Sponsor study identifier
interventional
90
1 country
1
Study Start
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedThis study is a substudy of the MAN2 -study (Mycophenol mofetil in Antiretroviral Naïve patients 2, see elsewhere in the ClinicalTrials.gov database). In the MAN2 study, HIV-1 infected patients who are not treated with antiretroviral treatment will be randomized to treatment with Mycophenol mofetil (MMF)500 mg BID or a control group without treatment (open label). Both patients randomized to treatment with MMF and patients randomized to the control group will be asked to participate also in this substudy. In this substudy we want to show whether monotherapy with Mycophenol mofetil (MMF) in patients infected with HIV-1 can reduce acceleration of atherogenesis by attenuating various inflammatory pathways normally involved in progression of atherosclerosis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
November 1, 2005
Actual (reported)November 2, 2005
Actual (reported)The difference between the two groups (patients treated with MMF and the control group without treatment) in the change (week 0-week 48) in biochemical markers, Flow Mediated Dilation and Intima Media Thickness.
The change (week 0-week 48) within patients in biochemical markers, Flow Mediated Dilation and Intima Media Thickness.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Internal Medicine, Academic Medical Center, University of Amsterdam, The Netherlands
Amsterdam, North Holland, 1105 AZ, Netherlands
Allison AC, Eugui EM. Mycophenolate mofetil and its mechanisms of action. Immunopharmacology. 2000 May;47(2-3):85-118. doi: 10.1016/s0162-3109(00)00188-0.
Romero F, Rodriguez-Iturbe B, Pons H, Parra G, Quiroz Y, Rincon J, Gonzalez L. Mycophenolate mofetil treatment reduces cholesterol-induced atherosclerosis in the rabbit. Atherosclerosis. 2000 Sep;152(1):127-33. doi: 10.1016/s0021-9150(99)00458-x.
Erik S Stroes, MD PhD
Department of Internal Medicine, Division of Vascular Medicine, Academic Medical Center, University of Amsterdam
First Submitted
November 1, 2005
First Posted
November 2, 2005
Study Start
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
July 22, 2009
Record last verified: 2005-11
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Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved:
BASIC: Boosted Atazanavir or Saquinavir Induced Lipid Changes
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Greenstein SM, Sun S, Calderon TM, Kim DY, Schreiber TC, Schechner RS, Tellis VA, Berman JW. Mycophenolate mofetil treatment reduces atherosclerosis in the cholesterol-fed rabbit. J Surg Res. 2000 Jun 15;91(2):123-9. doi: 10.1006/jsre.2000.5919.