Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV in Patients Aged 6 to 18 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01691794
First received: September 21, 2012
Last updated: October 27, 2015
Last verified: October 2015
Results First Received: October 27, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV, Pediatric
Interventions: Drug: Atazanavir
Drug: Ritonavir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Overall, 108 participants were enrolled, and 59 received treatment.

Reporting Groups
  Description
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 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) 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) 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.

Participant Flow:   Overall Study
    Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)     Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)     Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)  
STARTED     3     33     23  
COMPLETED     3 [1]   30 [1]   20 [1]
NOT COMPLETED     0     3     3  
Adverse Event                 0                 0                 1  
No longer meets study criteria                 0                 2                 0  
Lack of Efficacy                 0                 1                 1  
Poor compliance/noncompliance                 0                 0                 1  
[1] Completed Phase 1 (to Week 24)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 dose of study drug.

Reporting Groups
  Description
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 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) 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) 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.
Total Total of all reporting groups

Baseline Measures
    Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)     Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)     Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)     Total  
Number of Participants  
[units: participants]
  3     33     23     59  
Age  
[units: Years]
Mean (Standard Deviation)
  6.0  (0.0)     10.7  (2.67)     14.7  (1.72)     12.0  (3.26)  
Age, Customized  
[units: Years]
Median (Full Range)
  6.0   (6 to 6)     11.0   (6 to 16)     15.0   (11 to 17)     12.0   (6 to 17)  
Gender  
[units: Participants]
       
Female     2     17     11     30  
Male     1     16     12     29  
Ethnicity (NIH/OMB)  
[units: Participants]
       
Hispanic or Latino     0     1     2     3  
Not Hispanic or Latino     1     2     2     5  
Unknown or Not Reported     2     30     19     51  
Race/Ethnicity, Customized  
[units: Participants]
       
White     1     5     4     10  
Black/African American     2     24     9     35  
Other     0     4     10     14  
Region of Enrollment  
[units: Participants]
       
Africa     2     24     8     34  
Europe     0     1     0     1  
North America     1     0     3     4  
South America     0     8     12     20  
Country  
[units: Participants]
       
Argentina     0     3     0     3  
Brazil     0     3     4     7  
Chile     0     1     2     3  
Mexico     1     0     1     2  
Peru     0     1     6     7  
Russia     0     1     0     1  
South Africa     2     24     8     34  
United States     0     0     2     2  



  Outcome Measures
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1.  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, Cardiac Abnormalities, and Centers for Disease Control (CDC) Class C AIDS Events   [ Time Frame: Day 1 of treatment through Week 24 ]

2.  Primary:   Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4   [ Time Frame: Day 1 of treatment to Week 24 ]

3.  Primary:   Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued)   [ Time Frame: Day 1 of treatment through Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided


Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01691794     History of Changes
Other Study ID Numbers: AI424-452
2011-003300-21 ( EudraCT Number )
Study First Received: September 21, 2012
Results First Received: October 27, 2015
Last Updated: October 27, 2015
Health Authority: United States: Food and Drug Administration