Metabolic Effects of Switching Kaletra to Boosted Reyataz

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Boosted Reyataz (300mg atazanavir + 100mg ritonavir)

Group Type ACTIVE_COMPARATOR

atazanavir/ritonavir

Intervention Type DRUG

atazanavir 300mg + ritonavir 100mg once daily

2

Kaletra (pre-study dose)

Group Type ACTIVE_COMPARATOR

lopinavir/ritonavir

Intervention Type DRUG

patient remains on their pre-study dose of lopinavir/ritonavir

Interventions

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atazanavir/ritonavir

atazanavir 300mg + ritonavir 100mg once daily

Intervention Type DRUG

lopinavir/ritonavir

patient remains on their pre-study dose of lopinavir/ritonavir

Intervention Type DRUG

Other Intervention Names

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Boosted Reyataz Kaletra

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No