HIV
Conditions
Keywords
Pediatric
Brief summary
The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse transcriptase inhibitor in pediatric patients aged ≥3 months to \<11 years.
Interventions
DRUGRitonavir
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 11 Years
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Key Inclusion Criteria: * Confirmed HIV-1 infection diagnosed by protocol criteria * Screening HIV RNA level ≥1000 copies/mL * ≥3 months to \<11 years of age at time of first treatment * Antiretroviral-naive or -experienced * At screening, all participants must have genotypic sensitivity to atazanavir and at least 2 nucleoside reverse transcriptase inhibitors (NRTIs), which must be approved for pediatric use at the local country. * Antiretroviral-experienced patients must also have documented phenotypic sensitivity at screening to atazanavir (Fold Change in susceptibility \<2.2) and to at least 2 NRTIs that are approved in their country Key
Exclusion criteria
* Experienced participants who received atazanavir or atazanavir/ritonavir at any time prior to study enrollment or who have a history of 2 or more protease inhibitor failures * Antiretroviral-naïve or -experienced HIV-1-infected patients with contraindication to study medications * Cardiac rhythm abnormalities * Need for tenofovir * Weight \<5 or ≥35kg * \>Grade 2 abnormality in aspartate transaminase/alanine transaminase levels * Coinfection with either hepatitis B or C virus * Any active Centers for Disease Control and Prevention Category C clinical condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Day one to week 300 (approximately 22-Jan-2018) | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. |
| Number of Participants Who Experienced a SAE on ATV Powder | Day one to week 300 (approximately 22-Jan-2018) | SAE= any of the the following: is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event (defined as a medical event(s) that may not be immediately life threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the subject or may require intervention \[eg, medical, surgical\] to prevent one of the other serious outcomes listed in the definition above.) Examples of such events include, but are not limited to, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization |
| Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Day one to week 300 (approximately 22-Jan-2018) | The CDC disease staging system assesses the severity of HIV disease by CD4 cell counts and by the presence of specific HIV-related conditions. CD4 counts are classified as 1: ≥500 cells/µL, 2: 200-499 cells/µL, and 3: \<200 cells/µL. Children with HIV infection are also classified in each of several categories. Category N: Not symptomatic. Category A: Mildly symptomatic. Category B: Moderately symptomatic. Category C: Severely symptomatic. |
| Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Day one to week 300 (approximately 22-Jan-2018) | Criteria of the Division of AIDS for grading the severity of adult and pediatric adverse events as follows: Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=potentially life-threatening. Neutrophils (absolute) (adult and infants \>7 days): Gr 1=1.000-1300/mm\^3; Gr 2=750-999 mm\^3; Gr 3=500-749 mm\^3; Gr 4= \<500 mm\^3. Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase: Gr 1=1.25-2.5\*upper limit of normal (ULN); Gr 2=2.6-5.0\*ULN; Gr 3=5.1-10.0\*ULN; Gr 4= \>10.0\*ULN. Bilirubin, total (adults and infants \>14 days): Gr 1=1.1-1.5\*ULN; Gr 2=1.6-2.5\*ULN; Gr 3=2.6-5.0\*ULN; Gr 4= \>5.0\*ULN. Lipase: Gr 1=1.1-1.5\*ULN; Gr 2=1.6-3.0\*ULN; Gr 3=3.1-5.0\*ULN; Gr 4= \>5.0\*ULN. Bicarbonate, serum low: Gr 1=16.0 mEq/L-\<lower limit of normal; Gr 2=11.0-15.9 mEq/L; Gr 3=8.0-10.9 mEq/L; Gr 4= \<8 mEq/L. By criteria of the World Health Organization: Amylase: Gr 1=1.0-1.39\*ULN; Gr 2=1.40-2.09\*ULN; Gr 3.=2.10-5.0\*ULN; Gr 4= \>5.0\*ULN. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | Baseline through Week 48 | Newly emergent substitutions are on-treatment substitutions that were not detected at baseline.Viral rebound in the resistance analysis was defined as: Less than a 1 log10 drop from baseline in plasma HIV RNA level by Week 16, confirmed by a second plasma HIV RNA level redrawn within 2 and 4 weeks from original sample. Or, a plasma HIV RNA level \>200 c/mL after Week 24, confirmed by a second plasma HIV RNA level redrawn within 2 and 4 weeks from original sample. Or, repeated plasma HIV RNA level ≥50 c/mL after Week 48. Viral rebound was defined as a plasma HIV RNA level ≥400 c/mL at any time in a patient who had previously achieved a plasma HIV RNA level \<50 c/mL. Or, a plasma HIV RNA level ≥50 c/mL and \<1,000 c/mL followed by a return to virologic suppression was considered a viral blip and not a viral rebound. NRTI=nucleoside reverse transcriptase inhibitor |
| Maximum Observed Plasma Concentration (Cmax) | Baseline to Week 2 | To describe the PK profile of ATV powder formulation with RTV in pediatric subjects weighing 25 - \< 35 kg and/or 6 to \< 11 years of age and for the new 5 - \< 10 kg cohort (200 mg ATV and 80 mg RTV) in terms of ATV Cmax |
| Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Day 1 of treatment to weeks 24 and 48 | Virologic success includes patients with HIV RNA \<50 copies/mL. Two cohorts were assessed: The Atazanavir Powder Cohort=patients who received treatment and did not switch to capsule before analysis Week 24 or before their HIV RNA Week 24 assessment, and the Eligible Week 48 Atazanavir Powder Cohort=patients who initiated study treatment at least 48 weeks before last person last visit and did not switch to capsule before analysis Week 48 or before their HIV RNA Week 48 assessment. |
| Area Under the Concentration-Time Curve [AUC(TAU)] | Baseline to Week 2 | To describe the PK profile of ATV powder formulation with RTV in pediatric subjects weighing 25 - \< 35 kg and/or 6 to \< 11 years of age and for the new 5 - \< 10 kg cohort (200 mg ATV and 80 mg RTV) in terms of ATV AUC |
| Minimum Plasma Concentration (Cmin) | Baseline to Week 2 | To describe the PK profile of ATV powder formulation with RTV in pediatric subjects weighing 25 - \< 35 kg and/or 6 to \< 11 years of age and for the new 5 - \< 10 kg cohort (200 mg ATV and 80 mg RTV) in terms of ATV Cmin |
| Mean Change From Baseline in HIV RNA on ATV Powder | Baseline to Weeks 24 and 48 | Human immunodeficiency virus ribonucleic acid (HIV RNA) change from baseline using observed values |
| Mean Change From Baseline in CD4 Percent on ATV Powder | Baseline to Weeks 24 and 48 | Change in CD4 percent using observed values |
| CD4 Cell Count Changes From Baseline on ATV Powder | Baseline to Weeks 24 and 48 | CD4 cell count change from baseline using observed values |
Countries
Argentina, Brazil, Chile, Mexico, Poland, Romania, Russia, South Africa, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
Of 160 participants enrolled, 99 received treatment.
Participants by arm
| Arm | Count |
|---|---|
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation. | 23 |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) Stage 1: HIV-infected pediatric patients weighing 5 to \<10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation. | 12 |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation. | 21 |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) Stage 1: HIV-infected pediatric patients weighing 15 to \<25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation. | 35 |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) Stage 1: HIV-infected pediatric patients weighing 10 to \<15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation. | 8 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Treatment Stage 1 | Adverse Event | 1 | 2 | 2 | 1 | 1 |
| Treatment Stage 1 | Lack of Efficacy | 3 | 1 | 3 | 3 | 1 |
| Treatment Stage 1 | Lost to Follow-up | 1 | 1 | 0 | 0 | 0 |
| Treatment Stage 1 | No longer meets study criteria | 1 | 1 | 0 | 1 | 0 |
| Treatment Stage 1 | Other | 1 | 0 | 0 | 1 | 0 |
| Treatment Stage 1 | Poor compliance/noncompliance | 0 | 1 | 0 | 2 | 0 |
| Treatment Stage 1 | Withdrawal by Subject | 1 | 2 | 0 | 1 | 0 |
| Treatment Stage 2 | Adverse Event | 2 | 0 | 0 | 3 | 0 |
| Treatment Stage 2 | Capsules received at state hospital | 1 | 0 | 0 | 0 | 0 |
| Treatment Stage 2 | Lack of Efficacy | 2 | 1 | 3 | 1 | 0 |
| Treatment Stage 2 | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 |
| Treatment Stage 2 | Poor compliance/noncompliance | 1 | 0 | 1 | 3 | 1 |
| Treatment Stage 2 | Subject no longer meets study criteria | 0 | 0 | 0 | 1 | 0 |
| Treatment Stage 2 | Switched to another formulation | 1 | 1 | 0 | 0 | 0 |
| Treatment Stage 2 | Withdrawal by Subject | 3 | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) |
|---|---|---|---|---|---|---|
| Age, Continuous | 42.5 Months STANDARD_DEVIATION 31.58 | 10.5 Months STANDARD_DEVIATION 9.21 | 37.4 Months STANDARD_DEVIATION 12.44 | 67.2 Months STANDARD_DEVIATION 16.7 | 8.4 Months STANDARD_DEVIATION 6.42 | 93.4 Months STANDARD_DEVIATION 15.53 |
| Country Argentina | 4 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants |
| Country Brazil | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Country Chile | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants |
| Country Mexico | 15 Participants | 1 Participants | 7 Participants | 4 Participants | 1 Participants | 2 Participants |
| Country Poland | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Country Romania | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Country Russia | 4 Participants | 0 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants |
| Country South Africa | 64 Participants | 10 Participants | 8 Participants | 21 Participants | 20 Participants | 5 Participants |
| Country Spain | 3 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants |
| Country United States | 3 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 91 Participants | 10 Participants | 18 Participants | 33 Participants | 22 Participants | 8 Participants |
| Race/Ethnicity, Customized Black/African American | 57 Participants | 6 Participants | 7 Participants | 20 Participants | 19 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 10 Participants | 4 Participants | 2 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 32 Participants | 2 Participants | 12 Participants | 13 Participants | 2 Participants | 3 Participants |
| Region of Enrollment Africa | 64 Participants | 10 Participants | 8 Participants | 21 Participants | 20 Participants | 5 Participants |
| Region of Enrollment Europe | 9 Participants | 0 Participants | 3 Participants | 6 Participants | 0 Participants | 0 Participants |
| Region of Enrollment North America | 18 Participants | 1 Participants | 9 Participants | 4 Participants | 2 Participants | 2 Participants |
| Region of Enrollment South America | 8 Participants | 1 Participants | 1 Participants | 4 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 51 Participants | 6 Participants | 12 Participants | 18 Participants | 12 Participants | 3 Participants |
| Sex: Female, Male Male | 48 Participants | 6 Participants | 9 Participants | 17 Participants | 11 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 12 | 0 / 21 | 0 / 35 | 0 / 8 |
| other Total, other adverse events | 22 / 23 | 10 / 12 | 19 / 21 | 31 / 35 | 7 / 8 |
| serious Total, serious adverse events | 6 / 23 | 3 / 12 | 8 / 21 | 10 / 35 | 0 / 8 |
Outcome results
Primary
Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
Time frame: Day one to week 300 (approximately 22-Jan-2018)
Population: All participants who received at least 1 dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Atrioventricular block, first degree | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Tachycardia | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Deaths | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | AEs leading to discontinuation | 3 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Hyperbilirubinemia related adverse events | 2 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Rash | 3 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Jaundice | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Tachycardia | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Hyperbilirubinemia related adverse events | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Atrioventricular block, first degree | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Deaths | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | AEs leading to discontinuation | 2 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Jaundice | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Rash | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Atrioventricular block, first degree | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Deaths | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Hyperbilirubinemia related adverse events | 9 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Jaundice | 3 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Tachycardia | 1 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Rash | 4 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | AEs leading to discontinuation | 2 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Hyperbilirubinemia related adverse events | 7 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | AEs leading to discontinuation | 2 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Tachycardia | 0 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Deaths | 0 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Atrioventricular block, first degree | 1 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Rash | 5 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Jaundice | 3 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Rash | 1 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Jaundice | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | AEs leading to discontinuation | 1 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Hyperbilirubinemia related adverse events | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Deaths | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Tachycardia | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder | Atrioventricular block, first degree | 0 Participants |
Primary
Number of Participants Who Experienced a SAE on ATV Powder
SAE= any of the the following: is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event (defined as a medical event(s) that may not be immediately life threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the subject or may require intervention \[eg, medical, surgical\] to prevent one of the other serious outcomes listed in the definition above.) Examples of such events include, but are not limited to, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization
Time frame: Day one to week 300 (approximately 22-Jan-2018)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants Who Experienced a SAE on ATV Powder | 6 participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants Who Experienced a SAE on ATV Powder | 3 participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants Who Experienced a SAE on ATV Powder | 8 participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants Who Experienced a SAE on ATV Powder | 8 participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants Who Experienced a SAE on ATV Powder | 0 participants |
Primary
Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder
The CDC disease staging system assesses the severity of HIV disease by CD4 cell counts and by the presence of specific HIV-related conditions. CD4 counts are classified as 1: ≥500 cells/µL, 2: 200-499 cells/µL, and 3: \<200 cells/µL. Children with HIV infection are also classified in each of several categories. Category N: Not symptomatic. Category A: Mildly symptomatic. Category B: Moderately symptomatic. Category C: Severely symptomatic.
Time frame: Day one to week 300 (approximately 22-Jan-2018)
Population: All participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Pulmonary tuberculosis | 2 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Lymph node tuberculosis | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Tuberculosis | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Oropharyngeal Candidiasis | 1 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Pulmonary tuberculosis | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Oropharyngeal Candidiasis | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Lymph node tuberculosis | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Tuberculosis | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Oropharyngeal Candidiasis | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Lymph node tuberculosis | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Tuberculosis | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Pulmonary tuberculosis | 1 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Pulmonary tuberculosis | 0 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Lymph node tuberculosis | 1 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Oropharyngeal Candidiasis | 0 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Tuberculosis | 1 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Oropharyngeal Candidiasis | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Tuberculosis | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Lymph node tuberculosis | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder | Pulmonary tuberculosis | 0 Participants |
Primary
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder
Criteria of the Division of AIDS for grading the severity of adult and pediatric adverse events as follows: Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=potentially life-threatening. Neutrophils (absolute) (adult and infants \>7 days): Gr 1=1.000-1300/mm\^3; Gr 2=750-999 mm\^3; Gr 3=500-749 mm\^3; Gr 4= \<500 mm\^3. Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase: Gr 1=1.25-2.5\*upper limit of normal (ULN); Gr 2=2.6-5.0\*ULN; Gr 3=5.1-10.0\*ULN; Gr 4= \>10.0\*ULN. Bilirubin, total (adults and infants \>14 days): Gr 1=1.1-1.5\*ULN; Gr 2=1.6-2.5\*ULN; Gr 3=2.6-5.0\*ULN; Gr 4= \>5.0\*ULN. Lipase: Gr 1=1.1-1.5\*ULN; Gr 2=1.6-3.0\*ULN; Gr 3=3.1-5.0\*ULN; Gr 4= \>5.0\*ULN. Bicarbonate, serum low: Gr 1=16.0 mEq/L-\<lower limit of normal; Gr 2=11.0-15.9 mEq/L; Gr 3=8.0-10.9 mEq/L; Gr 4= \<8 mEq/L. By criteria of the World Health Organization: Amylase: Gr 1=1.0-1.39\*ULN; Gr 2=1.40-2.09\*ULN; Gr 3.=2.10-5.0\*ULN; Gr 4= \>5.0\*ULN.
Time frame: Day one to week 300 (approximately 22-Jan-2018)
Population: All participants who received at least 1 dose of study drug. n=number of participants evaluable
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Albumin | 1 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Aspartate aminotransferase | 2 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Neutrophils (absolute) | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Calcium, High | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Chloride, Low | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Alkaline phosphatase | 1 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Alanine aminotransferase | 4 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Total bilirubin | 4 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Glucose, Fasting, Low | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Amylase | 15 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | LDL Cholesterol, Fasting | 0 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Lipase | 3 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Bicarbonate | 2 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Total Cholesterol, Fasting | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Glucose, Fasting, Low | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Albumin | 1 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Bicarbonate | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | LDL Cholesterol, Fasting | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Alanine aminotransferase | 1 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Total bilirubin | 1 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Calcium, High | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Total Cholesterol, Fasting | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Aspartate aminotransferase | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Amylase | 7 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Chloride, Low | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Lipase | 2 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Neutrophils (absolute) | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Alkaline phosphatase | 2 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Total Cholesterol, Fasting | 1 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Alkaline phosphatase | 1 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Chloride, Low | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Lipase | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Total bilirubin | 10 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Glucose, Fasting, Low | 1 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Amylase | 6 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | LDL Cholesterol, Fasting | 1 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Albumin | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Alanine aminotransferase | 1 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Bicarbonate | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Calcium, High | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Neutrophils (absolute) | 4 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Aspartate aminotransferase | 1 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Chloride, Low | 1 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Neutrophils (absolute) | 6 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Alanine aminotransferase | 2 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Aspartate aminotransferase | 0 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Alkaline phosphatase | 0 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Total bilirubin | 5 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Amylase | 6 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Bicarbonate | 0 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Lipase | 2 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Albumin | 1 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Calcium, High | 1 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Total Cholesterol, Fasting | 0 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | LDL Cholesterol, Fasting | 0 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Glucose, Fasting, Low | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Lipase | 1 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Calcium, High | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Alanine aminotransferase | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Total Cholesterol, Fasting | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Amylase | 1 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Aspartate aminotransferase | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Neutrophils (absolute) | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Glucose, Fasting, Low | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | LDL Cholesterol, Fasting | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Total bilirubin | 2 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Alkaline phosphatase | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Albumin | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Chloride, Low | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder | Bicarbonate | 0 Participants |
Secondary
Area Under the Concentration-Time Curve [AUC(TAU)]
To describe the PK profile of ATV powder formulation with RTV in pediatric subjects weighing 25 - \< 35 kg and/or 6 to \< 11 years of age and for the new 5 - \< 10 kg cohort (200 mg ATV and 80 mg RTV) in terms of ATV AUC
Time frame: Baseline to Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Area Under the Concentration-Time Curve [AUC(TAU)] | 49387.12 ng.h./mL | Standard Deviation 26890.782 |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Area Under the Concentration-Time Curve [AUC(TAU)] | 59671.80 ng.h./mL | Standard Deviation 31706.655 |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Area Under the Concentration-Time Curve [AUC(TAU)] | 56356.00 ng.h./mL | Standard Deviation 35233.024 |
Secondary
CD4 Cell Count Changes From Baseline on ATV Powder
CD4 cell count change from baseline using observed values
Time frame: Baseline to Weeks 24 and 48
Population: All participants with both baseline and time point results
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | CD4 Cell Count Changes From Baseline on ATV Powder | Week 48 | -409.8 Cells/mm^3 | Standard Error 437.686 |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | CD4 Cell Count Changes From Baseline on ATV Powder | Week 24 | 218.7 Cells/mm^3 | Standard Error 259.102 |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | CD4 Cell Count Changes From Baseline on ATV Powder | Week 24 | 67.8 Cells/mm^3 | Standard Error 425.659 |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | CD4 Cell Count Changes From Baseline on ATV Powder | Week 48 | 400.0 Cells/mm^3 | Standard Error 156.021 |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | CD4 Cell Count Changes From Baseline on ATV Powder | Week 24 | 247.1 Cells/mm^3 | Standard Error 110.739 |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | CD4 Cell Count Changes From Baseline on ATV Powder | Week 24 | 246.1 Cells/mm^3 | Standard Error 72.044 |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | CD4 Cell Count Changes From Baseline on ATV Powder | Week 48 | 335.4 Cells/mm^3 | Standard Error 108.925 |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | CD4 Cell Count Changes From Baseline on ATV Powder | Week 48 | 213.0 Cells/mm^3 | — |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | CD4 Cell Count Changes From Baseline on ATV Powder | Week 24 | 145.8 Cells/mm^3 | Standard Error 78.443 |
Secondary
Maximum Observed Plasma Concentration (Cmax)
To describe the PK profile of ATV powder formulation with RTV in pediatric subjects weighing 25 - \< 35 kg and/or 6 to \< 11 years of age and for the new 5 - \< 10 kg cohort (200 mg ATV and 80 mg RTV) in terms of ATV Cmax
Time frame: Baseline to Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Maximum Observed Plasma Concentration (Cmax) | 5776.70 ng/mL | Standard Deviation 3417.208 |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Maximum Observed Plasma Concentration (Cmax) | 5644.12 ng/mL | Standard Deviation 3093.516 |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Maximum Observed Plasma Concentration (Cmax) | 4893.75 ng/mL | Standard Deviation 2523.959 |
Secondary
Mean Change From Baseline in CD4 Percent on ATV Powder
Change in CD4 percent using observed values
Time frame: Baseline to Weeks 24 and 48
Population: All participants with both baseline and time point results; n=number of participants evaluable at time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Mean Change From Baseline in CD4 Percent on ATV Powder | Week 48 | 2.8 Percent Change | Standard Error 3.167 |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Mean Change From Baseline in CD4 Percent on ATV Powder | Week 24 | 5.1 Percent Change | Standard Error 1.521 |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Mean Change From Baseline in CD4 Percent on ATV Powder | Week 24 | 4.0 Percent Change | Standard Error 1.581 |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Mean Change From Baseline in CD4 Percent on ATV Powder | Week 48 | 8.9 Percent Change | Standard Error 2.182 |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Mean Change From Baseline in CD4 Percent on ATV Powder | Week 24 | 5.4 Percent Change | Standard Error 2.448 |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Mean Change From Baseline in CD4 Percent on ATV Powder | Week 48 | 7.5 Percent Change | Standard Error 1.825 |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Mean Change From Baseline in CD4 Percent on ATV Powder | Week 24 | 6.3 Percent Change | Standard Error 1.28 |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Mean Change From Baseline in CD4 Percent on ATV Powder | Week 24 | -0.3 Percent Change | Standard Error 4.349 |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Mean Change From Baseline in CD4 Percent on ATV Powder | Week 48 | 1.0 Percent Change | — |
Secondary
Mean Change From Baseline in HIV RNA on ATV Powder
Human immunodeficiency virus ribonucleic acid (HIV RNA) change from baseline using observed values
Time frame: Baseline to Weeks 24 and 48
Population: All participants who received at least 1 dose of study drug. n=participants with both baseline and time point results
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Mean Change From Baseline in HIV RNA on ATV Powder | Week 24 | -2.10 Log copies per millileter | Standard Error 0.2863 |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Mean Change From Baseline in HIV RNA on ATV Powder | Week 48 | -2.31 Log copies per millileter | Standard Error 0.3174 |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Mean Change From Baseline in HIV RNA on ATV Powder | Week 24 | -3.07 Log copies per millileter | Standard Error 0.478 |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Mean Change From Baseline in HIV RNA on ATV Powder | Week 48 | -4.06 Log copies per millileter | Standard Error 0.1649 |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Mean Change From Baseline in HIV RNA on ATV Powder | Week 24 | -2.69 Log copies per millileter | Standard Error 0.2257 |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Mean Change From Baseline in HIV RNA on ATV Powder | Week 48 | -2.91 Log copies per millileter | Standard Error 0.1883 |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Mean Change From Baseline in HIV RNA on ATV Powder | Week 48 | -2.70 Log copies per millileter | Standard Error 0.1269 |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Mean Change From Baseline in HIV RNA on ATV Powder | Week 24 | -2.66 Log copies per millileter | Standard Error 0.155 |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Mean Change From Baseline in HIV RNA on ATV Powder | Week 24 | -2.24 Log copies per millileter | Standard Error 0.3821 |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Mean Change From Baseline in HIV RNA on ATV Powder | Week 48 | -3.97 Log copies per millileter | — |
Secondary
Minimum Plasma Concentration (Cmin)
To describe the PK profile of ATV powder formulation with RTV in pediatric subjects weighing 25 - \< 35 kg and/or 6 to \< 11 years of age and for the new 5 - \< 10 kg cohort (200 mg ATV and 80 mg RTV) in terms of ATV Cmin
Time frame: Baseline to Week 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Minimum Plasma Concentration (Cmin) | 718.90 ng/mL | Standard Deviation 432.747 |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Minimum Plasma Concentration (Cmin) | 857.06 ng/mL | Standard Deviation 599.221 |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Minimum Plasma Concentration (Cmin) | 1030.64 ng/mL | Standard Deviation 1070.932 |
Secondary
Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48
Newly emergent substitutions are on-treatment substitutions that were not detected at baseline.Viral rebound in the resistance analysis was defined as: Less than a 1 log10 drop from baseline in plasma HIV RNA level by Week 16, confirmed by a second plasma HIV RNA level redrawn within 2 and 4 weeks from original sample. Or, a plasma HIV RNA level \>200 c/mL after Week 24, confirmed by a second plasma HIV RNA level redrawn within 2 and 4 weeks from original sample. Or, repeated plasma HIV RNA level ≥50 c/mL after Week 48. Viral rebound was defined as a plasma HIV RNA level ≥400 c/mL at any time in a patient who had previously achieved a plasma HIV RNA level \<50 c/mL. Or, a plasma HIV RNA level ≥50 c/mL and \<1,000 c/mL followed by a return to virologic suppression was considered a viral blip and not a viral rebound. NRTI=nucleoside reverse transcriptase inhibitor
Time frame: Baseline through Week 48
Population: All participants with virologic failure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | Any PI substitutions | 4 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | NRTI | 1 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | Any IAS-USA PI substitutions | 1 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | Any select RT substitutions | 2 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | Any PI substitutions | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | Any IAS-USA PI substitutions | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | Any select RT substitutions | 1 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | NRTI | 1 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | Any PI substitutions | 4 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | Any select RT substitutions | 2 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | NRTI | 2 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | Any IAS-USA PI substitutions | 2 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | Any IAS-USA PI substitutions | 0 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | Any select RT substitutions | 1 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | Any PI substitutions | 3 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | NRTI | 1 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | Any select RT substitutions | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | Any IAS-USA PI substitutions | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | Any PI substitutions | 0 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48 | NRTI | 0 Participants |
Secondary
Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort
Virologic success includes patients with HIV RNA \<50 copies/mL. Two cohorts were assessed: The Atazanavir Powder Cohort=patients who received treatment and did not switch to capsule before analysis Week 24 or before their HIV RNA Week 24 assessment, and the Eligible Week 48 Atazanavir Powder Cohort=patients who initiated study treatment at least 48 weeks before last person last visit and did not switch to capsule before analysis Week 48 or before their HIV RNA Week 48 assessment.
Time frame: Day 1 of treatment to weeks 24 and 48
Population: For efficacy of atazanavir powder to Week 24: Atazanavir Powder Cohort. For efficacy of atazanavir powder efficacy to Week 48 (n): Eligible Week 48 Atazanavir Powder Cohort
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Week 48:HIV RNA<400 copies/mL | 14 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Week 24: HIV RNA<50 copies/mL | 10 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Week 24: HIV RNA<400 copies/mL | 15 Participants |
| Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Week 48: HIV RNA<50 copies/mL | 11 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Week 48:HIV RNA<400 copies/mL | 1 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Week 48: HIV RNA<50 copies/mL | 0 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Week 24: HIV RNA<50 copies/mL | 2 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg) | Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Week 24: HIV RNA<400 copies/mL | 5 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Week 48: HIV RNA<50 copies/mL | 6 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Week 48:HIV RNA<400 copies/mL | 14 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Week 24: HIV RNA<50 copies/mL | 10 Participants |
| Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg) | Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Week 24: HIV RNA<400 copies/mL | 15 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Week 24: HIV RNA<50 copies/mL | 19 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Week 24: HIV RNA<400 copies/mL | 24 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Week 48:HIV RNA<400 copies/mL | 22 Participants |
| Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg) | Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Week 48: HIV RNA<50 copies/mL | 18 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Week 48:HIV RNA<400 copies/mL | 1 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Week 24: HIV RNA<400 copies/mL | 6 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Week 48: HIV RNA<50 copies/mL | 1 Participants |
| Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg) | Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort | Week 24: HIV RNA<50 copies/mL | 5 Participants |