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MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)

Primary Purpose

HIV Infections, HIV-Associated Lipodystrophy Syndrome

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Lopinavir/ritonavir + zidovudine + lamivudine
Lopinavir/ritonavir + nevirapine
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, HIV-associated lipodystrophy syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Helsinki University Central Hospital
  • Academic Medical Center
  • Medisch Centrum Jan van Goyen
  • Onze Lieve Vrouwe Gasthuis, location Oosterpark
  • Onze Lieve Vrouwe Gasthuis, location Prinsengracht
  • Slotervaart ziekenhuis
  • VUMC Free University Medical Center
  • Ziekenhuis Leyenburg
  • Kennemer Gasthuis, location Elisabeth
  • Leids Universitair Medisch Centrum
  • Erasmus Universitair Medisch Centrum
  • Hospital Clinic
  • Royal Free Hospital

Outcomes

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)

Full Information

First Posted
July 14, 2005
Last Updated
April 24, 2006
Sponsor
Amsterdam UMC, location VUmc
Collaborators
Abbott, Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00122226
Brief Title
MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)
Official Title
MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Unknown status
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Amsterdam UMC, location VUmc
Collaborators
Abbott, Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HIV-Associated Lipodystrophy Syndrome
Keywords
HIV, HIV-associated lipodystrophy syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lopinavir/ritonavir + zidovudine + lamivudine
Intervention Type
Drug
Intervention Name(s)
Lopinavir/ritonavir + nevirapine
Primary Outcome Measure Information:
Title
insulin resistance (3, 12, 24, 36 months)
Title
microvascular function (3, 12, 24, 36 months)
Title
lipid profile (3, 12, 24, 36 months)
Title
body composition (3, 12, 24, 36 months)
Title
macrovascular function (12, 24, 36 months)
Secondary Outcome Measure Information:
Title
mitochondrial DNA in PBMC and fatty tissue (12, 24, 36 months)
Title
gene expression, markers of mitochondrial toxicity, inflammation, apoptosis, fat cell differentiation in fatty tissue (12, 24, 36 months)
Title
bone mineral density (12, 24, 36 months)
Title
natural killer cells (3, 12, 24 months)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S. A. Danner, MD, PhD
Organizational Affiliation
Free University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
P. Reiss, MD, PhD
Organizational Affiliation
Academic Medical Center, National AIDS Therapy Evaluation Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
Country
Finland
Facility Name
Academic Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
Medisch Centrum Jan van Goyen
City
Amsterdam
Country
Netherlands
Facility Name
Onze Lieve Vrouwe Gasthuis, location Oosterpark
City
Amsterdam
Country
Netherlands
Facility Name
Onze Lieve Vrouwe Gasthuis, location Prinsengracht
City
Amsterdam
Country
Netherlands
Facility Name
Slotervaart ziekenhuis
City
Amsterdam
Country
Netherlands
Facility Name
VUMC Free University Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
Ziekenhuis Leyenburg
City
den Haag
Country
Netherlands
Facility Name
Kennemer Gasthuis, location Elisabeth
City
Haarlem
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
Country
Netherlands
Facility Name
Erasmus Universitair Medisch Centrum
City
Rotterdam
Country
Netherlands
Facility Name
Hospital Clinic
City
Barcelona
Country
Spain
Facility Name
Royal Free Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19898246
Citation
van Vonderen MG, Blumer RM, Hassink EA, Sutinen J, Ackermans MT, van Agtmael MA, Yki-Jarvinen H, Danner SA, Serlie MJ, Sauerwein HP, Reiss P. Insulin sensitivity in multiple pathways is differently affected during zidovudine/lamivudine-containing compared with NRTI-sparing combination antiretroviral therapy. J Acquir Immune Defic Syndr. 2010 Feb;53(2):186-93. doi: 10.1097/QAI.0b013e3181c190f4.
Results Reference
derived
PubMed Identifier
19479079
Citation
van Vonderen MG, van Agtmael MA, Hassink EA, Milinkovic A, Brinkman K, Geerlings SE, Ristola M, van Eeden A, Danner SA, Reiss P; MEDICLAS study group. Zidovudine/lamivudine for HIV-1 infection contributes to limb fat loss. PLoS One. 2009 May 21;4(5):e5647. doi: 10.1371/journal.pone.0005647.
Results Reference
derived
PubMed Identifier
19424051
Citation
van Vonderen MG, Lips P, van Agtmael MA, Hassink EA, Brinkman K, Geerlings SE, Sutinen J, Ristola M, Danner SA, Reiss P. First line zidovudine/lamivudine/lopinavir/ritonavir leads to greater bone loss compared to nevirapine/lopinavir/ritonavir. AIDS. 2009 Jul 17;23(11):1367-76. doi: 10.1097/QAD.0b013e32832c4947.
Results Reference
derived
PubMed Identifier
19275490
Citation
van Vonderen MG, Hassink EA, van Agtmael MA, Stehouwer CD, Danner SA, Reiss P, Smulders Y. Increase in carotid artery intima-media thickness and arterial stiffness but improvement in several markers of endothelial function after initiation of antiretroviral therapy. J Infect Dis. 2009 Apr 15;199(8):1186-94. doi: 10.1086/597475.
Results Reference
derived

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MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)

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