders
Hypercholesterolaemia
0.00%
0/23
0.00%
0/12
23.8%
5/21
0.00%
0/35
0.00%
0/8
Metabolism and nutrition disorders
Hypertriglyceridaemia
0.00%
0/23
0.00%
0/12
9.5%
2/21
0.00%
0/35
0.00%
0/8
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
0.00%
0/23
0.00%
0/12
0.00%
0/21
5.7%
2/35
0.00%
0/8
Nervous system disorders
Headache
0.00%
0/23
0.00%
0/12
9.5%
2/21
8.6%
3/35
25.0%
2/8
Nervous system disorders
Lethargy
0.00%
0/23
0.00%
0/12
0.00%
0/21
5.7%
2/35
0.00%
0/8
Product Issues
Product taste abnormal
0.00%
0/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
12.5%
1/8
Psychiatric disorders
Pica
8.7%
2/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Renal and urinary disorders
Haematuria
4.3%
1/23
8.3%
1/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Renal and urinary disorders
Proteinuria
8.7%
2/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Respiratory, thoracic and mediastinal disorders
Asthma
0.00%
0/23
0.00%
0/12
19.0%
4/21
2.9%
1/35
0.00%
0/8
Respiratory, thoracic and mediastinal disorders
Cough
13.0%
3/23
16.7%
2/12
0.00%
0/21
28.6%
10/35
25.0%
2/8
Respiratory, thoracic and mediastinal disorders
Nasal congestion
21.7%
5/23
33.3%
4/12
0.00%
0/21
11.4%
4/35
0.00%
0/8
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
4.3%
1/23
8.3%
1/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
12.5%
1/8
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
0.00%
0/23
8.3%
1/12
14.3%
3/21
2.9%
1/35
0.00%
0/8
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
21.7%
5/23
0.00%
0/12
9.5%
2/21
8.6%
3/35
12.5%
1/8
Skin and subcutaneous tissue disorders
Dermatitis
0.00%
0/23
0.00%
0/12
0.00%
0/21
5.7%
2/35
0.00%
0/8
Skin and subcutaneous tissue disorders
Dermatitis allergic
8.7%
2/23
0.00%
0/12
0.00%
0/21
2.9%
1/35
12.5%
1/8
Skin and subcutaneous tissue disorders
Dermatitis atopic
0.00%
0/23
0.00%
0/12
0.00%
0/21
2.9%
1/35
25.0%
2/8
Skin and subcutaneous tissue disorders
Dermatitis diaper
21.7%
5/23
25.0%
3/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Skin and subcutaneous tissue disorders
Dry skin
4.3%
1/23
0.00%
0/12
0.00%
0/21
5.7%
2/35
0.00%
0/8
Skin and subcutaneous tissue disorders
Eczema
21.7%
5/23
16.7%
2/12
9.5%
2/21
8.6%
3/35
0.00%
0/8
Skin and subcutaneous tissue disorders
Rash
0.00%
0/23
0.00%
0/12
9.5%
2/21
5.7%
2/35
0.00%
0/8
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
13.0%
3/23
8.3%
1/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/23
0.00%
0/12
4.8%
1/21
0.00%
0/35
12.5%
1/8
Skin and subcutaneous tissue disorders
Urticaria chronic
0.00%
0/23
0.00%
0/12
0.00%
0/21
0.00%
0/35
12.5%
1/8
Congenital, familial and genetic disorders
Dysmorphism
0.00%
0/23
8.3%
1/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Eye disorders
Strabismus
0.00%
0/23
8.3%
1/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Gastrointestinal disorders
Constipation
0.00%
0/23
8.3%
1/12
4.8%
1/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Fungal infection
0.00%
0/23
8.3%
1/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Skin candida
0.00%
0/23
8.3%
1/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Skin infection
0.00%
0/23
8.3%
1/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Infections and infestations
Viral rash
0.00%
0/23
8.3%
1/12
0.00%
0/21
0.00%
0/35
0.00%
0/8
Skin and subcutaneous tissue disorders
Dermatitis contact
0.00%
0/23
8.3%
1/12
0.00%
0/21
2.9%
1/35
0.00%
0/8
Skin and subcutaneous tissue disorders
Miliaria
0.00%
0/23
8.3%
1/12
0.00%
0/21
0.00%
0/35
0.00%
0/8

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

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