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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01099579
• Collaborator: (none)
• Enrollment: 82
• Locations: 18
• Arms: 3
• Actual Duration (Months): 83
• Patients Per Site: 4.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether atazanavir powder combined with ritonavir is safe and well tolerated and produces appropriate drug exposure in children ≥3 months to <6 years of age.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Atazanavir powder; Drug: Ritonavir oral solution; Drug: Atazanavir capsules; Drug: Ritonavir capsules	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder Boosted With Ritonavir (RTV) With an Optimized NRTI Background Therapy, in HIV Infected Pediatric Patients Greater Than or Equal to 3 Months to Less Than 6 Years. (Pediatric Atazanavir International Clinical Evaluation: the PRINCE I Study)
• Actual Study Start Date: Oct 13, 2010
• Actual Primary Completion Date: Oct 4, 2012
• Actual Study Completion Date: Sep 11, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atazanavir powder, 150 mg/Ritonavir oral solution, 80 mg Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by patient's weight on the day of first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage. 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 of ≥25kg transitioned from the powder to the capsule formulation of ATV. Patients who weighed 15 to <20 kg received ATV, 150 mg with RTV, 100 mg; those who weighed 20 to <40 kg received ATV, 200 mg, and 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.	Drug: Atazanavir powder; Powder, oral, dosed by weight. Participants who weighed 5 to <10 kg received atazanavir (ATV), 150 mg, and ritonavir (RTV), 80 mg; those who weighed 10 to <15 kg received ATV, 200 mg, and RTV, 80 mg; and those who weighed 15 to <25 kg received ATV, 250 mg, and RTV, 80 mg, once per day for 48 weeks or until pediatric indication is locally approved and participant meets requirements to receive appropriate formulation.; Other Names: Reyataz BMS-232632 ; Drug: Ritonavir oral solution; Oral solution, 80 mg/mL, once per day for 48 weeks or until pediatric indication is locally approved and participant meets requirements to receive appropriate formulation.; Other Names: Norvir ; Drug: Atazanavir capsules; Capsules, oral, dosed by weight in Stage 2. Patients who reached the age of 6 years or a weight of ≥25 kg transitioned from the powder to the capsule formulation of atazanavir (ATV). Patients who weighed 15 to <20 kg received ATV, 150 mg with RTV, 100 mg; those who weighed 20 to <40 kg received ATV, 200 mg, and 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.; Drug: Ritonavir capsules; Oral, capsules, 100 mg, administered in Stage 2 with atazanavir capsules, dosed by weight.
Experimental: Atazanavir powder, 200 mg/Ritonavir oral solution, 80 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). 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 of ≥25kg transitioned from the powder to the capsule formulation of ATV. Patients who weighed 15 to <20 kg received ATV, 150 mg with RTV, 100 mg; those who weighed 20 to <40 kg received ATV, 200 mg, and 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.	Drug: Atazanavir powder; Powder, oral, dosed by weight. Participants who weighed 5 to <10 kg received atazanavir (ATV), 150 mg, and ritonavir (RTV), 80 mg; those who weighed 10 to <15 kg received ATV, 200 mg, and RTV, 80 mg; and those who weighed 15 to <25 kg received ATV, 250 mg, and RTV, 80 mg, once per day for 48 weeks or until pediatric indication is locally approved and participant meets requirements to receive appropriate formulation.; Other Names: Reyataz BMS-232632 ; Drug: Ritonavir oral solution; Oral solution, 80 mg/mL, once per day for 48 weeks or until pediatric indication is locally approved and participant meets requirements to receive appropriate formulation.; Other Names: Norvir ; Drug: Atazanavir capsules; Capsules, oral, dosed by weight in Stage 2. Patients who reached the age of 6 years or a weight of ≥25 kg transitioned from the powder to the capsule formulation of atazanavir (ATV). Patients who weighed 15 to <20 kg received ATV, 150 mg with RTV, 100 mg; those who weighed 20 to <40 kg received ATV, 200 mg, and 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.; Drug: Ritonavir capsules; Oral, capsules, 100 mg, administered in Stage 2 with atazanavir capsules, dosed by weight.
Experimental: Atazanavir powder, 250 mg/Ritonavir oral solution, 80 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). 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 of ≥25kg transitioned from powder to the capsule formulation of ATV. Patients who weighed 15 to <20 kg received ATV, 150 mg with RTV, 100 mg; those who weighed 20 to <40 kg received ATV, 200 mg, and 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.	Drug: Atazanavir powder; Powder, oral, dosed by weight. Participants who weighed 5 to <10 kg received atazanavir (ATV), 150 mg, and ritonavir (RTV), 80 mg; those who weighed 10 to <15 kg received ATV, 200 mg, and RTV, 80 mg; and those who weighed 15 to <25 kg received ATV, 250 mg, and RTV, 80 mg, once per day for 48 weeks or until pediatric indication is locally approved and participant meets requirements to receive appropriate formulation.; Other Names: Reyataz BMS-232632 ; Drug: Ritonavir oral solution; Oral solution, 80 mg/mL, once per day for 48 weeks or until pediatric indication is locally approved and participant meets requirements to receive appropriate formulation.; Other Names: Norvir ; Drug: Atazanavir capsules; Capsules, oral, dosed by weight in Stage 2. Patients who reached the age of 6 years or a weight of ≥25 kg transitioned from the powder to the capsule formulation of atazanavir (ATV). Patients who weighed 15 to <20 kg received ATV, 150 mg with RTV, 100 mg; those who weighed 20 to <40 kg received ATV, 200 mg, and 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.; Drug: Ritonavir capsules; Oral, capsules, 100 mg, administered in Stage 2 with atazanavir capsules, dosed by weight.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation [From Day 1 to Week 48]

   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.

2. Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4 [After Day 1 to Week 48]

   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.

3. Electrocardiogram Changes From Baseline in PR Interval, QTC Bazett, and QTC Fridericia at Week 48 [From Baseline to Week 48]

   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.

4. Number of Participants With Centers for Disease Control (CDC) Class C AIDS Events [From Day 1 to Week 48]

   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.

Secondary Outcome Measures

1. Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Treatment/Weight [At Week 48]

   The definition of virologic success included HIV RNA levels <50 c/mL or 400 c/mL at the Week 48 analysis window. .

2. Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Prior Antiretroviral (ARV) Treatment Status [From Day 1 to Week 48]

   The definition of virologic success included HIV RNA levels <50 c/mL or <400 c/mL at the Week 48 analysis.

3. Mean Change From Baseline in HIV RNA Levels at Week 48 by Treatment/Weight [From Baseline to Week 48]

   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

4. Mean Change From Baseline in HIV RNA Levels at Week 48 by Prior Antiretroviral (ARV) Treatment Status [From Baseline to Week 48]

5. CD4 Cell Count Changes From Baseline at Week 48 by Treatment/Weight [From Baseline to Week 48]

6. CD4 Cell Count Changes From Baseline at Week 48 by Prior Antiretroviral (ARV) Treatment Status [From Baseline to Week 48]

7. Mean CD4 Percent Changes From Baseline at Week 48 by Treatment/Weight [From Baseline to Week 48]

8. Mean CD4 Percent Changes From Baseline at Week 48 by Antiretroviral (ARV) Treatment Status [From Baseline to Week 48]

9. Number of Participants Who Acquired Phenotypic Resistance to Atazanavir or Atazanovir/Ritonavir [After Day 1 to Week 48]

   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.

10. Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Atazanavir and Ritonavir [At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose]

11. Area Under the Concentration Curve (in 1 Dosing Interval From Time 0 to 24 Hours Post Observed Dose) (AUC[TAU])of Atazanavir and Ritonavir [At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose]

12. Time to Maximum Observed Concentration (Tmax) of Atazanavir and Ritonavir [At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose]

13. Apparent Total Body Clearance (CLT/F) of Atazanavir and Ritonavir [At Week 2]

    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.

14. Apparent Total Body Clearance Per Body Weight (CLT/F) Per Kilogram of Atazanavir and Ritonavir [At Week 2]

    Calculated as CLT/F divided by body weight

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months to 66 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• Confirmed human immunodeficiency virus (HIV)-1 infection diagnosed by a positive virologic test result on 2 separate occasions by:

• HIV DNA polymerase chain reaction

• HIV RNA with values ≥1,000 copies/mL

• Positive HIV enzyme-linked immunosorbent assay at ≥18 months of age, with confirmatory Western blot or indirect immunoflourescence antibody

• Infants and children of either sex, aged ≥3 months to <5 years and 6 months at time of first treatment, and weight >5 to <25 kg with any screening baseline plasma viral load

• Screening plasma viral load ≥1,000 copies/mL by Roche Amplicor® HIV RNA Assay

• Documented genotypic and phenotypic sensitivity at screening to ATV (fold change in susceptibility <2.2) and to at least 2 nucleoside reverse transcriptase inhibitors (NRTIs) approved in the infant's country

• Genotypic sensitivity at screening to atazanavir (ATV) and at least 2 NRTIs

• Antiretroviral (ARV) treatment-naive or ARV treatment-experienced. Treatment-experienced participants are defined by previous exposure to ARVs through either prior treatment for HIV infection or through postnatal treatment with ≥1 ARV for the prevention of mother to child transmission. For the purposes of this study, participants exposed to ARVs in utero or intrapartum may be included in the study but will be considered treatment naive. ATV-naive participants must have genotypic sensitivity at screening to ATV (fold change in susceptibility <2.2) and to both components of the local NRTI backbone. The NRTIs must have been approved for pediatric use at the local country level.

Key Exclusion Criteria:

• Experienced participants who received ATV or ATV/ritonavir (RTV) at any time prior to study enrollment or with a history of 2 or more protease inhibitor failures

• ARV-naïve or -experienced HIV-1 infected patients with contraindication to study medications syncope

• Family history of QTc interval syndrome, Brugada syndrome, right ventricular dysplasia, or a corrected QTc interval at screening of >440 ms

• One of the following cardiac rhythm abnormalities documented on screening electrocardiogram: 1st degree atrioventricular (AV) block as defined by protocol, type I 2nd degree AV block while awake, type II 2nd degree AV block at any time, complete AV block at any time, or age-adjusted heart rate <2nd percentile) History of pancreatitis, peripheral neuropathy, malignancy that requires systemic therapy, or any medical condition which, in the opinion of the investigator, added undue risk to trial participation

• Malabsorption syndrome

• Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment

• Weight <5 or ≥25 kg at date of first dose (Day 1).

• Grade 2 aspartate transaminase or alanine transaminase abnormalities

• Hypersensitivity to any component of the study medication formulations (ATV/RTV, or a locally prescribed NRTI with a pediatric indication)

• Infants and children of either gender <3 months or ≥5 years and 6 months at the time of first treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Sao Paolo	SAO Paulo	Brazil	01246-900
2	Local Institution	Santiago	Metropolitana	Chile	8380418
3	Local Institution	Santiago	Metropolitana	Chile
4	Local Institution	Df	Distrito Federal	Mexico	06720
5	Local Institution	Guadalajara	Jalisco	Mexico	44160
6	Local Institution	Guadalajara	Jalisco	Mexico	44280
7	Local Institution	Merida	Yucatan	Mexico	97000
8	Local Institution	Oaxaca		Mexico	71256
9	Local Institution	Puebla		Mexico	72000
10	Local Institution	Lima		Peru	1
11	Local Institution	Lima		Peru
12	Local Institution	Bloemfontein	FREE State	South Africa	9301
13	Local Institution	Coronationville	Gauteng	South Africa	2092
14	Local Institution	Soweto	Gauteng	South Africa	2001
15	Local Institution	Congella	KWA ZULU Natal	South Africa	4013
16	Local Institution	Cape Town	Western CAPE	South Africa	7505
17	Local Institution	Bangkok		Thailand	10330
18	Local Institution	Bangkok		Thailand	10700

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Patient Recruiting

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT01099579
• Other Study ID Numbers: AI424-397; 2009-016361-28
• First Posted: Apr 7, 2010
• Last Update Posted: May 24, 2018
• Last Verified: Apr 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: HIV, Pediatric
• Additional relevant MeSH terms: HIV Infections; Ritonavir; Atazanavir Sulfate

Study Results

Participant Flow

Pre-assignment Detail	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
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	14	15
NOT COMPLETED	4	5	1
Period Title: Stage 1 (ATV Powder Formulation)
STARTED	16	14	15
COMPLETED	10	9	9
NOT COMPLETED	6	5	6

Baseline Characteristics

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
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 Participants	21	19	16	56
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	7.3 (4.05)	35.4 (11.63)	52.1 (10.49)	29.6 (20.72)
Sex: Female, Male (Count of Participants)
Female	10 47.6%	12 63.2%	6 37.5%	28 50%
Male	11 52.4%	7 36.8%	10 62.5%	28 50%
Race/Ethnicity, Customized (Count of Participants)
Not Hispanic or Latino	0 0%	0 0%	1 6.3%	1 1.8%
Not reported	21 100%	19 100%	15 93.8%	55 98.2%
Race/Ethnicity, Customized (Count of 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%	1 5.3%	0 0%	1 1.8%
Other	6 28.6%	3 15.8%	3 18.8%	12 21.4%
Country (Count of Participants)
Chile	1 4.8%	2 10.5%	3 18.8%	6 10.7%
Mexico	2 9.5%	3 15.8%	4 25%	9 16.1%
Peru	1 4.8%	0 0%	1 6.3%	2 3.6%
South Africa	17 81%	13 68.4%	8 50%	38 67.9%
Thailand	0 0%	1 5.3%	0 0%	1 1.8%
HIV RNA (Log10 c/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Log10 c/mL]	4.77 (0.602)	4.83 (0.268)	4.18 (0.727)	4.62 (0.617)
HIV RNA (c/mL) [Number]
<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 (Cells/mm^3) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Cells/mm^3]	1594.1 (897.19)	1107.4 (643.25)	661.1 (302.60)	1192.6 (784.08)
CD4 Percent (Percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage]	25.4 (12.11)	22.0 (9.35)	27.5 (9.85)	24.8 (10.61)
CD4 Percent (Count of 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%	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 (Count of 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%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation
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

Outcome Measure Data

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
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.
Measure Participants	21	19	16
Deaths	0 0%	0 0%	0 0%
SAEs	5 23.8%	2 10.5%	4 25%
AEs leading to discontinuation	4 19%	1 5.3%	0 0%

2. Secondary Outcome

Title	Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Treatment/Weight
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

Outcome Measure Data

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
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.
Measure Participants	21	19	14
HIV RNA levels <50 c/mL	47.6 226.7%	68.4 360%	71.4 446.3%
HIV RNA levels <400 c/mL	66.7 317.6%	73.7 387.9%	85.7 535.6%

3. 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
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

Outcome Measure Data

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
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.
Measure Participants	20	34
HIV RNA levels <50 c/mL	56.3 268.1%	68.2 358.9%
HIV RNA levels <400 c/mL	65.6 312.4%	86.4 454.7%

4. Secondary Outcome

Title	Mean Change From Baseline in HIV RNA Levels at Week 48 by Treatment/Weight
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

Outcome Measure Data

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
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.
Measure Participants	17	15	13
Mean (Standard Error) [Log10 c/mL]	-2.61 (0.3111)	-2.93 (0.1678)	-2.40 (0.2412)

5. Secondary Outcome

Title	Mean Change From Baseline in HIV RNA Levels at Week 48 by Prior Antiretroviral (ARV) Treatment Status
Time Frame	From Baseline to Week 48

Outcome Measure Data

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
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.
Measure Participants	34	22
Mean (Standard Error) [Log10 c/mL]	-2.53 (0.2452)	-2.81 (0.1296)

6. Secondary Outcome

Title	CD4 Cell Count Changes From Baseline at Week 48 by Treatment/Weight
Time Frame	From Baseline to Week 48

Outcome Measure Data

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
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.
Measure Participants	13	11	5
Mean (Standard Error) [Cells/mm^3]	550.1 (285.24)	225.3 (198.34)	373.8 (68.83)

7. Primary Outcome

Title	Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4
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

Outcome Measure Data

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
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.
Measure Participants	21	19	16
Hemoglobin (n=20, 17, 15)	2 9.5%	3 15.8%	0 0%
Neutrophils, absolute (n=20, 17, 15)	3 14.3%	2 10.5%	0 0%
ALT/SGPT (n=20, 18, 15)	5 23.8%	0 0%	1 6.3%
AST/SGOT (n=20, 18, 15)	1 4.8%	0 0%	0 0%
Alkaline phosphatase (n=20, 18, 15)	0 0%	1 5.3%	0 0%
Total bilirubin (n=20, 18, 15)	2 9.5%	0 0%	3 18.8%
Amylase (n=20, 18, 15)	8 38.1%	5 26.3%	1 6.3%
Lipase (n=20, 18, 15)	0 0%	1 5.3%	1 6.3%
Uric acid n=20, 18, 15)	0 0%	0 0%	1 6.3%

8. Primary Outcome

Title	Electrocardiogram Changes From Baseline in PR Interval, QTC Bazett, and QTC Fridericia at Week 48
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

Outcome Measure Data

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
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.
Measure Participants	17	15	13
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)

9. Primary Outcome

Title	Number of Participants With Centers for Disease Control (CDC) Class C AIDS Events
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

Outcome Measure Data

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
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.
Measure Participants	21	19	16
Number [Participants]	1 4.8%	1 5.3%	0 0%

10. Secondary Outcome

Title	CD4 Cell Count Changes From Baseline at Week 48 by Prior Antiretroviral (ARV) Treatment Status
Time Frame	From Baseline to Week 48

Outcome Measure Data

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
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.
Measure Participants	34	22
Mean (Standard Error) [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
Time Frame	From Baseline to Week 48

Outcome Measure Data

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
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.
Measure Participants	14	12	6
Mean (Standard Error) [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
Time Frame	From Baseline to Week 48

Outcome Measure Data

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
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.
Measure Participants	34	22
Mean (Standard Error) [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
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

Outcome Measure Data

Analysis Population Description

Participants who met the criteria for virologic failure

Arm/Group Title	ARV-experienced	ARV-naive
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.
Measure Participants	6	8
Atazanavir	0 0%	0 0%
Ritonavir	0 0%	0 0%

14. Secondary Outcome

Title	Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Atazanavir and Ritonavir
Time Frame	At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose

Outcome Measure Data

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
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.
Measure Participants	20	18	15
Atazanavir Cmax	4131	5197	6172
Atazanavir Cmin	336	572	698
Ritonavir Cmax (n=19, 18, 15)	2919	2634	1838
Ritonavir Cmin (n=18, 16, 15)	41.8	143	51.0

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
Time Frame	At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose

Outcome Measure Data

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
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.
Measure Participants	20	18	15
AUC(TAU) Atazanavir	32503	50305	61485
AUC(TAU) Ritonavir (n=19, 18, 15)	17439	20510	13640

16. Secondary Outcome

Title	Time to Maximum Observed Concentration (Tmax) of Atazanavir and Ritonavir
Time Frame	At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose

Outcome Measure Data

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
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.
Measure Participants	20	18	15
Tmax Atazanavir	1.58	1.97	4.0
Tmax Ritonavir	1.8	2.9	4.0

17. Secondary Outcome

Title	Apparent Total Body Clearance (CLT/F) of Atazanavir and Ritonavir
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

Outcome Measure Data

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
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.
Measure Participants	20	18	15
CLT/F Atazanavir	4.61	3.98	4.07
CLT/F Ritonavir (n=19, 18, 15	4.59	3.90	5.87

18. Secondary Outcome

Title	Apparent Total Body Clearance Per Body Weight (CLT/F) Per Kilogram of Atazanavir and Ritonavir
Description	Calculated as CLT/F divided by body weight
Time Frame	At Week 2

Outcome Measure Data

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
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.
Measure Participants	20	18	15
CLT/F per kilogram Atazanavir	0.65	0.32	0.24
CLT/F per kilogram Ritonavir (n=19, 18, 15)	0.65	0.32	0.35

Adverse Events

Time Frame	From Day 1 to Week 48
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
Arm/Group Description
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/19 (0%)		0/16 (0%)
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/21 (33.3%)		5/19 (26.3%)		5/16 (31.3%)
Blood and lymphatic system disorders
Neutropenia	1/21 (4.8%)		0/19 (0%)		1/16 (6.3%)
Thrombocytopenia	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Hepatobiliary disorders
Drug-induced liver injury	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Infections and infestations
Dengue fever	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Gastroenteritis	1/21 (4.8%)		0/19 (0%)		0/16 (0%)
Herpes zoster disseminated	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Influenza	1/21 (4.8%)		0/19 (0%)		0/16 (0%)
Lymphadenitis bacterial	1/21 (4.8%)		0/19 (0%)		0/16 (0%)
Meningitis	1/21 (4.8%)		0/19 (0%)		1/16 (6.3%)
Otitis media chronic	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Pneumonia	2/21 (9.5%)		0/19 (0%)		0/16 (0%)
Sepsis	1/21 (4.8%)		0/19 (0%)		0/16 (0%)
Varicella zoster virus infection	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Injury, poisoning and procedural complications
Humerus fracture	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Investigations
Electrocardiogram qt prolonged	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Transaminases increased	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Nervous system disorders
Febrile convulsion	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Seizure	1/21 (4.8%)		0/19 (0%)		0/16 (0%)
Psychiatric disorders
Suicide attempt	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Respiratory, thoracic and mediastinal disorders
Bronchiectasis	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Other (Not Including 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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/21 (100%)		18/19 (94.7%)		15/16 (93.8%)
Blood and lymphatic system disorders
Anaemia	1/21 (4.8%)		2/19 (10.5%)		0/16 (0%)
Basophilia	1/21 (4.8%)		1/19 (5.3%)		1/16 (6.3%)
Basophilopenia	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Eosinophilia	1/21 (4.8%)		2/19 (10.5%)		2/16 (12.5%)
Leukopenia	0/21 (0%)		1/19 (5.3%)		1/16 (6.3%)
Lymphadenitis	2/21 (9.5%)		0/19 (0%)		0/16 (0%)
Lymphadenopathy	4/21 (19%)		4/19 (21.1%)		0/16 (0%)
Lymphocytosis	1/21 (4.8%)		1/19 (5.3%)		1/16 (6.3%)
Lymphopenia	0/21 (0%)		1/19 (5.3%)		1/16 (6.3%)
Monocytopenia	0/21 (0%)		1/19 (5.3%)		1/16 (6.3%)
Monocytosis	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Neutropenia	1/21 (4.8%)		1/19 (5.3%)		1/16 (6.3%)
Splenomegaly	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Cardiac disorders
Atrioventricular block first degree	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Ear and labyrinth disorders
Cerumen impaction	0/21 (0%)		0/19 (0%)		3/16 (18.8%)
Ear pain	0/21 (0%)		1/19 (5.3%)		3/16 (18.8%)
Excessive cerumen production	1/21 (4.8%)		1/19 (5.3%)		0/16 (0%)
Otorrhoea	0/21 (0%)		0/19 (0%)		2/16 (12.5%)
Tympanic membrane perforation	1/21 (4.8%)		1/19 (5.3%)		1/16 (6.3%)
Eye disorders
Conjunctival hyperaemia	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Conjunctivitis allergic	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Eye pruritus	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Gastrointestinal disorders
Abdominal distension	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Abdominal pain	0/21 (0%)		1/19 (5.3%)		2/16 (12.5%)
Abdominal pain upper	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Anal pruritus	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Dental caries	4/21 (19%)		3/19 (15.8%)		3/16 (18.8%)
Diarrhoea	11/21 (52.4%)		6/19 (31.6%)		7/16 (43.8%)
Gastritis	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Oral mucosal blistering	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Tongue geographic	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Toothache	1/21 (4.8%)		2/19 (10.5%)		2/16 (12.5%)
Vomiting	9/21 (42.9%)		8/19 (42.1%)		4/16 (25%)
General disorders
Asthenia	0/21 (0%)		0/19 (0%)		2/16 (12.5%)
Local swelling	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Pyrexia	3/21 (14.3%)		7/19 (36.8%)		5/16 (31.3%)
Hepatobiliary disorders
Hepatomegaly	4/21 (19%)		1/19 (5.3%)		0/16 (0%)
Hyperbilirubinaemia	1/21 (4.8%)		2/19 (10.5%)		4/16 (25%)
Jaundice	1/21 (4.8%)		3/19 (15.8%)		2/16 (12.5%)
Ocular icterus	2/21 (9.5%)		1/19 (5.3%)		1/16 (6.3%)
Infections and infestations
Acarodermatitis	6/21 (28.6%)		0/19 (0%)		1/16 (6.3%)
Bacteriuria	1/21 (4.8%)		1/19 (5.3%)		1/16 (6.3%)
Bronchitis	2/21 (9.5%)		4/19 (21.1%)		2/16 (12.5%)
Candida nappy rash	5/21 (23.8%)		0/19 (0%)		0/16 (0%)
Conjunctivitis	2/21 (9.5%)		2/19 (10.5%)		1/16 (6.3%)
Ear infection	1/21 (4.8%)		1/19 (5.3%)		0/16 (0%)
Enterobiasis	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Folliculitis	1/21 (4.8%)		0/19 (0%)		1/16 (6.3%)
Fungal infection	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Fungal skin infection	2/21 (9.5%)		1/19 (5.3%)		0/16 (0%)
Gastroenteritis	9/21 (42.9%)		5/19 (26.3%)		2/16 (12.5%)
Helminthic infection	5/21 (23.8%)		2/19 (10.5%)		1/16 (6.3%)
Herpes simplex	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Hordeolum	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Impetigo	4/21 (19%)		2/19 (10.5%)		2/16 (12.5%)
Influenza	3/21 (14.3%)		1/19 (5.3%)		2/16 (12.5%)
Lice infestation	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Lower respiratory tract infection	2/21 (9.5%)		3/19 (15.8%)		1/16 (6.3%)
Lower respiratory tract infection viral	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Molluscum contagiosum	0/21 (0%)		1/19 (5.3%)		1/16 (6.3%)
Nasopharyngitis	3/21 (14.3%)		1/19 (5.3%)		5/16 (31.3%)
Oral candidiasis	9/21 (42.9%)		0/19 (0%)		0/16 (0%)
Oral herpes	0/21 (0%)		1/19 (5.3%)		2/16 (12.5%)
Otitis externa	3/21 (14.3%)		3/19 (15.8%)		1/16 (6.3%)
Otitis media	8/21 (38.1%)		4/19 (21.1%)		4/16 (25%)
Otitis media acute	3/21 (14.3%)		2/19 (10.5%)		2/16 (12.5%)
Otitis media chronic	3/21 (14.3%)		1/19 (5.3%)		2/16 (12.5%)
Parasitic gastroenteritis	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Pharyngitis	5/21 (23.8%)		4/19 (21.1%)		4/16 (25%)
Pharyngotonsillitis	1/21 (4.8%)		0/19 (0%)		2/16 (12.5%)
Pneumonia	4/21 (19%)		2/19 (10.5%)		0/16 (0%)
Pulmonary tuberculosis	2/21 (9.5%)		0/19 (0%)		0/16 (0%)
Respiratory tract infection	1/21 (4.8%)		1/19 (5.3%)		2/16 (12.5%)
Rhinitis	1/21 (4.8%)		1/19 (5.3%)		2/16 (12.5%)
Sinusitis	0/21 (0%)		0/19 (0%)		2/16 (12.5%)
Skin infection	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Tinea capitis	4/21 (19%)		2/19 (10.5%)		2/16 (12.5%)
Tinea faciei	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Tinea infection	1/21 (4.8%)		1/19 (5.3%)		3/16 (18.8%)
Tonsillitis	7/21 (33.3%)		2/19 (10.5%)		1/16 (6.3%)
Tooth abscess	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Upper respiratory tract infection	11/21 (52.4%)		6/19 (31.6%)		5/16 (31.3%)
Urinary tract infection	6/21 (28.6%)		2/19 (10.5%)		0/16 (0%)
Varicella	2/21 (9.5%)		1/19 (5.3%)		1/16 (6.3%)
Viral rash	1/21 (4.8%)		0/19 (0%)		1/16 (6.3%)
Viral upper respiratory tract infection	4/21 (19%)		8/19 (42.1%)		4/16 (25%)
Vulvovaginal candidiasis	1/21 (4.8%)		1/19 (5.3%)		0/16 (0%)
Injury, poisoning and procedural complications
Animal bite	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Arthropod bite	5/21 (23.8%)		0/19 (0%)		1/16 (6.3%)
Burns first degree	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Contusion	1/21 (4.8%)		1/19 (5.3%)		0/16 (0%)
Foreign body	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Limb injury	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Overdose	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Scar	1/21 (4.8%)		2/19 (10.5%)		1/16 (6.3%)
Skin abrasion	0/21 (0%)		1/19 (5.3%)		1/16 (6.3%)
Upper limb fracture	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Investigations
Alanine aminotransferase increased	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Amylase increased	2/21 (9.5%)		0/19 (0%)		1/16 (6.3%)
Blood bilirubin increased	1/21 (4.8%)		0/19 (0%)		1/16 (6.3%)
Blood sodium increased	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Body temperature increased	1/21 (4.8%)		0/19 (0%)		1/16 (6.3%)
Cardiac murmur	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Crystal urine present	0/21 (0%)		1/19 (5.3%)		1/16 (6.3%)
Electrocardiogram abnormal	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Lipase increased	2/21 (9.5%)		1/19 (5.3%)		0/16 (0%)
Urinary sediment present	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Weight decreased	4/21 (19%)		3/19 (15.8%)		1/16 (6.3%)
Metabolism and nutrition disorders
Decreased appetite	5/21 (23.8%)		3/19 (15.8%)		2/16 (12.5%)
Hyperamylasaemia	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Hypercholesterolaemia	1/21 (4.8%)		0/19 (0%)		1/16 (6.3%)
Hyperlipasaemia	1/21 (4.8%)		1/19 (5.3%)		0/16 (0%)
Hypertriglyceridaemia	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Back pain	1/21 (4.8%)		0/19 (0%)		1/16 (6.3%)
Joint swelling	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Tendonitis	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma	0/21 (0%)		0/19 (0%)		2/16 (12.5%)
Nervous system disorders
Dizziness	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Headache	0/21 (0%)		0/19 (0%)		3/16 (18.8%)
Psychiatric disorders
Enuresis	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Renal and urinary disorders
Dysuria	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Leukocyturia	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Proteinuria	1/21 (4.8%)		0/19 (0%)		1/16 (6.3%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/21 (4.8%)		1/19 (5.3%)		1/16 (6.3%)
Bronchiectasis	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Bronchospasm	1/21 (4.8%)		1/19 (5.3%)		0/16 (0%)
Cough	7/21 (33.3%)		6/19 (31.6%)		7/16 (43.8%)
Epistaxis	0/21 (0%)		1/19 (5.3%)		1/16 (6.3%)
Lung disorder	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Nasal congestion	4/21 (19%)		3/19 (15.8%)		0/16 (0%)
Oropharyngeal pain	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Productive cough	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Rhinitis allergic	4/21 (19%)		3/19 (15.8%)		1/16 (6.3%)
Rhinorrhoea	5/21 (23.8%)		2/19 (10.5%)		1/16 (6.3%)
Sneezing	0/21 (0%)		1/19 (5.3%)		1/16 (6.3%)
Skin and subcutaneous tissue disorders
Dandruff	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Dermatitis	2/21 (9.5%)		1/19 (5.3%)		1/16 (6.3%)
Dermatitis allergic	1/21 (4.8%)		0/19 (0%)		1/16 (6.3%)
Dermatitis diaper	6/21 (28.6%)		1/19 (5.3%)		0/16 (0%)
Dry skin	1/21 (4.8%)		1/19 (5.3%)		0/16 (0%)
Ecchymosis	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Eczema	7/21 (33.3%)		4/19 (21.1%)		1/16 (6.3%)
Lipodystrophy acquired	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Macule	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Onychomadesis	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Pityriasis alba	2/21 (9.5%)		0/19 (0%)		1/16 (6.3%)
Prurigo	0/21 (0%)		1/19 (5.3%)		1/16 (6.3%)
Pruritus	0/21 (0%)		1/19 (5.3%)		0/16 (0%)
Rash	2/21 (9.5%)		2/19 (10.5%)		2/16 (12.5%)
Rash papular	2/21 (9.5%)		0/19 (0%)		1/16 (6.3%)
Seborrhoeic dermatitis	3/21 (14.3%)		0/19 (0%)		0/16 (0%)
Skin hyperpigmentation	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Skin lesion	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Skin ulcer	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Urticaria papular	2/21 (9.5%)		0/19 (0%)		0/16 (0%)
Social circumstances
Physical assault	0/21 (0%)		0/19 (0%)		1/16 (6.3%)
Vascular disorders
Haematoma	0/21 (0%)		0/19 (0%)		1/16 (6.3%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.