MEDICLAS – Metabolic Effects of Different Classes of Antiretrovirals Study

Principal contacts

Michiel A. van Agtmael - Amsterdam University Medical Centers (location VUMC), Amsterdam, the Netherlands

Marit G. A. van Vonderen - Medical Center Leeuwarden, Leeuwarden, the Netherlands

Peter Reiss - Amsterdam University Medical Centers (location VUMC), Amsterdam, the Netherlands

Study design

The Metabolic Effects of Different Classes of Antiretrovirals Study (MEDICLAS) is a multicentre and multinational two-arm clinical trial based in Helsinki, Amsterdam, den Haag, Haarlem, Leiden, Rotterdam, Barcelona, and London. The principal aim of the trial was to investigate the effect of different combinations of antiretroviral therapy, Lopinavir (400mg/day) or Ritonavir (100mg/day) and Zidovudine (300mg/day) or Lamivudine (150mg/day) versus Lopinavir (533mg/day) or Ritonavir (133mg/day) and Nevirapine (200mg/day) on metabolic and vascular changes in HIV-infected men. Individuals were eligible for inclusion if they were aged between 18 and 70 years with an indication to initiate a combination antiretroviral therapy. The study was approved by the ethics committees of all participating centres. Written informed consent was obtained from all participants before study entry.

Link to study webpage – https://clinicaltrials.gov/ct2/show/NCT00122226

 

Key publications

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

Zidovudine/Lamivudine for HIV-1 Infection Contributes to Limb Fat Loss. PLoS One. 2009 May 21;4(5):e5647

First line zidovudine/lamivudine/lopinavir/ritonavir leads to greater bone loss compared to nevirapine/ lopinavir/ritonavir. AIDS. 2009 Jul 17;23(11):1367-76

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