Metabolic Effects of Switching Kaletra to Boosted Reyataz

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To study the effects of switching from Kaletra to Boosted Reyataz on glucose, lipids and fat in HIV-infected patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate; Lopinavir; Ritonavir

Criteria

Inclusion Criteria:

1. Previously diagnosed HIV infection

2. Age between 18-65 years

3. Stable antiviral regimen containing at least 2 nucleoside reverse transcriptase inhibitors (NRTI's) and LPV/r for ³ 6 mos

4. CD4 count > 400 cell/mm3

5. 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 Criteria:

1. Hemoglobin < 11.0 g/dL

2. History of Diabetes Mellitus

3. Currently on medication for Diabetes

4. Therapy with glucocorticoid, growth hormone or other anabolic agents currently or within the past 3 months

5. Current substance abuse, including alcohol, cocaine and/or heroin

6. Any contraindication to ATV/r or known allergy to ATV

7. 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

8. New or serious opportunistic infection in the past 3 months

9. Pregnancy