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Metabolic Effects of Switching Kaletra to Boosted Reyataz

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00413153
First Posted: December 19, 2006
Last Update Posted: March 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by:
Massachusetts General Hospital
Results First Submitted: November 4, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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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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
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 
Overall Participants Analyzed 
[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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Measure Type Primary
Measure Title Glucose Trafficking
Measure Description 6 month mean and standard deviation for glucose uptake into anterior thigh muscle as measured by FDG/PET scanning during euglycemic hyperinsulinemic clamp. During the hyperinsulinemic conditions of the clamp, glucose and 18-FDG [labeled glucose] are taken up by muscle. The quantity of 18-FDG taken up is measured by the PET scan. Although there are no well-accepted norms for this measurement, a higher value indicates that more glucose is being taken up by (or "trafficked to") muscle. Increased uptake of glucose indicates increased muscle insulin sensitivity.
Time Frame 6 months  

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.
Only data from subjects with 0 and 6 month Positron Emission Tomography (PET) scans were 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) 
Participants Analyzed 
[Units: Participants]
 5   6 
Glucose Trafficking 
[Units: Umol/kg/min]
Mean (Standard Deviation)
 26.7  (8.1)   24.4  (17.7) 


Statistical Analysis 1 for Glucose Trafficking
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.035
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Initial samples size of N=16 calculated to provide 80% power to detect a 30% change in muscle glucose uptake between groups. Student's t-test used to compare change from baseline and determine treatment effect (net difference over time between the ATV/r vs. LPV/r groups).
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



2.  Secondary:   Insulin Sensitivity   [ Time Frame: 6 months ]

3.  Secondary:   Fasting Glucose   [ Time Frame: 6 months ]

4.  Secondary:   Lipid Metabolism - Serum Triglyceride   [ Time Frame: 6 months ]

5.  Secondary:   Body Composition - Visceral Adipose Tissue   [ Time Frame: 6 months ]

6.  Secondary:   Immune Parameters -- CD4 Count   [ Time Frame: 6 months ]

7.  Secondary:   Liver Enzymes -- Aspartate Aminotransferase (AST)   [ Time Frame: 6 months ]

8.  Secondary:   Liver Enzymes -- Alanine Aminotransferase (ALT)   [ Time Frame: 6 months ]

9.  Secondary:   Total Bilirubin   [ Time Frame: 6 months ]


  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