Clinical Trial: MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)

Brief Summary: This is a randomized prospective study into metabolic adverse events during different types of initial antiretroviral therapy in HIV-1-infected men.

Detailed Summary: This is a randomized prospective study into metabolic adverse events during initial antiretroviral therapy in HIV-1-infected men. The following regimens are compared: lopinavir-ritonavir + Combivir and lopinavir-ritonavir + nevirapine (nucleoside reverse transcriptase inhibitor [NRTI]-sparing). Prior to the start of therapy and 3, 12, 24, and 36 months thereafter the distribution of body fat and bone density (bioelectrical impedance analysis [BIA], computed tomography [CT] and dual energy x-ray absorptiometry [DEXA]), lipid spectrum, mitochondrial DNA (peripheral blood mononuclear cells [PBMCs] and adipose tissue biopsies) and vascular measurements are performed. In addition, insulin sensitivity is measured in a subgroup of sixteen individuals by using a hyperinsulinemic euglycemic clamp and performing microvascular measurements. The aim of the study is to obtain prospective insight into the occurrence of various aspects of metabolic adverse events on the one hand and to compare an NRTI-containing therapy with an NRTI-sparing therapy on the other hand. The hypothesis is that in the NRTI-sparing arm, less metabolic and vascular changes are observed than in the NRTI containing regimen.
Sponsor: VU University Medical Center

Current Primary Outcome:

  • insulin resistance (3, 12, 24, 36 months)
  • microvascular function (3, 12, 24, 36 months)
  • lipid profile (3, 12, 24, 36 months)
  • body composition (3, 12, 24, 36 months)
  • macrovascular function (12, 24, 36 months)


Original Primary Outcome:

  • insulin resistance (3, 24, 36 months)
  • microvascular function (3, 24, 36 months)
  • lipid profile (3, 24, 36 months)
  • body composition (3, 24, 36 months)
  • macrovascular function (24, 36 months)


Current Secondary Outcome:

  • mitochondrial DNA in PBMC and fatty tissue (12, 24, 36 months)
  • gene expression, markers of mitochondrial toxicity, inflammation, apoptosis, fat cell differentiation in fatty tissue (12, 24, 36 months)
  • bone mineral density (12, 24, 36 months)
  • natural killer cells (3, 12, 24 months)


Original Secondary Outcome:

  • mitochondrial DNA in PBMC and fatty tissue (24, 36 months)
  • apoptosis, gene expression fatty tissue (24, 36 months)
  • bone mineral density (24, 36 months)
  • natural killer cells (3, 12, 24 months)


Information By: VU University Medical Center

Dates:
Date Received: July 14, 2005
Date Started: January 2003
Date Completion: July 2008
Last Updated: April 24, 2006
Last Verified: July 2005