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MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)

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ClinicalTrials.gov Identifier: NCT00122226
Recruitment Status : Unknown
Verified July 2005 by Amsterdam UMC, location VUmc.
Recruitment status was:  Active, not recruiting
First Posted : July 21, 2005
Last Update Posted : April 25, 2006
Sponsor:
Collaborators:
Abbott
Boehringer Ingelheim
Information provided by:
Amsterdam UMC, location VUmc

Tracking Information
First Submitted Date  ICMJE July 14, 2005
First Posted Date  ICMJE July 21, 2005
Last Update Posted Date April 25, 2006
Study Start Date  ICMJE January 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2006)
  • 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 Measures  ICMJE
 (submitted: July 14, 2005)
  • 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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2006)
  • 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 Measures  ICMJE
 (submitted: July 14, 2005)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)
Official Title  ICMJE 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 Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Condition  ICMJE
  • HIV Infections
  • HIV-Associated Lipodystrophy Syndrome
Intervention  ICMJE
  • Drug: Lopinavir/ritonavir + zidovudine + lamivudine
  • Drug: Lopinavir/ritonavir + nevirapine
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: July 14, 2005)
50
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE July 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland,   Netherlands,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00122226
Other Study ID Numbers  ICMJE protocol 02-72
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Amsterdam UMC, location VUmc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Abbott
  • Boehringer Ingelheim
Investigators  ICMJE
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
PRS Account Amsterdam UMC, location VUmc
Verification Date July 2005

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