NCT00122226

MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (planned)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections
• HIV-Associated Lipodystrophy Syndrome

Interventions

Type	Name	Description
DRUG	Lopinavir/ritonavir + zidovudine + lamivudine
DRUG	Lopinavir/ritonavir + nevirapine

Timeline

• Start date: 2003-01-01
• Completion: 2008-07-01
• First posted: 2005-07-21
• Last updated: 2006-04-25

Locations

13 sites across 4 countries: Finland, Netherlands, Spain, United Kingdom