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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003300-21 | EudraCT Number |
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The purpose of this study is to collect safety clinical data in HIV-infected pediatric patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are receiving atazanavir capsule boosted with ritonavir and an optimized nucleoside reverse transcriptase inhibitor backbone therapy as part of their antiretroviral regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atazanavir, 150 mg + Ritonavir, 100 mg (weight:15 to <20 kg) | Active Comparator | Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years. |
|
| Atazanavir, 200 mg + Ritonavir, 100 mg (weight: 20 to <40 kg) | Active Comparator | Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years. |
|
| Atazanavir, 300 mg + Ritonavir, 100 mg (weight: ≥ 40 kg) | Active Comparator | Participants with baseline weight ≥ 40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atazanavir | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Grade 2-4 Related AEs, Grade 3-4 AEs, and Centers for Disease Control (CDC) Class C AIDS Events | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death. | From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months) |
| Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Hematocrit (%): Grade (Gr) 1= ≥28.5- <31.5; Gr 2= ≥24- <28.5; Gr 3= ≥19.5- <24; Gr 4= <19.5. Hemoglobin (g/dL): Grade (Gr)1=8.5-10.0; Gr 2=7.5-8.4; Gr 3=6.50-7.4; Gr 4= <6.5. Platelets (/mm^3): Gr 1=100,000-124,999; Gr 2=50,000-99,999; Gr 3=25,000-49,999; Gr 4= <25,000. White blood cells (/mm^3): Gr 1=2000-2500; Gr 2=1500-1999; Gr 3=1000-1499; Gr 4= <1000. Neutrophils (/mm^3): Gr 1=1000-1500; Gr 2= ≥750-1000; Gr 3= ≥500-750; Gr 4= <500. Alanine transaminase (ALT), alkaline phosphatase (ALP), aspartate transaminase (AST) (*upper limit of normal [ULN]): Gr 1=1.5-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10.0; Gr 4= >10.0. Total bilirubin (adult and pediatric >14 days) (*ULN): Gr 1=1.1-1.5; Gr 2=1.6-2.5; Gr 3=2.6-5.0; Gr 4= >5.0. Albumin (g/dL): Gr 1= 3.1- <LLN; Gr 2=2.0-2.9; Gr 3= <2.0; Gr 4=NA. Amylase (*ULN): Gr 1=1.10-1.39; Gr 2=1.40-2.09; Gr 3=2.10-5.0; Gr 4= >5. Lipase (*ULN): Gr 1=1.1-1.5; Gr 2=1.6-3.0; Gr 3=3.1-5.0; Gr 4= >5.0. | After first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months) |
| Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Blood urea nitrogen (*upper limit of normal [ULN]): Grade (Gr) 1=1.25-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10; Gr 4= >10. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12; Gr 3=12.1-15.0; Gr 4= >15.0. Bicarbonate (mEqL): Gr 1= 19.0-21.0; Gr 2=15.0-18.0; Gr 3=41-45; Gr 4= >45. Calcium, low (mg/dL): Gr 1=7.8-8.4; Gr 2=7.0-7.7; Gr 3=6.1-6.9; Gr 4= <6.1.Potassium (mEq/L), high: Gr 1=5.6-6.0; Gr 2=6.1-6.5; Gr 3=6.6-7.0; Gr 4= >7.0. Potassium (mEq/L), low: Gr 1=3.1-3.4; Gr 2=2.5-2.9; Gr 3=2.0-2.4; Gr 4= <2.0. Sodium (mEq/L), low: Gr 1=130-135; Gr 2=125-129; Gr 3=121-124; Gr 4= <1. Total cholesterol, fasting (mg/dL): Gr 1=200-239; Gr 2=240-300; Gr 3= >300; Gr 4=Not applicable (NA). Low-density lipoprotein (LDL) cholesterol, fasting (mg/dL): Gr 1=130-159; Gr 2=160-190; Gr 3= >190; Gr 4= NA. Glucose, low (mg/dL): Gr 1= 55-64; Gr 2=40-54; Gr 3=30-39; Gr 4= <30. Glucose, fasting (mg/dL): Gr 1=110-125; Gr 2=126-250; Gr 3=251-500; Gr 4 >500. |
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Inclusion Criteria:
Exclusion Criteria:
Experienced participants who received atazanavir with or without ritonavir at any time prior to study enrollment
Antiretroviral-naive or -experienced HIV-1 infected patients with contraindication to study medications
Documented cardiac conduction abnormality, significant cardiac dysfunction, or a history syncope
Family history of QTc interval syndrome, Brugada syndrome, right ventricular dysplasia, or a corrected QTc interval of >440 ms at screening
One of the following cardiac rhythm abnormalities documented on the screening electrocardiogram:
Coinfection with either hepatitis B or C virus
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children'S Hospital | Phoenix | Arizona | 85016 | United States | ||
| Grady Health System Ponce Family And Youth Clinic |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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Overall, 108 participants were enrolled, and 59 received treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir in capsule formation plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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Not provided
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|
| Ritonavir | Drug |
|
|
| After first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Children'S Medical Center Of Dallas | Dallas | Texas | 75235 | United States |
| Local Institution | Buenos Aires, Bs As | Buenos Aires | 1141 | Argentina |
| Local Institution | Buenos Aires | 1181 | Argentina |
| Local Institution | Buenos Aires | 1425 | Argentina |
| Local Institution | Salvador | Estado de Bahia | 40110-160 | Brazil |
| Local Institution | Salvador | Estado de Bahia | 40110 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90035 | Brazil |
| Local Institution | São Paulo | São Paulo | 01416-901 | Brazil |
| Local Institution | São Paulo | 01246 | Brazil |
| Local Institution | Santiago | Santiago Metropolitan | 8207257 | Chile |
| Local Institution | Santiago | Santiago Metropolitan | 8380418 | Chile |
| Local Institution | Guadalajara | Jalisco | 44280 | Mexico |
| Local Institution | Monterrey | Nuevo León | 64000 | Mexico |
| Local Institution | Mérida | Yucatán | 97000 | Mexico |
| Local Institution | Puebla City | 72000 | Mexico |
| Local Institution | Lima | 1 | Peru |
| Local Institution | Lima | LIMA 10 | Peru |
| Local Institution | Moscow | 129110 | Russia |
| Local Institution | Saint Petersburg | 190103 | Russia |
| Local Institution | Port Elizabeth | Eastern Cape | 6001 | South Africa |
| Local Institution | Bloemfontein | Free State | 9301 | South Africa |
| Local Institution | Soweto | Gauteng | 2013 | South Africa |
| Local Institution | Cape Town | Western Cape | 7505 | South Africa |
| Local Institution | Cape Town | Western Cape | 7530 | South Africa |
| FG001 | Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years. |
| FG002 | Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg) | Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir in capsule formation plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years. |
| BG001 | Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years. |
| BG002 | Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years. |
| BG003 | 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 | Years |
| |||||||||||||||
| Age, Customized | Median | Full Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | Participants |
| ||||||||||||||||
| Country | Number | 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 Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Grade 2-4 Related AEs, Grade 3-4 AEs, and Centers for Disease Control (CDC) Class C AIDS Events | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death. | All participants who received at least 1 dose of study drug | Posted | Number | Participants | From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months) |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 | Hematocrit (%): Grade (Gr) 1= ≥28.5- <31.5; Gr 2= ≥24- <28.5; Gr 3= ≥19.5- <24; Gr 4= <19.5. Hemoglobin (g/dL): Grade (Gr)1=8.5-10.0; Gr 2=7.5-8.4; Gr 3=6.50-7.4; Gr 4= <6.5. Platelets (/mm^3): Gr 1=100,000-124,999; Gr 2=50,000-99,999; Gr 3=25,000-49,999; Gr 4= <25,000. White blood cells (/mm^3): Gr 1=2000-2500; Gr 2=1500-1999; Gr 3=1000-1499; Gr 4= <1000. Neutrophils (/mm^3): Gr 1=1000-1500; Gr 2= ≥750-1000; Gr 3= ≥500-750; Gr 4= <500. Alanine transaminase (ALT), alkaline phosphatase (ALP), aspartate transaminase (AST) (*upper limit of normal [ULN]): Gr 1=1.5-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10.0; Gr 4= >10.0. Total bilirubin (adult and pediatric >14 days) (*ULN): Gr 1=1.1-1.5; Gr 2=1.6-2.5; Gr 3=2.6-5.0; Gr 4= >5.0. Albumin (g/dL): Gr 1= 3.1- <LLN; Gr 2=2.0-2.9; Gr 3= <2.0; Gr 4=NA. Amylase (*ULN): Gr 1=1.10-1.39; Gr 2=1.40-2.09; Gr 3=2.10-5.0; Gr 4= >5. Lipase (*ULN): Gr 1=1.1-1.5; Gr 2=1.6-3.0; Gr 3=3.1-5.0; Gr 4= >5.0. | All participants who received at least 1 dose of study drug | Posted | Number | Participants | After first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued) | Blood urea nitrogen (*upper limit of normal [ULN]): Grade (Gr) 1=1.25-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10; Gr 4= >10. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12; Gr 3=12.1-15.0; Gr 4= >15.0. Bicarbonate (mEqL): Gr 1= 19.0-21.0; Gr 2=15.0-18.0; Gr 3=41-45; Gr 4= >45. Calcium, low (mg/dL): Gr 1=7.8-8.4; Gr 2=7.0-7.7; Gr 3=6.1-6.9; Gr 4= <6.1.Potassium (mEq/L), high: Gr 1=5.6-6.0; Gr 2=6.1-6.5; Gr 3=6.6-7.0; Gr 4= >7.0. Potassium (mEq/L), low: Gr 1=3.1-3.4; Gr 2=2.5-2.9; Gr 3=2.0-2.4; Gr 4= <2.0. Sodium (mEq/L), low: Gr 1=130-135; Gr 2=125-129; Gr 3=121-124; Gr 4= <1. Total cholesterol, fasting (mg/dL): Gr 1=200-239; Gr 2=240-300; Gr 3= >300; Gr 4=Not applicable (NA). Low-density lipoprotein (LDL) cholesterol, fasting (mg/dL): Gr 1=130-159; Gr 2=160-190; Gr 3= >190; Gr 4= NA. Glucose, low (mg/dL): Gr 1= 55-64; Gr 2=40-54; Gr 3=30-39; Gr 4= <30. Glucose, fasting (mg/dL): Gr 1=110-125; Gr 2=126-250; Gr 3=251-500; Gr 4 >500. | All participants who received at least 1 dose of study drug | Posted | Number | Participants | After first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months) |
|
From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Not provided
Not provided
| 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 15 to Less Than 20 kg | Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir in capsule formation plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years. | 0 | 3 | 1 | 3 | 3 | 3 |
| EG001 | B/L Weight 20 to Less Than 40 kg | Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years. | 0 | 33 | 3 | 33 | 26 | 33 |
| EG002 | B/L Weight Greater Than and Equal 40 kg | Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years. | 1 | 23 | 4 | 23 | 20 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Post streptococcal glomerulonephritis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ocular icterus | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | 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 | Please email: | Clinical.Trials@bms.com |
| 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
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black/African American |
|
| Other |
|
| Europe |
|
| North America |
|
| South America |
|
| Brazil |
|
| Chile |
|
| Mexico |
|
| Peru |
|
| Russia |
|
| South Africa |
|
| United States |
|
| Title | Measurements |
|---|---|
|
| AEs leading to discontinuation |
|
| Grade 2-4 related AEs |
|
| Grade 3-4 AEs |
|
| CDC Class C AIDS events |
|
| OG001 | Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years. |
| OG002 | Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years. |
|
|
| OG001 | Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg) | Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years. |
| OG002 | Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg) | Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients were eligible to receive study treatment, with regular 12-week visits, until the age of 18 years. |
|
|