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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024537-23 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1: Atazanavir + Ritonavir | Experimental | Participants received atazanavir powder orally (dosed by weight: 5 to <10 kg=150 mg, 5 to <10 kg=200 mg, 10 to <15 kg=200 mg, 15 to <25 kg=250 mg, 25 to <35 kg=300 mg) once daily for 24 to 48 weeks or a weight ≥35 kg. Participants also received ritonavir once daily for 24 to 48 weeks or weight ≥35 kg in the form of 80-mg/mL solution, orally (dosed by weight 5 to <25 kg=80 mg, 25 to <35 kg=100 mg); 100-mg capsule, orally (dosed by weight 25 to <35 kg=100 mg); or 100-mg tablet, orally (dosed by weight 25 to <35 kg=100 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atazanavir Sulphate | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day one to week 300 (approximately 22-Jan-2018) |
| 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 | Day one to week 300 (approximately 22-Jan-2018) |
| 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. | Day one to week 300 (approximately 22-Jan-2018) |
| Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children'S National Medical Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| SUNY Upstate Medical University |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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Of 160 participants enrolled, 99 received treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Stage 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 15, 2014 | Jul 23, 2018 |
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| Ritonavir |
| Drug |
|
|
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. |
| Day one to week 300 (approximately 22-Jan-2018) |
| Day 1 of treatment to weeks 24 and 48 |
| Mean Change From Baseline in HIV RNA on ATV Powder | Human immunodeficiency virus ribonucleic acid (HIV RNA) change from baseline using observed values | Baseline to Weeks 24 and 48 |
| Mean Change From Baseline in CD4 Percent on ATV Powder | Change in CD4 percent using observed values | Baseline to Weeks 24 and 48 |
| CD4 Cell Count Changes From Baseline on ATV Powder | CD4 cell count change from baseline using observed values | Baseline to Weeks 24 and 48 |
| 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 | Baseline through Week 48 |
| 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 | Baseline to Week 2 |
| 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 | Baseline to Week 2 |
| 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 | Baseline to Week 2 |
| Syracuse |
| New York |
| 13210 |
| United States |
| Local Institution | Buenos Aires, Bs As | Buenos Aires | 1141 | Argentina |
| Local Institution | Bunos Aires | Buenos Aires | 1425 | Argentina |
| Local Institution | Recife | Pernambuco | 50070-500 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Local Institution | Ribeirão Preto | São Paulo | 14049-900 | Brazil |
| Local Institution | Santiago | Santiago Metropolitan | 8380418 | Chile |
| Local Institution | Santiago | Santiago Metropolitan | Chile |
| Local Institution | Guadalajara | Jalisco | 44160 | Mexico |
| Local Institution | Guadalajara | Jalisco | 44280 | Mexico |
| Local Institution | Df | Mexico City | 06720 | Mexico |
| Local Institution | Mérida | Yucatán | 97000 | Mexico |
| Local Institution | Oaxaca City | 71256 | Mexico |
| Local Institution | Puebla City | 72000 | Mexico |
| Local Institution | Warsaw | 01-201 | Poland |
| Local Institution | Bucharest | 72205 | Romania |
| Local Institution | Saint Petersburg | 189635 | Russia |
| Local Institution | Saint Petersburg | 198103 | Russia |
| Local Institution | Smolensk | 214006 | Russia |
| Local Institution | Port Elizabeth | Eastern Cape | 6001 | South Africa |
| Local Institution | Port Elizabeth | Eastern Cape | 6014 | South Africa |
| Local Institution | Bloemfontein | Free State | 9301 | South Africa |
| Local Institution | Benoni | Gauteng | 1501 | South Africa |
| Local Institution | Coronationville | Gauteng | 2092 | South Africa |
| Local Institution | Pretoria | Gauteng | 0001 | South Africa |
| Local Institution | Soweto | Gauteng | 2001 | South Africa |
| Local Institution | Parrow Valley | Western Cape | 7505 | South Africa |
| Local Institution | Barcelona | 08950 | Spain |
| Local Institution | Madrid | 28041 | Spain |
| Local Institution | Birmingham | WEST Midlands | B9 5ST | United Kingdom |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Treatment Stage 2 |
|
|
All participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Months |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Country | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who received at least 1 dose of study drug | Posted | Number | Participants | Day one to week 300 (approximately 22-Jan-2018) |
|
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| ||||||||||||||||||||||||||||||||||||||
| 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 | Posted | Number | participants | Day one to week 300 (approximately 22-Jan-2018) |
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| 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. | All participants who received at least 1 dose of study drug. | Posted | Number | Participants | Day one to week 300 (approximately 22-Jan-2018) |
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| 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. | All participants who received at least 1 dose of study drug. n=number of participants evaluable | Posted | Number | Participants | Day one to week 300 (approximately 22-Jan-2018) |
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| 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. | 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 | Posted | Number | Participants | Day 1 of treatment to weeks 24 and 48 |
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| Secondary | Mean Change From Baseline in HIV RNA on ATV Powder | Human immunodeficiency virus ribonucleic acid (HIV RNA) change from baseline using observed values | All participants who received at least 1 dose of study drug. n=participants with both baseline and time point results | Posted | Mean | Standard Error | Log copies per millileter | Baseline to Weeks 24 and 48 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in CD4 Percent on ATV Powder | Change in CD4 percent using observed values | All participants with both baseline and time point results; n=number of participants evaluable at time point | Posted | Mean | Standard Error | Percent Change | Baseline to Weeks 24 and 48 |
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| Secondary | CD4 Cell Count Changes From Baseline on ATV Powder | CD4 cell count change from baseline using observed values | All participants with both baseline and time point results | Posted | Mean | Standard Error | Cells/mm^3 | Baseline to Weeks 24 and 48 |
| |||||||||||||||||||||||||||||||||||||||
| 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 | All participants with virologic failure. | Posted | Number | Participants | Baseline through Week 48 |
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| 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 | Posted | Mean | Standard Deviation | ng/mL | Baseline to Week 2 |
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| 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 | Posted | Mean | Standard Deviation | ng/mL | Baseline to Week 2 |
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| 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 | Posted | Mean | Standard Deviation | ng.h./mL | Baseline to Week 2 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | B/L Weight 5 to lt 10kg (ATV 150mg) | 0 | 23 | 6 | 23 | 22 | 23 | |
| EG001 | B/L Weight 5 to lt 10kg (ATV 200mg) | 0 | 12 | 3 | 12 | 10 | 12 | |
| EG002 | B/L Weight 10 to lt 15kg | 0 | 21 | 8 | 21 | 19 | 21 | |
| EG003 | B/L Weight 15 to lt 25kg | 0 | 35 | 10 | 35 | 31 | 35 | |
| EG004 | B/L Weight 25 to lt 35kg | 0 | 8 | 0 | 8 | 7 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Immune reconstitution inflammatory syndrome | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Dysentery | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Hepatitis a | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Infective corneal ulcer | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pertussis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonitis chemical | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Varicocele | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Accidental exposure to product | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Basophilia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Iritis | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myopia | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ocular icterus | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Candida nappy rash | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Helminthic infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Tinea capitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Foreign body in ear | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Head lag | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Product taste abnormal | Product Issues | MedDRA 20.1 | Systematic Assessment |
| |
| Pica | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Urticaria chronic | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysmorphism | Congenital, familial and genetic disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Strabismus | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Skin candida | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 2, 2017 | Oct 11, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000069446 | Atazanavir Sulfate |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
Not provided
Not provided
| Adverse Event |
|
| Withdrawal by Subject |
|
| Poor compliance/noncompliance |
|
| Lost to Follow-up |
|
| Capsules received at state hospital |
|
| Subject no longer meets study criteria |
|
| Switched to another formulation |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black/African American |
|
| Other |
|
| South America |
|
| Africa |
|
| Europe |
|
| Brazil |
|
| Chile |
|
| Mexico |
|
| Poland |
|
| Romania |
|
| Russia |
|
| South Africa |
|
| Spain |
|
| United States |
|
| AEs leading to discontinuation |
|
| Hyperbilirubinemia related adverse events |
|
| Jaundice |
|
| Atrioventricular block, first degree |
|
| Tachycardia |
|
| Rash |
|
| OG001 |
| 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 |
| 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG001 |
| 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|
| OG002 | 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. |
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