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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
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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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  
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 ]

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
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Time Frame 6 month study period
Additional Description All subjects had physical examinations and were queried about any adverse event at each study visit (baseline, 2 weeks, 1 month, 2 months, 4 months, and 6 months), and bilirubin, ALT, ALT, CD4+ count, and HIV ultrasensitive viral load were sent at all of these timepoints.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    Boosted Reyataz (ATV/r)     Continue Kaletra (LPV/r)  
Total, other (not including serious) adverse events      
# participants affected / at risk     6/7     1/8  
Gastrointestinal disorders      
hyperbilirubinemia † 1    
# participants affected / at risk     6/7 (85.71%)     0/8 (0.00%)  
transaminitis † 1 [3]    
# participants affected / at risk     1/7 (14.29%)     0/8 (0.00%)  
Infections and infestations      
HIV RNA Copy Number Increased † 1    
# participants affected / at risk     1/7 (14.29%)     0/8 (0.00%)  
Metabolism and nutrition disorders      
Type 2 Diabetes Mellitus † 1    
# participants affected / at risk     0/7 (0.00%)     1/8 (12.50%)  
Skin and subcutaneous tissue disorders      
cellulitis † 1    
# participants affected / at risk     1/7 (14.29%)     0/8 (0.00%)  
rash † 1    
# participants affected / at risk     1/7 (14.29%)     0/8 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA
[3] ALT and/or AST elevated to any degree above the upper limit of normal.



  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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