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
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)

Resource links provided by NLM:


Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • 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)

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 50
Study Start Date: January 2003
Estimated Study Completion Date: July 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122226

Locations
Finland
Helsinki University Central Hospital
Helsinki, Finland
Netherlands
VUMC Free University Medical Center
Amsterdam, Netherlands
Slotervaart ziekenhuis
Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis, location Prinsengracht
Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis, location Oosterpark
Amsterdam, Netherlands
Academic Medical Center
Amsterdam, Netherlands
Medisch Centrum Jan van Goyen
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

No publications provided by VU University Medical Center

Additional 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
Study First Received: July 14, 2005
Last Updated: April 24, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
HIV-Associated Lipodystrophy Syndrome
Lipodystrophy
Syndrome
Disease
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Lipid Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Skin Diseases
Skin Diseases, Metabolic
Slow Virus Diseases
Virus Diseases
Lopinavir
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 30, 2014