This trial is active, not recruiting.

Conditions hiv infections, hiv-associated lipodystrophy syndrome
Treatments lopinavir/ritonavir + zidovudine + lamivudine, lopinavir/ritonavir + nevirapine
Phase phase 4
Sponsor VU University Medical Center
Collaborator Abbott
Start date January 2003
End date July 2008
Trial size 50 participants
Trial identifier NCT00122226, protocol 02-72


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacodynamics study
Intervention model parallel assignment
Masking single blind
Primary purpose prevention

Primary Outcomes

insulin resistance (3, 12, 24, 36 months)
time frame:
microvascular function (3, 12, 24, 36 months)
time frame:
lipid profile (3, 12, 24, 36 months)
time frame:
body composition (3, 12, 24, 36 months)
time frame:
macrovascular function (12, 24, 36 months)
time frame:

Secondary Outcomes

mitochondrial DNA in PBMC and fatty tissue (12, 24, 36 months)
time frame:
gene expression, markers of mitochondrial toxicity, inflammation, apoptosis, fat cell differentiation in fatty tissue (12, 24, 36 months)
time frame:
bone mineral density (12, 24, 36 months)
time frame:
natural killer cells (3, 12, 24 months)
time frame:

Eligibility Criteria

Male participants from 18 years up to 70 years old.

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.

Additional Information

Official title MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)
Principal investigator S. A. Danner, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2006.
Information provided to ClinicalTrials.gov by VU University Medical Center.