Metabolic Effects of Switching Kaletra to Boosted Reyataz
|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.|
|ClinicalTrials.gov Identifier: NCT00413153|
Recruitment Status : Completed
First Posted : December 19, 2006
Results First Posted : March 3, 2010
Last Update Posted : March 9, 2010
|Condition or disease||Intervention/treatment|
|HIV Infections||Drug: atazanavir/ritonavir Drug: lopinavir/ritonavir|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metabolic Effects of Switching Kaletra to Boosted Reyataz|
|Study Start Date :||May 2006|
|Primary Completion Date :||December 2008|
|Study Completion Date :||December 2008|
Active Comparator: 1
Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
atazanavir 300mg + ritonavir 100mg once daily
Other Name: Boosted Reyataz
Active Comparator: 2
Kaletra (pre-study dose)
patient remains on their pre-study dose of lopinavir/ritonavir
Other Name: Kaletra
- Glucose Trafficking [ Time Frame: 6 months ]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.
- Insulin Sensitivity [ Time Frame: 6 months ]6 month mean and standard deviation for insulin-stimulated glucose uptake (M) per unit insulin at 120 minutes as measured by euglycemic hyperinsulinemic clamp.
- Fasting Glucose [ Time Frame: 6 months ]6 month mean and standard deviation for fasting glucose.
- Lipid Metabolism - Serum Triglyceride [ Time Frame: 6 months ]6 month mean and standard deviation for serum triglyceride.
- Body Composition - Visceral Adipose Tissue [ Time Frame: 6 months ]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).
- Immune Parameters -- CD4 Count [ Time Frame: 6 months ]6 month mean and standard deviation for CD4+ count.
- Liver Enzymes -- Aspartate Aminotransferase (AST) [ Time Frame: 6 months ]6 month mean and standard deviation for AST.
- Liver Enzymes -- Alanine Aminotransferase (ALT) [ Time Frame: 6 months ]6 month mean and standard deviation for ALT.
- Total Bilirubin [ Time Frame: 6 months ]6 month mean and standard deviation for total bilirubin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413153
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Steven K Grinspoon, MD||MGH|