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Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study (SABAR)

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ClinicalTrials.gov Identifier: NCT00225017
Recruitment Status : Completed
First Posted : September 23, 2005
Results First Posted : August 2, 2012
Last Update Posted : August 2, 2012
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Robert L. Murphy, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV Infection
Hyperlipidemia
Interventions Drug: Atazanavir
Drug: current antiretroviral regimen
Enrollment 50
Recruitment Details Recruitment period June 2005 to November 2007 at four clinics in the United States, one in Italy, and one in Argentina
Pre-assignment Details  
Arm/Group Title Atazanavir Switch Control (Continue Protease Inhibitor)
Hide Arm/Group Description

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.

ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
Period Title: Overall Study
Started 26 24
Completed 26 23 [1]
Not Completed 0 1
[1]
1 subject did not complete week 24 assessments
Arm/Group Title Atazanavir Switch Control (Continue Protease Inhibitor) Total
Hide Arm/Group Description

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.

ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 26 24 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
 100.0%
24
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 26 participants 24 participants 50 participants
43
(25 to 68)
43
(33 to 58)
43
(25 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 participants
Female
4
  15.4%
4
  16.7%
8
  16.0%
Male
22
  84.6%
20
  83.3%
42
  84.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 participants
United States 17 15 32
Argentina 8 7 15
Italy 1 2 3
1.Primary Outcome
Title Percentage Change in Brachial Artery Flow Mediated (FMD) Vasodilation Between Arms From Baseline to Week 24
Hide Description Brachial artery reactivity assessed by noninvasively measuring brachial artery diameter and flow velocities in response to overinflated blood pressure cuff (Flow mediated dilation (FMD))in subjects switching to atazanavir and in subjects continuing on a stable antiretroviral regimen
Time Frame Baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atazanavir Switch Control (Continue Protease Inhibitor)
Hide Arm/Group Description:

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.

ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
Overall Number of Participants Analyzed 26 23
Median (Inter-Quartile Range)
Unit of Measure: percentage change
-1.14
(-2.24 to 1.63)
0.25
(-1.58 to 1.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atazanavir Switch, Control (Continue Protease Inhibitor)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments 25 subjects per arm will have 80% power to detect a difference between groups in mean FMD change of 2.9%, and 90% power to detect a mean FMD change of 3.4%
Statistical Test of Hypothesis P-Value 0.601
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.384
Confidence Interval (2-Sided) 95%
-2.080 to 1.312
Parameter Dispersion
Type: Standard Deviation
Value: 1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Total Cholesterol Levels From Baseline to Week 24
Hide Description Total cholesterol level changes within and between arms
Time Frame Baseline to 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atazanavir Switch Control (Continue Protease Inhibitor)
Hide Arm/Group Description:

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.

ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
Overall Number of Participants Analyzed 26 23
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
-25
(-46 to -14)
2
(-25 to 31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atazanavir Switch, Control (Continue Protease Inhibitor)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.009
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Changes in LDL Particle Number From Baseline to Week 24
Hide Description Change in LDL particle number
Time Frame Baseline to 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atazanavir Switch Control (Continue Protease Inhibitor)
Hide Arm/Group Description:

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.

ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
Overall Number of Participants Analyzed 26 23
Median (Inter-Quartile Range)
Unit of Measure: nmol/l
-194
(-387 to 26)
-116
(-335 to 84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atazanavir Switch, Control (Continue Protease Inhibitor)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.141
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atazanavir Switch Control (Continue Protease Inhibitor)
Hide Arm/Group Description

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.

ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
All-Cause Mortality
Atazanavir Switch Control (Continue Protease Inhibitor)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Atazanavir Switch Control (Continue Protease Inhibitor)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atazanavir Switch Control (Continue Protease Inhibitor)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/24 (0.00%) 
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.
Results Point of Contact
Name/Title: Robert Murphy
Organization: Northwestern University
Phone: 312-503-9000
Responsible Party: Robert L. Murphy, Northwestern University
ClinicalTrials.gov Identifier: NCT00225017     History of Changes
Other Study ID Numbers: SABAR
First Submitted: September 21, 2005
First Posted: September 23, 2005
Results First Submitted: October 4, 2010
Results First Posted: August 2, 2012
Last Update Posted: August 2, 2012