Effects of Mycophenolate Mofetil (MMF) on Surrogate Markers for Cardiovascular Disease in HIV-1 Infected Patients
1 other identifier
interventional
90
1 country
1
Brief Summary
This 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 1, 2005
CompletedFirst Posted
Study publicly available on registry
November 2, 2005
CompletedJuly 22, 2009
November 1, 2005
November 1, 2005
July 21, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (1)
The change (week 0-week 48) within patients in biochemical markers, Flow Mediated Dilation and Intima Media Thickness.
Interventions
Eligibility Criteria
You may qualify if:
- Any patient included in the MAN2-study van enter this substudy (see protocol MAN2 study)
You may not qualify if:
- Any condition, illness or use of medication which according to the investigator is not compatible with the conduct of the substudy or which could interfere with the evaluations required by the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Internal Medicine, Academic Medical Center, University of Amsterdam, The Netherlands
Amsterdam, North Holland, 1105 AZ, Netherlands
Related Publications (3)
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.
PMID: 10878285BACKGROUNDRomero 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.
PMID: 10996347BACKGROUNDGreenstein 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.
PMID: 10839960BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erik S Stroes, MD PhD
Department of Internal Medicine, Division of Vascular Medicine, Academic Medical Center, University of Amsterdam
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 1, 2005
First Posted
November 2, 2005
Study Start
April 1, 2005
Last Updated
July 22, 2009
Record last verified: 2005-11