Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Robert L. Murphy, Northwestern University
ClinicalTrials.gov Identifier:
NCT00225017
First received: September 21, 2005
Last updated: June 29, 2012
Last verified: June 2012
Results First Received: October 4, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV Infection
Hyperlipidemia
Interventions: Drug: Atazanavir
Drug: current antiretroviral regimen

  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
Recruitment period June 2005 to November 2007 at four clinics in the United States, one in Italy, and one in Argentina

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Atazanavir Switch

ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.

Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily.

Control (Continue Protease Inhibitor) ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks

Participant Flow:   Overall Study
    Atazanavir Switch     Control (Continue Protease Inhibitor)  
STARTED     26     24  
COMPLETED     26     23 [1]
NOT COMPLETED     0     1  
[1] 1 subject did not complete week 24 assessments



  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.
No text entered.

Reporting Groups
  Description
Atazanavir Switch

ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.

Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily.

Control (Continue Protease Inhibitor) ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
Total Total of all reporting groups

Baseline Measures
    Atazanavir Switch     Control (Continue Protease Inhibitor)     Total  
Number of Participants  
[units: participants]
  26     24     50  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     26     24     50  
>=65 years     0     0     0  
Age  
[units: years]
Mean ( Full Range )
  43  
  ( 25 to 68 )  
  43  
  ( 33 to 58 )  
  43  
  ( 25 to 68 )  
Gender  
[units: participants]
     
Female     4     4     8  
Male     22     20     42  
Region of Enrollment  
[units: participants]
     
United States     17     15     32  
Argentina     8     7     15  
Italy     1     2     3  



  Outcome Measures
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1.  Primary:   Percentage Change in Brachial Artery Flow Mediated (FMD) Vasodilation Between Arms From Baseline to Week 24   [ Time Frame: Baseline to week 24 ]

2.  Secondary:   Change in Total Cholesterol Levels From Baseline to Week 24   [ Time Frame: Baseline to 24 weeks ]

3.  Secondary:   Changes in LDL Particle Number From Baseline to Week 24   [ Time Frame: Baseline to 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Robert Murphy
Organization: Northwestern University
phone: 312-503-9000
e-mail: r-murphy@northwestern.edu


Publications of Results:

Responsible Party: Robert L. Murphy, Northwestern University
ClinicalTrials.gov Identifier: NCT00225017     History of Changes
Other Study ID Numbers: SABAR
Study First Received: September 21, 2005
Results First Received: October 4, 2010
Last Updated: June 29, 2012
Health Authority: United States: Food and Drug Administration