MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 14, 2005

Last Updated Date

April 24, 2006

Start Date ^ICMJE

January 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

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

Complete list of historical versions of study NCT00122226 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention

Condition ^ICMJE

HIV Infections
HIV-Associated Lipodystrophy Syndrome

Intervention ^ICMJE

Drug: Lopinavir/ritonavir + zidovudine + lamivudine
Drug: Lopinavir/ritonavir + nevirapine

Study Arms

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

Estimated Completion Date

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

Sexes Eligible for Study:

Male

Ages

18 Years to 70 Years (Adult, Senior)

Accepts Healthy Volunteers

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

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

VU University Medical Center

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

VU University Medical Center

Verification Date

July 2005

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

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