MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)

Amsterdam UMC, location VUmc

Status and phase

Unknown

Phase 4

Conditions

HIV-Associated Lipodystrophy Syndrome

HIV Infections

Treatments

Drug: Lopinavir/ritonavir + nevirapine

Drug: Lopinavir/ritonavir + zidovudine + lamivudine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00122226

protocol 02-72

Details and patient eligibility

About

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

Full 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.

Sex

Male

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.