Effects of Mycophenolate Mofetil (MMF) on Surrogate Markers for Cardiovascular Disease in HIV-1 Infected Patients
NCT00247494 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2009-07-22
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.
Conditions
- HIV Infection
- Atherosclerosis
Interventions
- DRUG
-
mycophenol mofetil (MMF, Cellcept®) 500 mg BID
Sponsors & Collaborators
-
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
lead OTHER
Principal Investigators
-
Erik S Stroes, MD PhD · Department of Internal Medicine, Division of Vascular Medicine, Academic Medical Center, University of Amsterdam
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-04-30
Countries
- Netherlands
Study Locations
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