drugset / Trial / NCT00122226
MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)
Phase 4
Unknown
50 enrolled
Amsterdam UMC, location VUmc
Abbott · collabBoehringer Ingelheim · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
This is a randomized prospective study into metabolic adverse events during different types of initial antiretroviral therapy in HIV-1-infected men.
Timeline
- Start
- 2003-01
- Primary completion
- —
- Completion
- 2008-07
Publications
- van Vonderen MG, Blumer RM, Hassink EA, Sutinen J, Ackermans MT, van Agtmael MA, Yki-Jarvinen H, Danner SA, Serlie MJ, Sauerwein HP, Reiss P. 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. doi: 10.1097/QAI.0b013e3181c190f4.
- van Vonderen MG, van Agtmael MA, Hassink EA, Milinkovic A, Brinkman K, Geerlings SE, Ristola M, van Eeden A, Danner SA, Reiss P; MEDICLAS study group. Zidovudine/lamivudine for HIV-1 infection contributes to limb fat loss. PLoS One. 2009 May 21;4(5):e5647. doi: 10.1371/journal.pone.0005647.
- van Vonderen MG, Lips P, van Agtmael MA, Hassink EA, Brinkman K, Geerlings SE, Sutinen J, Ristola M, Danner SA, Reiss P. First line zidovudine/lamivudine/lopinavir/ritonavir leads to greater bone loss compared to nevirapine/lopinavir/ritonavir. AIDS. 2009 Jul 17;23(11):1367-76. doi: 10.1097/QAD.0b013e32832c4947.
- van Vonderen MG, Hassink EA, van Agtmael MA, Stehouwer CD, Danner SA, Reiss P, Smulders Y. 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. doi: 10.1086/597475.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lamivudine | Other / unclassified | — | — |
| Subject | Lopinavir | Other / unclassified | 400 mg | — |
| Subject | Lopinavir | Other / unclassified | 533 mg | — |
| Subject | Nevirapine | Small molecule | — | — |
| Subject | Ritonavir | Other / unclassified | 100 mg | — |
| Subject | Ritonavir | Other / unclassified | 133 mg | — |
| Subject | Zidovudine | Small molecule | — | — |