---
title: Metabolic Effects of Switching Kaletra to Boosted Reyataz
nct_id: NCT00413153
overall_status: COMPLETED
phase: NA
sponsor: Massachusetts General Hospital
study_type: INTERVENTIONAL
primary_condition: HIV Infections
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00413153.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00413153"
ct_last_update_post_date: 2010-03-09
last_seen_at: "2026-05-12T06:25:46.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Metabolic Effects of Switching Kaletra to Boosted Reyataz

**NCT ID:** [NCT00413153](https://clinicaltrials.gov/study/NCT00413153)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 15
- **Lead Sponsor:** Massachusetts General Hospital
- **Collaborators:** Bristol-Myers Squibb
- **Conditions:** HIV Infections
- **Start Date:** 2006-05
- **Completion Date:** 2008-12
- **CT.gov Last Update:** 2010-03-09

## Brief Summary

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

## 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
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **1** (ACTIVE_COMPARATOR) — Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
- **2** (ACTIVE_COMPARATOR) — Kaletra (pre-study dose)

## Interventions

- **atazanavir/ritonavir** (DRUG) — atazanavir 300mg + ritonavir 100mg once daily
- **lopinavir/ritonavir** (DRUG) — patient remains on their pre-study dose of lopinavir/ritonavir

## Primary Outcomes

- **Glucose Trafficking** _(time frame: 6 months)_ — 6 month mean and standard deviation for glucose uptake into anterior thigh muscle as measured by FDG/PET scanning during euglycemic hyperinsulinemic clamp. During the hyperinsulinemic conditions of the clamp, glucose and 18-FDG \[labeled glucose\] are taken up by muscle. The quantity of 18-FDG taken up is measured by the PET scan. Although there are no well-accepted norms for this measurement, a higher value indicates that more glucose is being taken up by (or "trafficked to") muscle. Increased uptake of glucose indicates increased muscle insulin sensitivity.

## Secondary Outcomes

- **Insulin Sensitivity** _(time frame: 6 months)_
- **Fasting Glucose** _(time frame: 6 months)_
- **Lipid Metabolism - Serum Triglyceride** _(time frame: 6 months)_
- **Body Composition - Visceral Adipose Tissue** _(time frame: 6 months)_
- **Immune Parameters -- CD4 Count** _(time frame: 6 months)_
- **Liver Enzymes -- Aspartate Aminotransferase (AST)** _(time frame: 6 months)_
- **Liver Enzymes -- Alanine Aminotransferase (ALT)** _(time frame: 6 months)_
- **Total Bilirubin** _(time frame: 6 months)_

## Locations (1)

- Massachusetts General Hospital, Boston, Massachusetts, United States

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.massachusetts general hospital|boston|massachusetts|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00413153.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00413153*  
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