DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Metabolic Effects of Switching Kaletra to Boosted Reyataz

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: atazanavir/ritonavir (Drug); lopinavir/ritonavir (Drug)

Phase: N/A

Status: Completed

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Steven K Grinspoon, MD, Principal Investigator, Affiliation: MGH

Summary

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

Clinical Details

Official title: Metabolic Effects of Switching Kaletra to Boosted Reyataz

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Glucose Trafficking

Secondary outcome:

Insulin Sensitivity

Fasting Glucose

Lipid Metabolism - Serum Triglyceride

Body Composition - Visceral Adipose Tissue

Immune Parameters -- CD4 Count

Liver Enzymes -- Aspartate Aminotransferase (AST)

Liver Enzymes -- Alanine Aminotransferase (ALT)

Total Bilirubin

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 atazanavir/ritonavir (ATV/r). 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 ATV/r from LPV/r 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 LPV/r. We will complete a prospective randomized trial of Human Immunodeficiency Virus (HIV) infected patients who have been on a stable antiretroviral (ARV) regimen containing LPV/r for at least 6 months and who will be randomized to either switch to a regimen containing ATV/r or remain on LPV/r 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information

Starting date: May 2006
Last updated: March 5, 2010

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017