MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by VU University Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Abbott
Boehringer Ingelheim
Information provided by:
VU University Medical Center
ClinicalTrials.gov Identifier:
NCT00122226
First received: July 14, 2005
Last updated: April 24, 2006
Last verified: July 2005

July 14, 2005
April 24, 2006
January 2003
Not Provided
  • 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)
  • 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)
Complete list of historical versions of study NCT00122226 on ClinicalTrials.gov Archive Site
  • 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)
  • 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)
Not Provided
Not Provided
 
MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)
MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
  • HIV Infections
  • HIV-Associated Lipodystrophy Syndrome
  • Drug: Lopinavir/ritonavir + zidovudine + lamivudine
  • Drug: Lopinavir/ritonavir + nevirapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
July 2008
Not Provided

Inclusion Criteria:

  • Male
  • Age between 18 and 70 years.
  • No prior use of antiretroviral therapy
  • Indication for antiretroviral treatment according to common standards

Exclusion Criteria:

  • Female sex
  • Body mass index (kg/m2) > 35.
  • Known history of diabetes mellitus or hyperlipidemia
  • Use of coenzyme A reductase inhibitor or fibric acid derivative in the last 6 weeks before inclusion
  • Use of the following medication: systemic corticosteroids, thiazide diuretics, calcium-entry blockers, angiotensin-converting inhibitors, nitrates
  • Use of nandrolone or testosterone
  • Any disorder or condition which can be expected to lead to lessened compliance with the study protocol.
Male
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland,   Netherlands,   Spain,   United Kingdom
 
NCT00122226
protocol 02-72
Not Provided
Not Provided
VU University Medical Center
  • Abbott
  • Boehringer Ingelheim
Principal Investigator: S. A. Danner, MD, PhD Free University Medical Center
Principal Investigator: P. Reiss, MD, PhD Academic Medical Center, National AIDS Therapy Evaluation Centre
VU University Medical Center
July 2005

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