Status:
COMPLETED
Metabolic Effects of Switching Kaletra to Boosted Reyataz
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
NA
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 Lopinavir/ritonavir (LPV/r) to one containing a...
Eligibility Criteria
Inclusion
- Previously diagnosed HIV infection
- Age between 18-65 years
- Stable antiviral regimen containing at least 2 nucleoside reverse transcriptase inhibitors (NRTI's) and LPV/r for ³ 6 mos
- CD4 count \> 400 cell/mm3
- Metabolic complication as indicated by one or more of hyperinsulinemia (fasting insulin \>= 15 mIU/ml), hypercholesteremia (fasting total cholesterol \>= 200 mg/dL), hypertriglyceridemia (fasting triglycerides \>= 150 mg/dL), or treatment with a lipid lowering medication.
Exclusion
- Hemoglobin \< 11.0 g/dL
- History of Diabetes Mellitus
- Currently on medication for Diabetes
- Therapy with glucocorticoid, growth hormone or other anabolic agents currently or within the past 3 months
- Current substance abuse, including alcohol, cocaine and/or heroin
- Any contraindication to ATV/r or known allergy to ATV
- Concurrent therapy with: Bepridil; cisapride; ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine); indinavir; irinotecan; lovastatin; midazolam; pimozide; proton pump inhibitors (esomeprazole, lansoprazole, omeprazole); rifampin; simvastatin; St John's wort; or triazolam
- New or serious opportunistic infection in the past 3 months
- Pregnancy
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00413153
Start Date
May 1 2006
End Date
December 1 2008
Last Update
March 9 2010
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114