Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413153
Status:
COMPLETED
Last Update Posted:
2010-03-09
First Post:
2006-12-15
Brief Title:
Metabolic Effects of Switching Kaletra to Boosted Reyataz
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Metabolic Effects of Switching Kaletra to Boosted Reyataz
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To study the effects of switching from Kaletra to Boosted Reyataz on glucose lipids and fat in HIV-infected patients
Detailed Description:
The primary objective of this study is to determine tissue specific glucose trafficking in patients before and after switching from a regimen containing Lopinavirritonavir LPVr to one containing atazanavirritonavir ATVr Secondary outcome measures of interest will include insulin sensitivity determined by clamp testing and lipid metabolism and hepatic glucose production assessed using stable isotope techniques We hypothesize that switching protease inhibitor PI to ATVr from LPVr will result in direct increases in glucose uptake in muscle and visceral adipose tissue in association with improvements in overall whole body insulin sensitivity compared to remaining on LPVr We will complete a prospective randomized trial of Human Immunodeficiency Virus HIV infected patients who have been on a stable antiretroviral ARV regimen containing LPVr for at least 6 months and who will be randomized to either switch to a regimen containing ATVr or remain on LPVr for 6 months Each subject will complete Positron Emission Tomography PET 18-fluorodeoxyglucose FDG imaging during a hyperinsulinemic clamp study at baseline and 6 months after randomization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None