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Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients (PRINCE2)

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ClinicalTrials.gov Identifier: NCT01335698
Recruitment Status : Completed
First Posted : April 14, 2011
Results First Posted : February 8, 2016
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV
Interventions Drug: Atazanavir Sulphate
Drug: Ritonavir
Enrollment 160
Recruitment Details  
Pre-assignment Details Of 160 participants enrolled, 99 received treatment.
Arm/Group Title Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
Hide Arm/Group Description 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. 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. 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. 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. 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.
Period Title: Treatment Stage 1
Started 23 12 21 35 8
Completed 15 4 16 26 6
Not Completed 8 8 5 9 2
Reason Not Completed
Lack of Efficacy             3             1             3             3             1
Adverse Event             1             2             2             1             1
Withdrawal by Subject             1             2             0             1             0
Lost to Follow-up             1             1             0             0             0
Poor compliance/noncompliance             0             1             0             2             0
No longer meets study criteria             1             1             0             1             0
Other             1             0             0             1             0
Period Title: Treatment Stage 2
Started 15 4 16 26 6
Completed 4 1 11 18 5
Not Completed 11 3 5 8 1
Reason Not Completed
Lack of Efficacy             2             1             3             1             0
Adverse Event             2             0             0             3             0
Withdrawal by Subject             3             1             1             0             0
Poor compliance/noncompliance             1             0             1             3             1
Lost to Follow-up             1             0             0             0             0
Capsules received at state hospital             1             0             0             0             0
Subject no longer meets study criteria             0             0             0             1             0
Switched to another formulation             1             1             0             0             0
Arm/Group Title Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) Total
Hide Arm/Group Description 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. 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 23 12 21 35 8 99
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 23 participants 12 participants 21 participants 35 participants 8 participants 99 participants
8.4  (6.42) 10.5  (9.21) 37.4  (12.44) 67.2  (16.70) 93.4  (15.53) 42.5  (31.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 12 participants 21 participants 35 participants 8 participants 99 participants
Female
12
  52.2%
6
  50.0%
12
  57.1%
18
  51.4%
3
  37.5%
51
  51.5%
Male
11
  47.8%
6
  50.0%
9
  42.9%
17
  48.6%
5
  62.5%
48
  48.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 12 participants 21 participants 35 participants 8 participants 99 participants
Hispanic or Latino
0
   0.0%
1
   8.3%
2
   9.5%
1
   2.9%
0
   0.0%
4
   4.0%
Not Hispanic or Latino
1
   4.3%
1
   8.3%
1
   4.8%
1
   2.9%
0
   0.0%
4
   4.0%
Unknown or Not Reported
22
  95.7%
10
  83.3%
18
  85.7%
33
  94.3%
8
 100.0%
91
  91.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 12 participants 21 participants 35 participants 8 participants 99 participants
White
2
   8.7%
2
  16.7%
12
  57.1%
13
  37.1%
3
  37.5%
32
  32.3%
Black/African American
19
  82.6%
6
  50.0%
7
  33.3%
20
  57.1%
5
  62.5%
57
  57.6%
Other
2
   8.7%
4
  33.3%
2
   9.5%
2
   5.7%
0
   0.0%
10
  10.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 12 participants 21 participants 35 participants 8 participants 99 participants
North America
2
   8.7%
1
   8.3%
9
  42.9%
4
  11.4%
2
  25.0%
18
  18.2%
South America
1
   4.3%
1
   8.3%
1
   4.8%
4
  11.4%
1
  12.5%
8
   8.1%
Africa
20
  87.0%
10
  83.3%
8
  38.1%
21
  60.0%
5
  62.5%
64
  64.6%
Europe
0
   0.0%
0
   0.0%
3
  14.3%
6
  17.1%
0
   0.0%
9
   9.1%
Country  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 12 participants 21 participants 35 participants 8 participants 99 participants
Argentina
0
   0.0%
1
   8.3%
1
   4.8%
2
   5.7%
0
   0.0%
4
   4.0%
Brazil
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.9%
0
   0.0%
1
   1.0%
Chile
1
   4.3%
0
   0.0%
0
   0.0%
1
   2.9%
1
  12.5%
3
   3.0%
Mexico
1
   4.3%
1
   8.3%
7
  33.3%
4
  11.4%
2
  25.0%
15
  15.2%
Poland
0
   0.0%
0
   0.0%
1
   4.8%
0
   0.0%
0
   0.0%
1
   1.0%
Romania
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.9%
0
   0.0%
1
   1.0%
Russia
0
   0.0%
0
   0.0%
1
   4.8%
3
   8.6%
0
   0.0%
4
   4.0%
South Africa
20
  87.0%
10
  83.3%
8
  38.1%
21
  60.0%
5
  62.5%
64
  64.6%
Spain
0
   0.0%
0
   0.0%
1
   4.8%
2
   5.7%
0
   0.0%
3
   3.0%
United States
1
   4.3%
0
   0.0%
2
   9.5%
0
   0.0%
0
   0.0%
3
   3.0%
1.Primary Outcome
Title 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
Hide Description AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
Time Frame Day one to week 300 (approximately 22-Jan-2018)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug
Arm/Group Title Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 23 12 21 35 8
Measure Type: Number
Unit of Measure: Participants
Deaths 0 0 0 0 0
AEs leading to discontinuation 3 2 2 2 1
Hyperbilirubinemia related adverse events 2 0 9 7 0
Jaundice 0 0 3 3 0
Atrioventricular block, first degree 0 0 0 1 0
Tachycardia 0 0 1 0 0
Rash 3 0 4 5 1
2.Primary Outcome
Title Number of Participants Who Experienced a SAE on ATV Powder
Hide Description 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
Time Frame Day one to week 300 (approximately 22-Jan-2018)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 23 12 21 35 8
Measure Type: Number
Unit of Measure: participants
6 3 8 8 0
3.Primary Outcome
Title Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder
Hide Description 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.
Time Frame Day one to week 300 (approximately 22-Jan-2018)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug.
Arm/Group Title Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 23 12 21 35 8
Measure Type: Number
Unit of Measure: Participants
Pulmonary tuberculosis 2 0 1 0 0
Lymph node tuberculosis 0 0 0 1 0
Tuberculosis 0 0 0 1 0
Oropharyngeal Candidiasis 1 0 0 0 0
4.Primary Outcome
Title Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder
Hide Description 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.
Time Frame Day one to week 300 (approximately 22-Jan-2018)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug. n=number of participants evaluable
Arm/Group Title Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 23 12 21 35 8
Measure Type: Number
Unit of Measure: Participants
Neutrophils (absolute) Number Analyzed 23 participants 11 participants 21 participants 34 participants 8 participants
0 0 4 6 0
Alanine aminotransferase Number Analyzed 23 participants 12 participants 21 participants 34 participants 8 participants
4 1 1 2 0
Aspartate aminotransferase Number Analyzed 17 participants 12 participants 21 participants 34 participants 8 participants
2 0 1 0 0
Alkaline phosphatase Number Analyzed 23 participants 12 participants 21 participants 34 participants 8 participants
1 2 1 0 0
Total bilirubin Number Analyzed 23 participants 12 participants 21 participants 34 participants 8 participants
4 1 10 5 2
Amylase Number Analyzed 23 participants 12 participants 21 participants 34 participants 8 participants
15 7 6 6 1
Lipase Number Analyzed 23 participants 12 participants 21 participants 34 participants 8 participants
3 2 0 2 1
Bicarbonate Number Analyzed 23 participants 12 participants 21 participants 34 participants 8 participants
2 0 0 0 0
Albumin Number Analyzed 23 participants 12 participants 21 participants 34 participants 8 participants
1 1 0 1 0
Calcium, High Number Analyzed 23 participants 12 participants 21 participants 34 participants 8 participants
0 0 0 1 0
Chloride, Low Number Analyzed 23 participants 12 participants 21 participants 34 participants 8 participants
0 0 0 1 0
Total Cholesterol, Fasting Number Analyzed 11 participants 7 participants 15 participants 26 participants 6 participants
0 0 1 0 0
LDL Cholesterol, Fasting Number Analyzed 10 participants 3 participants 15 participants 26 participants 6 participants
0 0 1 0 0
Glucose, Fasting, Low Number Analyzed 14 participants 7 participants 17 participants 28 participants 8 participants
0 0 1 0 0
5.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 1 of treatment to weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 23 12 21 35 8
Measure Type: Number
Unit of Measure: Participants
Week 24: HIV RNA<50 copies/mL 10 2 10 19 5
Week 24: HIV RNA<400 copies/mL 15 5 15 24 6
Week 48: HIV RNA<50 copies/mL 11 0 6 18 1
Week 48:HIV RNA<400 copies/mL 14 1 14 22 1
6.Secondary Outcome
Title Mean Change From Baseline in HIV RNA on ATV Powder
Hide Description Human immunodeficiency virus ribonucleic acid (HIV RNA) change from baseline using observed values
Time Frame Baseline to Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug. n=participants with both baseline and time point results
Arm/Group Title Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 23 12 21 35 8
Mean (Standard Error)
Unit of Measure: Log copies per millileter
Week 24 Number Analyzed 23 participants 12 participants 21 participants 35 participants 8 participants
-2.10  (0.2863) -3.07  (0.4780) -2.69  (0.2257) -2.66  (0.1550) -2.24  (0.3821)
Week 48 Number Analyzed 23 participants 12 participants 21 participants 35 participants 1 participants
-2.31  (0.3174) -4.06  (0.1649) -2.91  (0.1883) -2.70  (0.1269) -3.97 [1]   (NA)
[1]
Only 1 participant in this arm was eligible for evaluation at this time point
7.Secondary Outcome
Title Mean Change From Baseline in CD4 Percent on ATV Powder
Hide Description Change in CD4 percent using observed values
Time Frame Baseline to Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with both baseline and time point results; n=number of participants evaluable at time point
Arm/Group Title Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 23 12 21 35 8
Mean (Standard Error)
Unit of Measure: Percent Change
Week 24 Number Analyzed 17 participants 4 participants 12 participants 23 participants 6 participants
5.1  (1.521) 4.0  (1.581) 5.4  (2.448) 6.3  (1.280) -0.3  (4.349)
Week 48 Number Analyzed 12 participants 0 participants 9 participants 19 participants 1 participants
2.8  (3.167) 8.9  (2.182) 7.5  (1.825) 1.0 [1]   (NA)
[1]
Only one participant was analyzed
8.Secondary Outcome
Title CD4 Cell Count Changes From Baseline on ATV Powder
Hide Description CD4 cell count change from baseline using observed values
Time Frame Baseline to Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with both baseline and time point results
Arm/Group Title Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 10 1 13 27 8
Mean (Standard Error)
Unit of Measure: Cells/mm^3
Week 24 Number Analyzed 10 participants 1 participants 13 participants 27 participants 8 participants
218.7  (259.102) 67.8  (425.659) 247.1  (110.739) 246.1  (72.044) 145.8  (78.443)
Week 48 Number Analyzed 10 participants 0 participants 13 participants 27 participants 1 participants
-409.8  (437.686) 400.0  (156.021) 335.4  (108.925) 213.0 [1]   (NA)
[1]
Only one participant was analyzed
9.Secondary Outcome
Title Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48
Hide Description 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
Time Frame Baseline through Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with virologic failure.
Arm/Group Title Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 10 2 10 13 1
Measure Type: Number
Unit of Measure: Participants
Any PI substitutions 4 0 4 3 0
Any IAS-USA PI substitutions 1 0 2 0 0
Any select RT substitutions 2 1 2 1 0
NRTI 1 1 2 1 0
10.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description 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
Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 12 17 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
5776.70  (3417.208) 5644.12  (3093.516) 4893.75  (2523.959)
11.Secondary Outcome
Title Minimum Plasma Concentration (Cmin)
Hide Description 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
Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 12 17 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
718.90  (432.747) 857.06  (599.221) 1030.64  (1070.932)
12.Secondary Outcome
Title Area Under the Concentration-Time Curve [AUC(TAU)]
Hide Description 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
Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 12 17 8
Mean (Standard Deviation)
Unit of Measure: ng.h./mL
49387.12  (26890.782) 59671.80  (31706.655) 56356.00  (35233.024)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title B/L Weight 5 to lt 10kg (ATV 150mg) B/L Weight 5 to lt 10kg (ATV 200mg) B/L Weight 10 to lt 15kg B/L Weight 15 to lt 25kg B/L Weight 25 to lt 35kg
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
B/L Weight 5 to lt 10kg (ATV 150mg) B/L Weight 5 to lt 10kg (ATV 200mg) B/L Weight 10 to lt 15kg B/L Weight 15 to lt 25kg B/L Weight 25 to lt 35kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/12 (0.00%)   0/21 (0.00%)   0/35 (0.00%)   0/8 (0.00%) 
Hide Serious Adverse Events
B/L Weight 5 to lt 10kg (ATV 150mg) B/L Weight 5 to lt 10kg (ATV 200mg) B/L Weight 10 to lt 15kg B/L Weight 15 to lt 25kg B/L Weight 25 to lt 35kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/23 (26.09%)   3/12 (25.00%)   8/21 (38.10%)   10/35 (28.57%)   0/8 (0.00%) 
Blood and lymphatic system disorders           
Lymphadenopathy  1  0/23 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  0/35 (0.00%)  0/8 (0.00%) 
Neutropenia  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  1/35 (2.86%)  0/8 (0.00%) 
Gastrointestinal disorders           
Pancreatitis acute  1  1/23 (4.35%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Vomiting  1  0/23 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  0/35 (0.00%)  0/8 (0.00%) 
Hepatobiliary disorders           
Hyperbilirubinaemia  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  1/35 (2.86%)  0/8 (0.00%) 
Immune system disorders           
Immune reconstitution inflammatory syndrome  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  1/35 (2.86%)  0/8 (0.00%) 
Infections and infestations           
Cellulitis  1  1/23 (4.35%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Dysentery  1  1/23 (4.35%)  0/12 (0.00%)  1/21 (4.76%)  0/35 (0.00%)  0/8 (0.00%) 
Gastroenteritis  1  1/23 (4.35%)  1/12 (8.33%)  1/21 (4.76%)  0/35 (0.00%)  0/8 (0.00%) 
Hepatitis a  1  1/23 (4.35%)  0/12 (0.00%)  0/21 (0.00%)  1/35 (2.86%)  0/8 (0.00%) 
Infective corneal ulcer  1  0/23 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  0/35 (0.00%)  0/8 (0.00%) 
Lower respiratory tract infection  1  1/23 (4.35%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Otitis media  1  0/23 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  0/35 (0.00%)  0/8 (0.00%) 
Pertussis  1  0/23 (0.00%)  1/12 (8.33%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Pulmonary tuberculosis  1  0/23 (0.00%)  1/12 (8.33%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Sinusitis  1  1/23 (4.35%)  0/12 (0.00%)  1/21 (4.76%)  0/35 (0.00%)  0/8 (0.00%) 
Tonsillitis  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  1/35 (2.86%)  0/8 (0.00%) 
Varicella  1  0/23 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  0/35 (0.00%)  0/8 (0.00%) 
Injury, poisoning and procedural complications           
Overdose  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  2/35 (5.71%)  0/8 (0.00%) 
Pneumonitis chemical  1  0/23 (0.00%)  1/12 (8.33%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Accidental exposure to product  1  1/23 (4.35%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Investigations           
Alanine aminotransferase increased  1  0/23 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  2/35 (5.71%)  0/8 (0.00%) 
Aspartate aminotransferase increased  1  0/23 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  0/35 (0.00%)  0/8 (0.00%) 
Blood bilirubin increased  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  1/35 (2.86%)  0/8 (0.00%) 
Transaminases increased  1  1/23 (4.35%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Reproductive system and breast disorders           
Varicocele  1  0/23 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  0/35 (0.00%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
B/L Weight 5 to lt 10kg (ATV 150mg) B/L Weight 5 to lt 10kg (ATV 200mg) B/L Weight 10 to lt 15kg B/L Weight 15 to lt 25kg B/L Weight 25 to lt 35kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/23 (95.65%)   10/12 (83.33%)   19/21 (90.48%)   31/35 (88.57%)   7/8 (87.50%) 
Blood and lymphatic system disorders           
Anaemia  1  8/23 (34.78%)  2/12 (16.67%)  0/21 (0.00%)  2/35 (5.71%)  0/8 (0.00%) 
Basophilia  1  0/23 (0.00%)  0/12 (0.00%)  2/21 (9.52%)  0/35 (0.00%)  0/8 (0.00%) 
Leukopenia  1  0/23 (0.00%)  0/12 (0.00%)  2/21 (9.52%)  0/35 (0.00%)  0/8 (0.00%) 
Lymphadenopathy  1  1/23 (4.35%)  1/12 (8.33%)  2/21 (9.52%)  5/35 (14.29%)  0/8 (0.00%) 
Neutropenia  1  1/23 (4.35%)  0/12 (0.00%)  2/21 (9.52%)  1/35 (2.86%)  0/8 (0.00%) 
Thrombocytopenia  1  2/23 (8.70%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Thrombocytosis  1  2/23 (8.70%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Congenital, familial and genetic disorders           
Dysmorphism  1  0/23 (0.00%)  1/12 (8.33%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Ear and labyrinth disorders           
Ear pain  1  0/23 (0.00%)  0/12 (0.00%)  2/21 (9.52%)  2/35 (5.71%)  0/8 (0.00%) 
Endocrine disorders           
Goitre  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  1/8 (12.50%) 
Eye disorders           
Conjunctivitis allergic  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  2/35 (5.71%)  1/8 (12.50%) 
Iritis  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  1/8 (12.50%) 
Myopia  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  1/8 (12.50%) 
Strabismus  1  0/23 (0.00%)  1/12 (8.33%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Gastrointestinal disorders           
Abdominal pain  1  0/23 (0.00%)  0/12 (0.00%)  2/21 (9.52%)  0/35 (0.00%)  0/8 (0.00%) 
Abdominal pain upper  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  1/35 (2.86%)  1/8 (12.50%) 
Dental caries  1  4/23 (17.39%)  1/12 (8.33%)  3/21 (14.29%)  4/35 (11.43%)  0/8 (0.00%) 
Diarrhoea  1  6/23 (26.09%)  0/12 (0.00%)  3/21 (14.29%)  3/35 (8.57%)  1/8 (12.50%) 
Dyspepsia  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  1/8 (12.50%) 
Nausea  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  1/35 (2.86%)  1/8 (12.50%) 
Toothache  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  3/35 (8.57%)  0/8 (0.00%) 
Vomiting  1  7/23 (30.43%)  1/12 (8.33%)  6/21 (28.57%)  9/35 (25.71%)  3/8 (37.50%) 
Constipation  1  0/23 (0.00%)  1/12 (8.33%)  1/21 (4.76%)  0/35 (0.00%)  0/8 (0.00%) 
General disorders           
Asthenia  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  2/8 (25.00%) 
Chest pain  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  1/8 (12.50%) 
Pyrexia  1  3/23 (13.04%)  0/12 (0.00%)  8/21 (38.10%)  4/35 (11.43%)  3/8 (37.50%) 
Hepatobiliary disorders           
Hyperbilirubinaemia  1  2/23 (8.70%)  0/12 (0.00%)  6/21 (28.57%)  2/35 (5.71%)  1/8 (12.50%) 
Jaundice  1  0/23 (0.00%)  0/12 (0.00%)  3/21 (14.29%)  3/35 (8.57%)  0/8 (0.00%) 
Ocular icterus  1  1/23 (4.35%)  0/12 (0.00%)  2/21 (9.52%)  1/35 (2.86%)  0/8 (0.00%) 
Infections and infestations           
Acarodermatitis  1  6/23 (26.09%)  0/12 (0.00%)  1/21 (4.76%)  3/35 (8.57%)  0/8 (0.00%) 
Body tinea  1  0/23 (0.00%)  3/12 (25.00%)  0/21 (0.00%)  2/35 (5.71%)  0/8 (0.00%) 
Bronchitis  1  2/23 (8.70%)  0/12 (0.00%)  2/21 (9.52%)  3/35 (8.57%)  0/8 (0.00%) 
Bronchitis bacterial  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  1/8 (12.50%) 
Candida nappy rash  1  8/23 (34.78%)  2/12 (16.67%)  1/21 (4.76%)  0/35 (0.00%)  0/8 (0.00%) 
Conjunctivitis  1  2/23 (8.70%)  0/12 (0.00%)  1/21 (4.76%)  4/35 (11.43%)  0/8 (0.00%) 
Ear infection  1  0/23 (0.00%)  0/12 (0.00%)  2/21 (9.52%)  2/35 (5.71%)  0/8 (0.00%) 
Fungal skin infection  1  1/23 (4.35%)  1/12 (8.33%)  0/21 (0.00%)  1/35 (2.86%)  0/8 (0.00%) 
Gastroenteritis  1  14/23 (60.87%)  3/12 (25.00%)  11/21 (52.38%)  8/35 (22.86%)  2/8 (25.00%) 
Helminthic infection  1  7/23 (30.43%)  2/12 (16.67%)  0/21 (0.00%)  1/35 (2.86%)  0/8 (0.00%) 
Impetigo  1  7/23 (30.43%)  0/12 (0.00%)  2/21 (9.52%)  2/35 (5.71%)  1/8 (12.50%) 
Influenza  1  1/23 (4.35%)  0/12 (0.00%)  2/21 (9.52%)  4/35 (11.43%)  1/8 (12.50%) 
Lower respiratory tract infection  1  7/23 (30.43%)  5/12 (41.67%)  1/21 (4.76%)  1/35 (2.86%)  1/8 (12.50%) 
Nasopharyngitis  1  2/23 (8.70%)  0/12 (0.00%)  8/21 (38.10%)  6/35 (17.14%)  0/8 (0.00%) 
Oral candidiasis  1  9/23 (39.13%)  4/12 (33.33%)  1/21 (4.76%)  0/35 (0.00%)  0/8 (0.00%) 
Oral herpes  1  2/23 (8.70%)  1/12 (8.33%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Otitis externa  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  1/8 (12.50%) 
Otitis media  1  6/23 (26.09%)  3/12 (25.00%)  0/21 (0.00%)  3/35 (8.57%)  1/8 (12.50%) 
Otitis media acute  1  7/23 (30.43%)  0/12 (0.00%)  0/21 (0.00%)  3/35 (8.57%)  1/8 (12.50%) 
Pharyngitis  1  2/23 (8.70%)  0/12 (0.00%)  6/21 (28.57%)  7/35 (20.00%)  1/8 (12.50%) 
Pharyngotonsillitis  1  1/23 (4.35%)  0/12 (0.00%)  1/21 (4.76%)  1/35 (2.86%)  1/8 (12.50%) 
Pneumonia  1  4/23 (17.39%)  1/12 (8.33%)  1/21 (4.76%)  2/35 (5.71%)  0/8 (0.00%) 
Pulmonary tuberculosis  1  2/23 (8.70%)  0/12 (0.00%)  1/21 (4.76%)  0/35 (0.00%)  0/8 (0.00%) 
Respiratory tract infection viral  1  0/23 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  2/35 (5.71%)  0/8 (0.00%) 
Sinusitis  1  0/23 (0.00%)  0/12 (0.00%)  2/21 (9.52%)  0/35 (0.00%)  0/8 (0.00%) 
Tinea capitis  1  7/23 (30.43%)  1/12 (8.33%)  3/21 (14.29%)  4/35 (11.43%)  0/8 (0.00%) 
Tonsillitis  1  3/23 (13.04%)  1/12 (8.33%)  1/21 (4.76%)  3/35 (8.57%)  1/8 (12.50%) 
Tooth abscess  1  0/23 (0.00%)  0/12 (0.00%)  2/21 (9.52%)  0/35 (0.00%)  0/8 (0.00%) 
Upper respiratory tract infection  1  16/23 (69.57%)  5/12 (41.67%)  5/21 (23.81%)  10/35 (28.57%)  2/8 (25.00%) 
Urinary tract infection  1  3/23 (13.04%)  1/12 (8.33%)  0/21 (0.00%)  2/35 (5.71%)  1/8 (12.50%) 
Varicella  1  0/23 (0.00%)  0/12 (0.00%)  2/21 (9.52%)  0/35 (0.00%)  0/8 (0.00%) 
Varicella zoster virus infection  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  1/8 (12.50%) 
Viral infection  1  0/23 (0.00%)  0/12 (0.00%)  2/21 (9.52%)  0/35 (0.00%)  0/8 (0.00%) 
Viral upper respiratory tract infection  1  3/23 (13.04%)  1/12 (8.33%)  2/21 (9.52%)  2/35 (5.71%)  0/8 (0.00%) 
Fungal infection  1  0/23 (0.00%)  1/12 (8.33%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Skin candida  1  0/23 (0.00%)  1/12 (8.33%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Skin infection  1  0/23 (0.00%)  1/12 (8.33%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Viral rash  1  0/23 (0.00%)  1/12 (8.33%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Injury, poisoning and procedural complications           
Arthropod bite  1  4/23 (17.39%)  0/12 (0.00%)  0/21 (0.00%)  1/35 (2.86%)  1/8 (12.50%) 
Foreign body in ear  1  1/23 (4.35%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  1/8 (12.50%) 
Overdose  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  1/8 (12.50%) 
Thermal burn  1  2/23 (8.70%)  0/12 (0.00%)  0/21 (0.00%)  1/35 (2.86%)  0/8 (0.00%) 
Investigations           
Alanine aminotransferase increased  1  2/23 (8.70%)  0/12 (0.00%)  0/21 (0.00%)  2/35 (5.71%)  0/8 (0.00%) 
Amylase increased  1  2/23 (8.70%)  1/12 (8.33%)  1/21 (4.76%)  0/35 (0.00%)  1/8 (12.50%) 
Blood alkaline phosphatase increased  1  2/23 (8.70%)  0/12 (0.00%)  1/21 (4.76%)  0/35 (0.00%)  0/8 (0.00%) 
Head lag  1  2/23 (8.70%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Lipase increased  1  1/23 (4.35%)  1/12 (8.33%)  1/21 (4.76%)  0/35 (0.00%)  0/8 (0.00%) 
Transaminases increased  1  2/23 (8.70%)  0/12 (0.00%)  1/21 (4.76%)  1/35 (2.86%)  0/8 (0.00%) 
Weight decreased  1  1/23 (4.35%)  2/12 (16.67%)  0/21 (0.00%)  1/35 (2.86%)  1/8 (12.50%) 
Metabolism and nutrition disorders           
Decreased appetite  1  1/23 (4.35%)  1/12 (8.33%)  1/21 (4.76%)  2/35 (5.71%)  1/8 (12.50%) 
Hypercholesterolaemia  1  0/23 (0.00%)  0/12 (0.00%)  5/21 (23.81%)  0/35 (0.00%)  0/8 (0.00%) 
Hypertriglyceridaemia  1  0/23 (0.00%)  0/12 (0.00%)  2/21 (9.52%)  0/35 (0.00%)  0/8 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Skin papilloma  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  2/35 (5.71%)  0/8 (0.00%) 
Nervous system disorders           
Headache  1  0/23 (0.00%)  0/12 (0.00%)  2/21 (9.52%)  3/35 (8.57%)  2/8 (25.00%) 
Lethargy  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  2/35 (5.71%)  0/8 (0.00%) 
Product Issues           
Product taste abnormal  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  1/8 (12.50%) 
Psychiatric disorders           
Pica  1  2/23 (8.70%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Renal and urinary disorders           
Haematuria  1  1/23 (4.35%)  1/12 (8.33%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Proteinuria  1  2/23 (8.70%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Asthma  1  0/23 (0.00%)  0/12 (0.00%)  4/21 (19.05%)  1/35 (2.86%)  0/8 (0.00%) 
Cough  1  3/23 (13.04%)  2/12 (16.67%)  0/21 (0.00%)  10/35 (28.57%)  2/8 (25.00%) 
Nasal congestion  1  5/23 (21.74%)  4/12 (33.33%)  0/21 (0.00%)  4/35 (11.43%)  0/8 (0.00%) 
Obstructive airways disorder  1  1/23 (4.35%)  1/12 (8.33%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Oropharyngeal pain  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  1/8 (12.50%) 
Rhinitis allergic  1  0/23 (0.00%)  1/12 (8.33%)  3/21 (14.29%)  1/35 (2.86%)  0/8 (0.00%) 
Rhinorrhoea  1  5/23 (21.74%)  0/12 (0.00%)  2/21 (9.52%)  3/35 (8.57%)  1/8 (12.50%) 
Skin and subcutaneous tissue disorders           
Dermatitis  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  2/35 (5.71%)  0/8 (0.00%) 
Dermatitis allergic  1  2/23 (8.70%)  0/12 (0.00%)  0/21 (0.00%)  1/35 (2.86%)  1/8 (12.50%) 
Dermatitis atopic  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  1/35 (2.86%)  2/8 (25.00%) 
Dermatitis diaper  1  5/23 (21.74%)  3/12 (25.00%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Dry skin  1  1/23 (4.35%)  0/12 (0.00%)  0/21 (0.00%)  2/35 (5.71%)  0/8 (0.00%) 
Eczema  1  5/23 (21.74%)  2/12 (16.67%)  2/21 (9.52%)  3/35 (8.57%)  0/8 (0.00%) 
Rash  1  0/23 (0.00%)  0/12 (0.00%)  2/21 (9.52%)  2/35 (5.71%)  0/8 (0.00%) 
Seborrhoeic dermatitis  1  3/23 (13.04%)  1/12 (8.33%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
Urticaria  1  0/23 (0.00%)  0/12 (0.00%)  1/21 (4.76%)  0/35 (0.00%)  1/8 (12.50%) 
Urticaria chronic  1  0/23 (0.00%)  0/12 (0.00%)  0/21 (0.00%)  0/35 (0.00%)  1/8 (12.50%) 
Dermatitis contact  1  0/23 (0.00%)  1/12 (8.33%)  0/21 (0.00%)  1/35 (2.86%)  0/8 (0.00%) 
Miliaria  1  0/23 (0.00%)  1/12 (8.33%)  0/21 (0.00%)  0/35 (0.00%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01335698    
Other Study ID Numbers: AI424-451
2010-024537-23 ( EudraCT Number )
First Submitted: April 13, 2011
First Posted: April 14, 2011
Results First Submitted: October 26, 2015
Results First Posted: February 8, 2016
Last Update Posted: November 9, 2018