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PRINCE: Study of Atazanavir (ATV)/Ritonavir (RTV) (PRINCE1)

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ClinicalTrials.gov Identifier: NCT01099579
Recruitment Status : Completed
First Posted : April 7, 2010
Results First Posted : February 6, 2014
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Atazanavir powder
Drug: Ritonavir oral solution
Drug: Atazanavir capsules
Drug: Ritonavir capsules
Enrollment 82
Recruitment Details  
Pre-assignment Details A total of 82 pediatric patients were enrolled, and 56 received treatment. Reasons for not receiving treatment treated were: no longer met study criteria (23 patients), other reason (2 patients), and withdrew consent (1 patient).
Arm/Group Title Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Hide Arm/Group Description Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg. Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg. Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
Period Title: Stage 1 (ATV Powder Formulation)
Started 21 19 16
Completed 17 [1] 14 [1] 15 [1]
Not Completed 4 5 1
Reason Not Completed
Adverse Event             4             1             0
Withdrawal by Subject             0             0             1
Lack of Efficacy             0             2             0
Poor compliance/noncompliance             0             2             0
[1]
Completed Stage 1
Period Title: Stage 2 (ATV Capsule)
Started 16 14 15
Completed 10 9 9
Not Completed 6 5 6
Reason Not Completed
No longer met study criteria             2             2             1
Lost to Follow-up             1             1             1
Lack of Efficacy             0             0             2
Withdrawal by Subject             1             1             1
Poor/Non-Compliance             2             0             1
Adverse Event             0             1             0
Arm/Group Title Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg Total
Hide Arm/Group Description Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. RTV capsules or tablets were ingested with food immediately before or after ATV intake. Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to 20 kg received ATV, 150 mg, with RTV, 100 mg, and those who weighed 20 to 40 mg received ATV, 200 mg with RTV,100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake. Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 20 to 40 mg received ATV, 200 mg, with RTV, 100 mg, and those who weighed at least 40 kg received ATV, 300 mg, with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake. Total of all reporting groups
Overall Number of Baseline Participants 21 19 16 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 21 participants 19 participants 16 participants 56 participants
7.3  (4.05) 35.4  (11.63) 52.1  (10.49) 29.6  (20.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 16 participants 56 participants
Female
10
  47.6%
12
  63.2%
6
  37.5%
28
  50.0%
Male
11
  52.4%
7
  36.8%
10
  62.5%
28
  50.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 16 participants 56 participants
Not Hispanic or Latino
0
   0.0%
0
   0.0%
1
   6.3%
1
   1.8%
Not reported
21
 100.0%
19
 100.0%
15
  93.8%
55
  98.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 16 participants 56 participants
White
2
   9.5%
3
  15.8%
6
  37.5%
11
  19.6%
Black/African American
13
  61.9%
12
  63.2%
7
  43.8%
32
  57.1%
Asian
0
   0.0%
1
   5.3%
0
   0.0%
1
   1.8%
Other
6
  28.6%
3
  15.8%
3
  18.8%
12
  21.4%
Country  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 16 participants 56 participants
Chile
1
   4.8%
2
  10.5%
3
  18.8%
6
  10.7%
Mexico
2
   9.5%
3
  15.8%
4
  25.0%
9
  16.1%
Peru
1
   4.8%
0
   0.0%
1
   6.3%
2
   3.6%
South Africa
17
  81.0%
13
  68.4%
8
  50.0%
38
  67.9%
Thailand
0
   0.0%
1
   5.3%
0
   0.0%
1
   1.8%
HIV RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 c/mL
Number Analyzed 21 participants 19 participants 16 participants 56 participants
4.77  (0.602) 4.83  (0.268) 4.18  (0.727) 4.62  (0.617)
HIV RNA  
Measure Type: Number
Unit of measure:  c/mL
Number Analyzed 21 participants 19 participants 16 participants 56 participants
<30,000 c/mL 3 2 9 14
30,000 to 100,000 c/mL 0 7 3 10
>100,000 c/mL 18 10 4 32
CD4 Count  
Mean (Standard Deviation)
Unit of measure:  Cells/mm^3
Number Analyzed 21 participants 19 participants 16 participants 56 participants
1594.1  (897.19) 1107.4  (643.25) 661.1  (302.60) 1192.6  (784.08)
CD4 Percent  
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 21 participants 19 participants 16 participants 56 participants
25.4  (12.11) 22.0  (9.35) 27.5  (9.85) 24.8  (10.61)
CD4 Percent  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 16 participants 56 participants
<15
2
   9.5%
2
  10.5%
1
   6.3%
5
   8.9%
15 to <25
7
  33.3%
6
  31.6%
4
  25.0%
17
  30.4%
>=25
7
  33.3%
6
  31.6%
6
  37.5%
19
  33.9%
Not reported
5
  23.8%
5
  26.3%
5
  31.3%
15
  26.8%
Prior Antiretroviral (ARV) Treatment Use   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 16 participants 56 participants
ARV naive
7
  33.3%
10
  52.6%
5
  31.3%
22
  39.3%
ARV experienced
14
  66.7%
9
  47.4%
11
  68.8%
34
  60.7%
[1]
Measure Description: ATV naive is defined as without prior exposure to ARV treatment; ARV experienced is defined as previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines. Patients exposed to ARVs in utero or intrapartum were permitted in the study but were considered treatment naive.
1.Primary Outcome
Title Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation
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. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Time Frame From Day 1 to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of active atazanavir powder.
Arm/Group Title Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Hide Arm/Group Description:
Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Overall Number of Participants Analyzed 21 19 16
Measure Type: Number
Unit of Measure: Participants
Deaths 0 0 0
SAEs 5 2 4
AEs leading to discontinuation 4 1 0
2.Primary Outcome
Title Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4
Hide Description ALT=alanine aminotransferase; SGPT=serum glutamic-pyruvic transaminase; AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase; ULN=upper limit of normal. Grading by the National Institute of Health Division of AIDs and World Health Organization criteria. Hemoglobin (g/dL): Grade (Gr)1=9.5-11.0; Gr 2=8.0-9.4; Gr 3=6.5-7.9; Gr 4=<6.5. Neutrophils, absolute (/mm^3): Gr 1=>=1000-<1500; Gr 2= >=750-<1000; Gr 3=>=500-<750; Gr 4=<500. ALT/SGPT (*ULN): Gr 1=1.25-2.5; Gr 2=2.6–5; Gr 3=5.1-10; Gr 4=>10. AST/SGOT (*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5; Gr 3=5.1-10; Gr 4=>10. Alkaline phosphatase(*ULN): Gr 1=1.25-2.5; Gr 2=2.6–5: Gr 3=5.1-10; Gr 4=>10. Total bilirubin (*ULN): Gr 1=1.1-1; Gr 2=1.6-2.5; Gr 3=2.6-5; Gr 4=>5. Amylase (*ULN): Gr 1=1.10-39; Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=>5.0. Lipase (*ULN): Gr 1=1.10-1.39: Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=>5.0. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12.0; Gr 3=12.1-15.0; Gr 4=>15.
Time Frame After Day 1 to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of atazanavir; n=number of evaluable participants.
Arm/Group Title Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Hide Arm/Group Description:
Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Overall Number of Participants Analyzed 21 19 16
Measure Type: Number
Unit of Measure: Participants
Hemoglobin (n=20, 17, 15) 2 3 0
Neutrophils, absolute (n=20, 17, 15) 3 2 0
ALT/SGPT (n=20, 18, 15) 5 0 1
AST/SGOT (n=20, 18, 15) 1 0 0
Alkaline phosphatase (n=20, 18, 15) 0 1 0
Total bilirubin (n=20, 18, 15) 2 0 3
Amylase (n=20, 18, 15) 8 5 1
Lipase (n=20, 18, 15) 0 1 1
Uric acid n=20, 18, 15) 0 0 1
3.Primary Outcome
Title Electrocardiogram Changes From Baseline in PR Interval, QTC Bazett, and QTC Fridericia at Week 48
Hide Description Electrocardiogram parameters were measured at baseline for QTC Bazett, QTC Fridericia, and PR interval. The mean change from baseline at week 48 is reported by arm in milliseconds.
Time Frame From Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of atazanavir and were evaluable
Arm/Group Title Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Hide Arm/Group Description:
Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Overall Number of Participants Analyzed 17 15 13
Mean (Standard Deviation)
Unit of Measure: Milliseconds
PR Interval 4.9  (21.80) 12.0  (8.04) 6.2  (8.54)
QTC Bazett 1.7  (17.73) -3.2  (21.78) -4.2  (13.02)
QTC Fridericia 7.9  (18.36) 13.2  (18.92) 4.8  (11.49)
4.Primary Outcome
Title Number of Participants With Centers for Disease Control (CDC) Class C AIDS Events
Hide Description CDC Class C events are AIDS-defining events that include recurrent bacterial pneumonia (>=2 episodes in 12 months); candidiasis of the bronchi, trachea, lungs, or esophagus; invasive cervical carcinoma; disseminated or extrapulmonary coccidioidomycosis; extrapulmonary cryptococcosis; chronic intestinal cryptosporidiosis (>1 month); cytomegalovirus disease; HIV-related encephalopathy; herpes simplex: chronic ulcers, or bronchitis, pneumonitis, or esophagitis; disseminated or extrapulmonary histoplasmosis; chronic intestinal isosporiasis; Kaposi sarcoma; immunoblastic or primary brain Burkitt lymphoma; mycobacterium avium complex, kansasii, or tuberculosis; mycobacterium, other species; Pneumocystis carinii pneumonia; progressive multifocal leukoencephalopathy; Salmonella septicemia; recurrent toxoplasmosis of brain; HIV wasting syndrome (involuntary weight loss >10% of baseline body weight) with chronic diarrhea or chronic weakness and documented fever for ≥1 month.
Time Frame From Day 1 to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Hide Arm/Group Description:
Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Overall Number of Participants Analyzed 21 19 16
Measure Type: Number
Unit of Measure: Participants
1 1 0
5.Secondary Outcome
Title Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Treatment/Weight
Hide Description The definition of virologic success included HIV RNA levels <50 c/mL or 400 c/mL at the Week 48 analysis window. .
Time Frame At Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of atazanavir and who did not switch to the capsule formulation at or before Week 48
Arm/Group Title Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Hide Arm/Group Description:
Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Overall Number of Participants Analyzed 21 19 14
Measure Type: Number
Unit of Measure: Percentage of participants
HIV RNA levels <50 c/mL 47.6 68.4 71.4
HIV RNA levels <400 c/mL 66.7 73.7 85.7
6.Secondary Outcome
Title Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Prior Antiretroviral (ARV) Treatment Status
Hide Description The definition of virologic success included HIV RNA levels <50 c/mL or <400 c/mL at the Week 48 analysis.
Time Frame From Day 1 to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of atazanavir (ATV) and who did not switch to the ATV capsule formulation on or before Week 48
Arm/Group Title ARV-experienced ARV-naive
Hide Arm/Group Description:
ARV-experienced participants had previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
ARV-naive participants had no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
Overall Number of Participants Analyzed 20 34
Measure Type: Number
Unit of Measure: Percentage of participants
HIV RNA levels <50 c/mL 56.3 68.2
HIV RNA levels <400 c/mL 65.6 86.4
7.Secondary Outcome
Title Mean Change From Baseline in HIV RNA Levels at Week 48 by Treatment/Weight
Hide Description Participants who received at least 1 dose of atazanavir (ATV) and had an HIV RNA measurement on ATV powder at did not switch to the capsule formulation before Week 48
Time Frame From Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of atazanavir and who had HIV RNA while taking atazanavir powder at Week 48
Arm/Group Title Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Hide Arm/Group Description:
Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Overall Number of Participants Analyzed 17 15 13
Mean (Standard Error)
Unit of Measure: Log10 c/mL
-2.61  (0.3111) -2.93  (0.1678) -2.40  (0.2412)
8.Secondary Outcome
Title Mean Change From Baseline in HIV RNA Levels at Week 48 by Prior Antiretroviral (ARV) Treatment Status
Hide Description [Not Specified]
Time Frame From Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of atazanavir (ATV) and who had an HIV RNA measurement on ATV powder at Week 48
Arm/Group Title ARV-experienced ARV-naive
Hide Arm/Group Description:
ARV-experienced participants had previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
ARV-naive participants had no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
Overall Number of Participants Analyzed 34 22
Mean (Standard Error)
Unit of Measure: Log10 c/mL
-2.53  (0.2452) -2.81  (0.1296)
9.Secondary Outcome
Title CD4 Cell Count Changes From Baseline at Week 48 by Treatment/Weight
Hide Description [Not Specified]
Time Frame From Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 at baseline and Week 48 while taking ATV powder
Arm/Group Title Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Hide Arm/Group Description:
Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Overall Number of Participants Analyzed 13 11 5
Mean (Standard Error)
Unit of Measure: Cells/mm^3
550.1  (285.24) 225.3  (198.34) 373.8  (68.83)
10.Secondary Outcome
Title CD4 Cell Count Changes From Baseline at Week 48 by Prior Antiretroviral (ARV) Treatment Status
Hide Description [Not Specified]
Time Frame From Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 at baseline and Week 48 while taking ATV powder
Arm/Group Title ARV-experienced ARV-naive
Hide Arm/Group Description:
ARV-experienced participants had previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
ARV-naive participants had no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
Overall Number of Participants Analyzed 34 22
Mean (Standard Error)
Unit of Measure: Cells/mm^3
437.9  (253.123) 352.1  (152.600)
11.Secondary Outcome
Title Mean CD4 Percent Changes From Baseline at Week 48 by Treatment/Weight
Hide Description [Not Specified]
Time Frame From Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 percent at baseline and Week 48 while taking ATV powder
Arm/Group Title Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Hide Arm/Group Description:
Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Overall Number of Participants Analyzed 14 12 6
Mean (Standard Error)
Unit of Measure: Percentage of lymphocytes
6.1  (1.56) 7.3  (2.26) 8.8  (1.14)
12.Secondary Outcome
Title Mean CD4 Percent Changes From Baseline at Week 48 by Antiretroviral (ARV) Treatment Status
Hide Description [Not Specified]
Time Frame From Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 percent at baseline and Week 48 while taking ATV powder
Arm/Group Title ARV-experienced ARV-naive
Hide Arm/Group Description:
ARV-experienced participants had previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
ARV-naive participants had no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
Overall Number of Participants Analyzed 34 22
Mean (Standard Error)
Unit of Measure: Percentage of lymphocytes
4.3  (1.316) 9.8  (1.496)
13.Secondary Outcome
Title Number of Participants Who Acquired Phenotypic Resistance to Atazanavir or Atazanovir/Ritonavir
Hide Description Criteria for resistance testing= meeting at least 1 of the following: <1 log10 drop from baseline in HIV RNA level by Week 16 and confirmed by a second HIV RNA level; an HIV RNA level >200 copies/mL after Week 24, confirmed by a second HIV RNA level; repeated HIV RNA levels ≥50 copies/mL after Week 48; an HIV RNA level ≥400 copies/mL confirmed by a second HIV RNA level of ≥400 copies/mL at any time in a participant who had previously achieved a plasma HIV RNA level <50 copies/mL; or discontinued due to lack of efficacy. Virologic failure was defined as an incomplete virologic response to therapy or as a viral rebound after the achievement of virologic suppression. The phenotypic resistance to a drug is defined as a fold change (ie, ratio of the 50% inhibitory concentration [IC50] of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility.
Time Frame After Day 1 to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who met the criteria for virologic failure
Arm/Group Title ARV-experienced ARV-naive
Hide Arm/Group Description:
ARV-experienced participants had previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
ARV-naive participants had no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
Overall Number of Participants Analyzed 6 8
Measure Type: Number
Unit of Measure: Participants
Atazanavir 0 0
Ritonavir 0 0
14.Secondary Outcome
Title Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Atazanavir and Ritonavir
Hide Description [Not Specified]
Time Frame At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)
Arm/Group Title Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Hide Arm/Group Description:
Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Overall Number of Participants Analyzed 20 18 15
Geometric Mean (Full Range)
Unit of Measure: ng/mL
Atazanavir Cmax
4131
(1110 to 9660)
5197
(390 to 15000)
6172
(3560 to 10400)
Atazanavir Cmin
336
(11.4 to 1330)
572
(11.2 to 4870)
698
(238 to 2410)
Ritonavir Cmax (n=19, 18, 15)
2919
(188 to 9160)
2634
(163 to 17700)
1838
(582 to 4960)
Ritonavir Cmin (n=18, 16, 15)
41.8
(12.7 to 311)
143
(14.2 to 1610)
51.0
(9.0 to 468)
15.Secondary Outcome
Title Area Under the Concentration Curve (in 1 Dosing Interval From Time 0 to 24 Hours Post Observed Dose) (AUC[TAU])of Atazanavir and Ritonavir
Hide Description [Not Specified]
Time Frame At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)
Arm/Group Title Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Hide Arm/Group Description:
Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Overall Number of Participants Analyzed 20 18 15
Geometric Mean (Full Range)
Unit of Measure: ng*h/mL
AUC(TAU) Atazanavir
32503
(10441 to 94352)
50305
(6697 to 189971)
61485
(31599 to 117171)
AUC(TAU) Ritonavir (n=19, 18, 15)
17439
(1322 to 56864)
20510
(971 to 229777)
13640
(3376 to 40806)
16.Secondary Outcome
Title Time to Maximum Observed Concentration (Tmax) of Atazanavir and Ritonavir
Hide Description [Not Specified]
Time Frame At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)
Arm/Group Title Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Hide Arm/Group Description:
Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Overall Number of Participants Analyzed 20 18 15
Median (Full Range)
Unit of Measure: Hours
Tmax Atazanavir
1.58
(1.40 to 12.0)
1.97
(1.00 to 6.00)
4.0
(1.5 to 6.0)
Tmax Ritonavir
1.8
(1.3 to 11.9)
2.9
(1.0 to 8.0)
4.0
(1.5 to 6.0)
17.Secondary Outcome
Title Apparent Total Body Clearance (CLT/F) of Atazanavir and Ritonavir
Hide Description Calculated as dose divided by AUC(TAU). AUC(TAU)=area under the concentration-time curve in 1 dosing interval from time 0 to 24 hours post observed dose.
Time Frame At Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)
Arm/Group Title Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Hide Arm/Group Description:
Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Overall Number of Participants Analyzed 20 18 15
Geometric Mean (Full Range)
Unit of Measure: L/h
CLT/F Atazanavir
4.61
(1.6 to 14.4)
3.98
(1.1 to 29.9)
4.07
(2.1 to 7.9)
CLT/F Ritonavir (n=19, 18, 15
4.59
(1.4 to 60.5)
3.90
(0.3 to 82.4)
5.87
(2.0 to 23.7)
18.Secondary Outcome
Title Apparent Total Body Clearance Per Body Weight (CLT/F) Per Kilogram of Atazanavir and Ritonavir
Hide Description Calculated as CLT/F divided by body weight
Time Frame At Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)
Arm/Group Title Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg
Hide Arm/Group Description:
Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
Overall Number of Participants Analyzed 20 18 15
Geometric Mean (Full Range)
Unit of Measure: L/h per kilogram
CLT/F per kilogram Atazanavir
0.65
(0.2 to 1.8)
0.32
(0.1 to 2.6)
0.24
(0.1 to 0.5)
CLT/F per kilogram Ritonavir (n=19, 18, 15)
0.65
(0.2 to 7.5)
0.32
(0.04 to 5.9)
0.35
(0.1 to 1.4)
Time Frame From Day 1 to Week 48
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title B/L Weight 5 to Less Than 10 kg B/L Weight 10 to Less Than 15 kg B/L Weight 15 to Less Than 25 kg
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
B/L Weight 5 to Less Than 10 kg B/L Weight 10 to Less Than 15 kg B/L Weight 15 to Less Than 25 kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/19 (0.00%)   0/16 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
B/L Weight 5 to Less Than 10 kg B/L Weight 10 to Less Than 15 kg B/L Weight 15 to Less Than 25 kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/21 (33.33%)   5/19 (26.32%)   5/16 (31.25%) 
Blood and lymphatic system disorders       
Neutropenia  1  1/21 (4.76%)  0/19 (0.00%)  1/16 (6.25%) 
Thrombocytopenia  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Hepatobiliary disorders       
Drug-induced liver injury  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Infections and infestations       
Dengue fever  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Gastroenteritis  1  1/21 (4.76%)  0/19 (0.00%)  0/16 (0.00%) 
Herpes zoster disseminated  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Influenza  1  1/21 (4.76%)  0/19 (0.00%)  0/16 (0.00%) 
Lymphadenitis bacterial  1  1/21 (4.76%)  0/19 (0.00%)  0/16 (0.00%) 
Meningitis  1  1/21 (4.76%)  0/19 (0.00%)  1/16 (6.25%) 
Otitis media chronic  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Pneumonia  1  2/21 (9.52%)  0/19 (0.00%)  0/16 (0.00%) 
Sepsis  1  1/21 (4.76%)  0/19 (0.00%)  0/16 (0.00%) 
Varicella zoster virus infection  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Injury, poisoning and procedural complications       
Humerus fracture  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Investigations       
Electrocardiogram qt prolonged  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Transaminases increased  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Nervous system disorders       
Febrile convulsion  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Seizure  1  1/21 (4.76%)  0/19 (0.00%)  0/16 (0.00%) 
Psychiatric disorders       
Suicide attempt  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Respiratory, thoracic and mediastinal disorders       
Bronchiectasis  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
B/L Weight 5 to Less Than 10 kg B/L Weight 10 to Less Than 15 kg B/L Weight 15 to Less Than 25 kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/21 (100.00%)   18/19 (94.74%)   15/16 (93.75%) 
Blood and lymphatic system disorders       
Anaemia  1  1/21 (4.76%)  2/19 (10.53%)  0/16 (0.00%) 
Basophilia  1  1/21 (4.76%)  1/19 (5.26%)  1/16 (6.25%) 
Basophilopenia  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Eosinophilia  1  1/21 (4.76%)  2/19 (10.53%)  2/16 (12.50%) 
Leukopenia  1  0/21 (0.00%)  1/19 (5.26%)  1/16 (6.25%) 
Lymphadenitis  1  2/21 (9.52%)  0/19 (0.00%)  0/16 (0.00%) 
Lymphadenopathy  1  4/21 (19.05%)  4/19 (21.05%)  0/16 (0.00%) 
Lymphocytosis  1  1/21 (4.76%)  1/19 (5.26%)  1/16 (6.25%) 
Lymphopenia  1  0/21 (0.00%)  1/19 (5.26%)  1/16 (6.25%) 
Monocytopenia  1  0/21 (0.00%)  1/19 (5.26%)  1/16 (6.25%) 
Monocytosis  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Neutropenia  1  1/21 (4.76%)  1/19 (5.26%)  1/16 (6.25%) 
Splenomegaly  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Cardiac disorders       
Atrioventricular block first degree  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Ear and labyrinth disorders       
Cerumen impaction  1  0/21 (0.00%)  0/19 (0.00%)  3/16 (18.75%) 
Ear pain  1  0/21 (0.00%)  1/19 (5.26%)  3/16 (18.75%) 
Excessive cerumen production  1  1/21 (4.76%)  1/19 (5.26%)  0/16 (0.00%) 
Otorrhoea  1  0/21 (0.00%)  0/19 (0.00%)  2/16 (12.50%) 
Tympanic membrane perforation  1  1/21 (4.76%)  1/19 (5.26%)  1/16 (6.25%) 
Eye disorders       
Conjunctival hyperaemia  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Conjunctivitis allergic  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Eye pruritus  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Gastrointestinal disorders       
Abdominal distension  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Abdominal pain  1  0/21 (0.00%)  1/19 (5.26%)  2/16 (12.50%) 
Abdominal pain upper  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Anal pruritus  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Dental caries  1  4/21 (19.05%)  3/19 (15.79%)  3/16 (18.75%) 
Diarrhoea  1  11/21 (52.38%)  6/19 (31.58%)  7/16 (43.75%) 
Gastritis  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Oral mucosal blistering  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Tongue geographic  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Toothache  1  1/21 (4.76%)  2/19 (10.53%)  2/16 (12.50%) 
Vomiting  1  9/21 (42.86%)  8/19 (42.11%)  4/16 (25.00%) 
General disorders       
Asthenia  1  0/21 (0.00%)  0/19 (0.00%)  2/16 (12.50%) 
Local swelling  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Pyrexia  1  3/21 (14.29%)  7/19 (36.84%)  5/16 (31.25%) 
Hepatobiliary disorders       
Hepatomegaly  1  4/21 (19.05%)  1/19 (5.26%)  0/16 (0.00%) 
Hyperbilirubinaemia  1  1/21 (4.76%)  2/19 (10.53%)  4/16 (25.00%) 
Jaundice  1  1/21 (4.76%)  3/19 (15.79%)  2/16 (12.50%) 
Ocular icterus  1  2/21 (9.52%)  1/19 (5.26%)  1/16 (6.25%) 
Infections and infestations       
Acarodermatitis  1  6/21 (28.57%)  0/19 (0.00%)  1/16 (6.25%) 
Bacteriuria  1  1/21 (4.76%)  1/19 (5.26%)  1/16 (6.25%) 
Bronchitis  1  2/21 (9.52%)  4/19 (21.05%)  2/16 (12.50%) 
Candida nappy rash  1  5/21 (23.81%)  0/19 (0.00%)  0/16 (0.00%) 
Conjunctivitis  1  2/21 (9.52%)  2/19 (10.53%)  1/16 (6.25%) 
Ear infection  1  1/21 (4.76%)  1/19 (5.26%)  0/16 (0.00%) 
Enterobiasis  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Folliculitis  1  1/21 (4.76%)  0/19 (0.00%)  1/16 (6.25%) 
Fungal infection  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Fungal skin infection  1  2/21 (9.52%)  1/19 (5.26%)  0/16 (0.00%) 
Gastroenteritis  1  9/21 (42.86%)  5/19 (26.32%)  2/16 (12.50%) 
Helminthic infection  1  5/21 (23.81%)  2/19 (10.53%)  1/16 (6.25%) 
Herpes simplex  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Hordeolum  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Impetigo  1  4/21 (19.05%)  2/19 (10.53%)  2/16 (12.50%) 
Influenza  1  3/21 (14.29%)  1/19 (5.26%)  2/16 (12.50%) 
Lice infestation  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Lower respiratory tract infection  1  2/21 (9.52%)  3/19 (15.79%)  1/16 (6.25%) 
Lower respiratory tract infection viral  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Molluscum contagiosum  1  0/21 (0.00%)  1/19 (5.26%)  1/16 (6.25%) 
Nasopharyngitis  1  3/21 (14.29%)  1/19 (5.26%)  5/16 (31.25%) 
Oral candidiasis  1  9/21 (42.86%)  0/19 (0.00%)  0/16 (0.00%) 
Oral herpes  1  0/21 (0.00%)  1/19 (5.26%)  2/16 (12.50%) 
Otitis externa  1  3/21 (14.29%)  3/19 (15.79%)  1/16 (6.25%) 
Otitis media  1  8/21 (38.10%)  4/19 (21.05%)  4/16 (25.00%) 
Otitis media acute  1  3/21 (14.29%)  2/19 (10.53%)  2/16 (12.50%) 
Otitis media chronic  1  3/21 (14.29%)  1/19 (5.26%)  2/16 (12.50%) 
Parasitic gastroenteritis  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Pharyngitis  1  5/21 (23.81%)  4/19 (21.05%)  4/16 (25.00%) 
Pharyngotonsillitis  1  1/21 (4.76%)  0/19 (0.00%)  2/16 (12.50%) 
Pneumonia  1  4/21 (19.05%)  2/19 (10.53%)  0/16 (0.00%) 
Pulmonary tuberculosis  1  2/21 (9.52%)  0/19 (0.00%)  0/16 (0.00%) 
Respiratory tract infection  1  1/21 (4.76%)  1/19 (5.26%)  2/16 (12.50%) 
Rhinitis  1  1/21 (4.76%)  1/19 (5.26%)  2/16 (12.50%) 
Sinusitis  1  0/21 (0.00%)  0/19 (0.00%)  2/16 (12.50%) 
Skin infection  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Tinea capitis  1  4/21 (19.05%)  2/19 (10.53%)  2/16 (12.50%) 
Tinea faciei  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Tinea infection  1  1/21 (4.76%)  1/19 (5.26%)  3/16 (18.75%) 
Tonsillitis  1  7/21 (33.33%)  2/19 (10.53%)  1/16 (6.25%) 
Tooth abscess  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Upper respiratory tract infection  1  11/21 (52.38%)  6/19 (31.58%)  5/16 (31.25%) 
Urinary tract infection  1  6/21 (28.57%)  2/19 (10.53%)  0/16 (0.00%) 
Varicella  1  2/21 (9.52%)  1/19 (5.26%)  1/16 (6.25%) 
Viral rash  1  1/21 (4.76%)  0/19 (0.00%)  1/16 (6.25%) 
Viral upper respiratory tract infection  1  4/21 (19.05%)  8/19 (42.11%)  4/16 (25.00%) 
Vulvovaginal candidiasis  1  1/21 (4.76%)  1/19 (5.26%)  0/16 (0.00%) 
Injury, poisoning and procedural complications       
Animal bite  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Arthropod bite  1  5/21 (23.81%)  0/19 (0.00%)  1/16 (6.25%) 
Burns first degree  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Contusion  1  1/21 (4.76%)  1/19 (5.26%)  0/16 (0.00%) 
Foreign body  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Limb injury  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Overdose  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Scar  1  1/21 (4.76%)  2/19 (10.53%)  1/16 (6.25%) 
Skin abrasion  1  0/21 (0.00%)  1/19 (5.26%)  1/16 (6.25%) 
Upper limb fracture  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Investigations       
Alanine aminotransferase increased  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Amylase increased  1  2/21 (9.52%)  0/19 (0.00%)  1/16 (6.25%) 
Blood bilirubin increased  1  1/21 (4.76%)  0/19 (0.00%)  1/16 (6.25%) 
Blood sodium increased  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Body temperature increased  1  1/21 (4.76%)  0/19 (0.00%)  1/16 (6.25%) 
Cardiac murmur  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Crystal urine present  1  0/21 (0.00%)  1/19 (5.26%)  1/16 (6.25%) 
Electrocardiogram abnormal  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Lipase increased  1  2/21 (9.52%)  1/19 (5.26%)  0/16 (0.00%) 
Urinary sediment present  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Weight decreased  1  4/21 (19.05%)  3/19 (15.79%)  1/16 (6.25%) 
Metabolism and nutrition disorders       
Decreased appetite  1  5/21 (23.81%)  3/19 (15.79%)  2/16 (12.50%) 
Hyperamylasaemia  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Hypercholesterolaemia  1  1/21 (4.76%)  0/19 (0.00%)  1/16 (6.25%) 
Hyperlipasaemia  1  1/21 (4.76%)  1/19 (5.26%)  0/16 (0.00%) 
Hypertriglyceridaemia  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Back pain  1  1/21 (4.76%)  0/19 (0.00%)  1/16 (6.25%) 
Joint swelling  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Tendonitis  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Skin papilloma  1  0/21 (0.00%)  0/19 (0.00%)  2/16 (12.50%) 
Nervous system disorders       
Dizziness  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Headache  1  0/21 (0.00%)  0/19 (0.00%)  3/16 (18.75%) 
Psychiatric disorders       
Enuresis  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Renal and urinary disorders       
Dysuria  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Leukocyturia  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Proteinuria  1  1/21 (4.76%)  0/19 (0.00%)  1/16 (6.25%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  1/21 (4.76%)  1/19 (5.26%)  1/16 (6.25%) 
Bronchiectasis  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Bronchospasm  1  1/21 (4.76%)  1/19 (5.26%)  0/16 (0.00%) 
Cough  1  7/21 (33.33%)  6/19 (31.58%)  7/16 (43.75%) 
Epistaxis  1  0/21 (0.00%)  1/19 (5.26%)  1/16 (6.25%) 
Lung disorder  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Nasal congestion  1  4/21 (19.05%)  3/19 (15.79%)  0/16 (0.00%) 
Oropharyngeal pain  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Productive cough  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Rhinitis allergic  1  4/21 (19.05%)  3/19 (15.79%)  1/16 (6.25%) 
Rhinorrhoea  1  5/21 (23.81%)  2/19 (10.53%)  1/16 (6.25%) 
Sneezing  1  0/21 (0.00%)  1/19 (5.26%)  1/16 (6.25%) 
Skin and subcutaneous tissue disorders       
Dandruff  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Dermatitis  1  2/21 (9.52%)  1/19 (5.26%)  1/16 (6.25%) 
Dermatitis allergic  1  1/21 (4.76%)  0/19 (0.00%)  1/16 (6.25%) 
Dermatitis diaper  1  6/21 (28.57%)  1/19 (5.26%)  0/16 (0.00%) 
Dry skin  1  1/21 (4.76%)  1/19 (5.26%)  0/16 (0.00%) 
Ecchymosis  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Eczema  1  7/21 (33.33%)  4/19 (21.05%)  1/16 (6.25%) 
Lipodystrophy acquired  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Macule  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Onychomadesis  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Pityriasis alba  1  2/21 (9.52%)  0/19 (0.00%)  1/16 (6.25%) 
Prurigo  1  0/21 (0.00%)  1/19 (5.26%)  1/16 (6.25%) 
Pruritus  1  0/21 (0.00%)  1/19 (5.26%)  0/16 (0.00%) 
Rash  1  2/21 (9.52%)  2/19 (10.53%)  2/16 (12.50%) 
Rash papular  1  2/21 (9.52%)  0/19 (0.00%)  1/16 (6.25%) 
Seborrhoeic dermatitis  1  3/21 (14.29%)  0/19 (0.00%)  0/16 (0.00%) 
Skin hyperpigmentation  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Skin lesion  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Skin ulcer  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Urticaria papular  1  2/21 (9.52%)  0/19 (0.00%)  0/16 (0.00%) 
Social circumstances       
Physical assault  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
Vascular disorders       
Haematoma  1  0/21 (0.00%)  0/19 (0.00%)  1/16 (6.25%) 
1
Term from vocabulary, MedDRA 20.0
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: NCT01099579     History of Changes
Other Study ID Numbers: AI424-397
2009-016361-28 ( EudraCT Number )
First Submitted: April 6, 2010
First Posted: April 7, 2010
Results First Submitted: November 14, 2013
Results First Posted: February 6, 2014
Last Update Posted: May 24, 2018