Metabolic Effects of Switching Kaletra to Boosted Reyataz
Completed · Not applicable
Conditions studied: HIV Infections
In brief
To study the effects of switching from Kaletra to Boosted Reyataz on glucose, lipids and fat in HIV-infected patients.
Key facts
- Study ID
- NCT00413153
- Run by
- Massachusetts General Hospital
- People needed
- 15
- Starts
- 2006-05-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2010-03-09
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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