- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00247494
Effects of Mycophenolate Mofetil (MMF) on Surrogate Markers for Cardiovascular Disease in HIV-1 Infected Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- background Immune activation plays an important role in atherogenesis. In HIV-1 infection, the immune system is chronically hyperactivated. There also seems to be an increased incidence of cardiovascular disease in untreated HIV-1 infection. Mycophenol mofetil (MMF) will be used to treat this immune activation in untreated HIV-1 infected patients in the MAN2-study (see elsewhere in this ClinicalTrials.gov database).
- Hypothesis T-cell inhibition with MMF attenuates T-cell number, T-cell activation and T-cell - monocyte interaction, thereby minimizing the T-cell-driven inflammatory amplification loop.
In addition, MMF reduces expression of adhesion molecules on endothelial cells and leucocytes, thereby attenuating recruitment of circulating leucocytes to the atherosclerotic plaque. Combining these effects MMF treatment will improve anti-atherogenic defence mechanisms, such as improvement of endothelial function and attenuation of the pro-inflammatory state.
*design This will be a substudy of of the multi-center, double-blind, randomized, trial "Mycophenol mofetil in Antiretroviral Naïve patients 2 (MAN2 study)" (called the main study hereafter). The aim of the substudy is to evaluate the effects of mycophenolate mofetil on ´surrogate markers´ for atherosclerosis in a group of HIV-1 infected patients. All 90 patients to be included in the main study will be asked to participate in this substudy. A separate informed consent is needed.
Patients participating in this substudy will undergo study procedures for the substudy only on day 0 and week 48 of the main study (i.e. before the first dose of MMF and after 48 weeks of MMF treatment for the patients randomized to MMF treatment). Extra blood will be drawn to measure several biochemical markers associated with atherosclerosis and will be measured. Furthermore measurements of the condition of the blood vessels will be performed (using ultrasound, amongst others).
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Sander I. van Leuven, MD
- Phone Number: +31 20 5668675
- Email: s.i.vanleuven@amc.uva.nl
Study Locations
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NH
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Amsterdam, NH, Netherlands, 1105 AZ
- Recruiting
- Department of Internal Medicine, Academic Medical Center, University of Amsterdam, The Netherlands
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Contact:
- Sander I van Leuven, MD
- Phone Number: +31 20 5668675
- Email: s.i.vanleuven@amc.uva.nl
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Sub-Investigator:
- Sander I van Leuven, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Any patient included in the MAN2-study van enter this substudy (see protocol MAN2 study)
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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The change (week 0-week 48) within patients in biochemical markers, Flow Mediated Dilation and Intima Media Thickness.
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Collaborators and Investigators
Investigators
- Principal Investigator: Erik S Stroes, MD PhD, Department of Internal Medicine, Division of Vascular Medicine, Academic Medical Center, University of Amsterdam
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Cardiovascular Diseases
- Atherosclerosis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antitubercular Agents
- Antibiotics, Antitubercular
- Mycophenolic Acid
Other Study ID Numbers
- Myocardh
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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