MedDataX Logo

MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)

NCT ID: NCT00122226

Last Updated: 2006-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2008-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections HIV-Associated Lipodystrophy Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

HIV HIV-associated lipodystrophy syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lopinavir/ritonavir + zidovudine + lamivudine

Intervention Type DRUG

Lopinavir/ritonavir + nevirapine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

S. A. Danner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Free University Medical Center

P. Reiss, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Academic Medical Center, National AIDS Therapy Evaluation Centre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Helsinki University Central Hospital

Helsinki, , Finland

Site Status

Academic Medical Center

Amsterdam, , Netherlands

Site Status

Medisch Centrum Jan van Goyen

Amsterdam, , Netherlands

Site Status

Onze Lieve Vrouwe Gasthuis, location Oosterpark

Amsterdam, , Netherlands

Site Status

Onze Lieve Vrouwe Gasthuis, location Prinsengracht

Amsterdam, , Netherlands

Site Status

Slotervaart ziekenhuis

Amsterdam, , Netherlands

Site Status

VUMC Free University Medical Center

Amsterdam, , Netherlands

Site Status

Kennemer Gasthuis, location Elisabeth

Haarlem, , Netherlands

Site Status

Leids Universitair Medisch Centrum

Leiden, , Netherlands

Site Status

Erasmus Universitair Medisch Centrum

Rotterdam, , Netherlands

Site Status

Ziekenhuis Leyenburg

The Hague, , Netherlands

Site Status

Hospital Clinic

Barcelona, , Spain

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland Netherlands Spain United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 19898246 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19479079 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19424051 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19275490 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

protocol 02-72

Identifier Type: -

Identifier Source: org_study_id