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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 VU University Medical Center.
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:
VU University Medical Center

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

Condition or disease Intervention/treatment Phase
HIV Infections HIV-Associated Lipodystrophy Syndrome Drug: Lopinavir/ritonavir + zidovudine + lamivudine Drug: Lopinavir/ritonavir + nevirapine Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)
Study Start Date : January 2003
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. insulin resistance (3, 12, 24, 36 months)
  2. microvascular function (3, 12, 24, 36 months)
  3. lipid profile (3, 12, 24, 36 months)
  4. body composition (3, 12, 24, 36 months)
  5. macrovascular function (12, 24, 36 months)

Secondary Outcome Measures :
  1. mitochondrial DNA in PBMC and fatty tissue (12, 24, 36 months)
  2. gene expression, markers of mitochondrial toxicity, inflammation, apoptosis, fat cell differentiation in fatty tissue (12, 24, 36 months)
  3. bone mineral density (12, 24, 36 months)
  4. natural killer cells (3, 12, 24 months)

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122226


Locations
Finland
Helsinki University Central Hospital
Helsinki, Finland
Netherlands
Academic Medical Center
Amsterdam, Netherlands
Medisch Centrum Jan van Goyen
Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis, location Oosterpark
Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis, location Prinsengracht
Amsterdam, Netherlands
Slotervaart ziekenhuis
Amsterdam, Netherlands
VUMC Free University Medical Center
Amsterdam, Netherlands
Ziekenhuis Leyenburg
den Haag, Netherlands
Kennemer Gasthuis, location Elisabeth
Haarlem, Netherlands
Leids Universitair Medisch Centrum
Leiden, Netherlands
Erasmus Universitair Medisch Centrum
Rotterdam, Netherlands
Spain
Hospital Clinic
Barcelona, Spain
United Kingdom
Royal Free Hospital
London, United Kingdom
Sponsors and Collaborators
VU University Medical Center
Abbott
Boehringer Ingelheim
Investigators
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00122226     History of Changes
Other Study ID Numbers: protocol 02-72
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: April 25, 2006
Last Verified: July 2005

Keywords provided by VU University Medical Center:
HIV
HIV-associated lipodystrophy syndrome

Additional relevant MeSH terms:
HIV Infections
Lipodystrophy
HIV-Associated Lipodystrophy Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
 Ritonavir
Lopinavir
Lamivudine
Zidovudine
Nevirapine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors