Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247494
Status:
UNKNOWN
Last Update Posted:
2009-07-22
First Post:
2005-11-01
Brief Title:
Effects of Mycophenolate Mofetil MMF on Surrogate Markers for Cardiovascular Disease in HIV-1 Infected Patients
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Effects of Mycophenolate Mofetil MMF on Surrogate Markers for Cardiovascular Disease in HIV-1 Infected Patients
Status:
UNKNOWN
Status Verified Date:
2005-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a substudy of the MAN2 -study Mycophenol mofetil in Antiretroviral Naïve patients 2 see elsewhere in the ClinicalTrialsgov database In the MAN2 study HIV-1 infected patients who are not treated with antiretroviral treatment will be randomized to treatment with Mycophenol mofetil MMF500 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
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
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 ClinicalTrialsgov 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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None