Metabolic Effects of Switching Kaletra to Boosted Reyataz

Mass General Brigham

Status: Completed

Conditions: HIV Infections

Treatments: Drug: lopinavir/ritonavir; Drug: atazanavir/ritonavir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00413153

2005-P-002239

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

15 participants in 2 patient groups

1

Active Comparator group

Description:

Boosted Reyataz (300mg atazanavir + 100mg ritonavir)

Treatment:

Drug: atazanavir/ritonavir

2

Active Comparator group

Description:

Kaletra (pre-study dose)

Treatment:

Drug: lopinavir/ritonavir