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

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

Outcome Measures

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)

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
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

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

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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

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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

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

van Vonderen MG, Blümer 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.

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.

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.

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.

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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:

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HIV-Associated Lipodystrophy Syndrome Lipodystrophy HIV Infections 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

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