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
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.
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age between 18 and 70 years.
No prior use of antiretroviral therapy
Indication for antiretroviral treatment according to common standards
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.