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Completed

NCT Number: NCT00413153

Metabolic Effects of Switching Kaletra to Boosted Reyataz

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

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Immunologic Deficiency Syndromes Infections Insulin Resistance Lentivirus Infections Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

atazanavir/ritonavir

Drug

atazanavir 300mg + ritonavir 100mg once daily

Other names: Boosted Reyataz

Lopinavir/ritonavir

Drug

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

Other names: Kaletra

Primary outcomes

  1. 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

  1. Insulin Sensitivity

    Time frame: 6 months

    6 month mean and standard deviation for insulin-stimulated glucose uptake (M) per unit insulin at 120 minutes as measured by euglycemic hyperinsulinemic clamp.

  2. Fasting Glucose

    Time frame: 6 months

    6 month mean and standard deviation for fasting glucose.

  3. Lipid Metabolism - Serum Triglyceride

    Time frame: 6 months

    6 month mean and standard deviation for serum triglyceride.

  4. Body Composition - Visceral Adipose Tissue

    Time frame: 6 months

    6 month mean and standard deviation for visceral adipose tissue (VAT) as measured by single slice computed tomography (CT) scan at the L4 pedicle (pedicle of 4th lumbar vertebra).

  5. Immune Parameters -- CD4 Count

    Time frame: 6 months

    6 month mean and standard deviation for CD4+ count.

  6. Liver Enzymes -- Aspartate Aminotransferase (AST)

    Time frame: 6 months

    6 month mean and standard deviation for AST.

  7. Liver Enzymes -- Alanine Aminotransferase (ALT)

    Time frame: 6 months

    6 month mean and standard deviation for ALT.

  8. Total Bilirubin

    Time frame: 6 months

    6 month mean and standard deviation for total bilirubin.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 19, 2006
Registry last updated
Mar 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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