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Metabolic Effects of Switching Kaletra to Boosted Reyataz

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00413153
First received: December 15, 2006
Last updated: March 5, 2010
Last verified: March 2010
History of Changes
Results First Received: November 4, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: atazanavir/ritonavir
Drug: lopinavir/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
Subjects were recruited through information given to HIV-care providers, postings in HIV-community organizations, newspaper advertisements, and the Massachusetts General Hospital research patient data registry. Recruitment began in March, 2006, and continued through May, 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After screening visit to determine eligibility, subjects were asked to continue their current antiretroviral medications until the baseline visit, immediately after which they were randomized to continue lopinavir/ritonavir or switch to atazanavir/ritonavir.

Reporting Groups
  Description
Boosted Reyataz (ATV/r) Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
Continue Kaletra (LPV/r) Kaletra (pre-study dose)

Participant Flow:   Overall Study
    Boosted Reyataz (ATV/r)     Continue Kaletra (LPV/r)  
STARTED     7     8  
COMPLETED     5     7  
NOT COMPLETED     2     1  
Withdrawal by Subject                 1                 1  
Adverse Event                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Boosted Reyataz (ATV/r) Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
Continue Kaletra (LPV/r) Kaletra (pre-study dose)
Total Total of all reporting groups

Baseline Measures
    Boosted Reyataz (ATV/r)     Continue Kaletra (LPV/r)     Total  
Number of Participants  
[units: participants]
 		  7     8     15  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     7     8     15  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  46  ± 8     50  ± 6     48  ± 7  
Gender  
[units: participants]
 		     
Female     2     1     3  
Male     5     7     12  
Region of Enrollment  
[units: participants]
 		     
United States     7     8     15  



  Outcome Measures
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1.  Primary:   Glucose Trafficking   [ Time Frame: 6 months ]
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2.  Secondary:   Insulin Sensitivity   [ Time Frame: 6 months ]
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3.  Secondary:   Fasting Glucose   [ Time Frame: 6 months ]
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4.  Secondary:   Lipid Metabolism - Serum Triglyceride   [ Time Frame: 6 months ]
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5.  Secondary:   Body Composition - Visceral Adipose Tissue   [ Time Frame: 6 months ]
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Measure Type Secondary
Measure Title Body Composition - Visceral Adipose Tissue
Measure Description 6 month mean and standard deviation for visceral adipose tissue (VAT) as measured by single slice computed tomography (CT) scan at the L4 pedicle (pedicle of 4th lumbar vertebra).
Time Frame 6 months  
Safety Issue No  

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.
Data from participants with 0 & 6 month data analyzed.

Reporting Groups
  Description
Boosted Reyataz (ATV/r) Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
Continue Kaletra (LPV/r) Kaletra (pre-study dose)

Measured Values
    Boosted Reyataz (ATV/r)     Continue Kaletra (LPV/r)  
Number of Participants Analyzed  
[units: participants]
 		  5     7  
Body Composition - Visceral Adipose Tissue  
[units: square centimeters]
Mean ± Standard Deviation 		  91  ± 34     167  ± 61  


Statistical Analysis 1 for Body Composition - Visceral Adipose Tissue
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] 0.047
[1] Additional details about the analysis, such as null hypothesis and power calculation:
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[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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6.  Secondary:   Immune Parameters -- CD4 Count   [ Time Frame: 6 months ]
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7.  Secondary:   Liver Enzymes -- Aspartate Aminotransferase (AST)   [ Time Frame: 6 months ]
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8.  Secondary:   Liver Enzymes -- Alanine Aminotransferase (ALT)   [ Time Frame: 6 months ]
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9.  Secondary:   Total Bilirubin   [ Time Frame: 6 months ]
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  Serious Adverse Events
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  Other Adverse Events
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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 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.
unchecked Other disclosure agreement that restricts the right of the PI 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: Steven K. Grinspoon, MD
Organization: Massachusetts General Hospital
phone: 617-724-9109
e-mail: sgrinspoon@partners.org


No publications provided by Massachusetts General Hospital

Publications automatically indexed to this study:


Responsible Party: Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00413153     History of Changes
Other Study ID Numbers: 2005-P-002239
Study First Received: December 15, 2006
Results First Received: November 4, 2009
Last Updated: March 5, 2010
Health Authority: United States: Institutional Review Board