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Metabolic Effects of Switching Kaletra to Boosted Reyataz

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00413153
First received: December 15, 2006
Last updated: March 5, 2010
Last verified: March 2010

December 15, 2006
March 5, 2010
May 2006
December 2008   (final data collection date for primary outcome measure)
Glucose Trafficking [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Glucose trafficking
Complete list of historical versions of study NCT00413153 on ClinicalTrials.gov Archive Site
  • Insulin Sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    6 month mean and standard deviation for insulin-stimulated glucose uptake (M) per unit insulin at 120 minutes as measured by euglycemic hyperinsulinemic clamp.
  • Fasting Glucose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    6 month mean and standard deviation for fasting glucose.
  • Lipid Metabolism - Serum Triglyceride [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    6 month mean and standard deviation for serum triglyceride.
  • Body Composition - Visceral Adipose Tissue [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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).
  • Immune Parameters -- CD4 Count [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    6 month mean and standard deviation for CD4+ count.
  • Liver Enzymes -- Aspartate Aminotransferase (AST) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    6 month mean and standard deviation for AST.
  • Liver Enzymes -- Alanine Aminotransferase (ALT) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    6 month mean and standard deviation for ALT.
  • Total Bilirubin [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    6 month mean and standard deviation for total bilirubin.
  • Insulin sensitivity
  • Lipid metabolism
  • Hepatic glucose production
  • Body Composition
  • Immune parameters
  • Liver enzymes
Not Provided
Not Provided
 
Metabolic Effects of Switching Kaletra to Boosted Reyataz
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: atazanavir/ritonavir
    atazanavir 300mg + ritonavir 100mg once daily
    Other Name: Boosted Reyataz
  • Drug: lopinavir/ritonavir
    patient remains on their pre-study dose of lopinavir/ritonavir
    Other Name: Kaletra
  • Active Comparator: 1
    Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
    Intervention: Drug: atazanavir/ritonavir
  • Active Comparator: 2
    Kaletra (pre-study dose)
    Intervention: Drug: lopinavir/ritonavir
Stanley TL, Joy T, Hadigan CM, Liebau JG, Makimura H, Chen CY, Thomas BJ, Weise SB, Robbins GK, Grinspoon SK. Effects of switching from lopinavir/ritonavir to atazanavir/ritonavir on muscle glucose uptake and visceral fat in HIV-infected patients. AIDS. 2009 Jul 17;23(11):1349-57.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00413153
2005-P-002239
No
Steven K. Grinspoon, MD, Massachusetts General Hospital
Massachusetts General Hospital
Bristol-Myers Squibb
Principal Investigator: Steven K Grinspoon, MD MGH
Massachusetts General Hospital
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP