Effects of Mycophenolate Mofetil (MMF) on Surrogate Markers for Cardiovascular Disease in HIV-1 Infected Patients

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Treatments: Mycophenolate mofetil; Mycophenolic Acid

Criteria

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.