Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120419
Status:
UNKNOWN
Last Update Posted:
2009-07-22
First Post:
2005-07-11
Brief Title:
Mycophenolate Mofetil in Antiretroviral Naïve Patients 2 MAN2 Study
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2006-01
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:
The purpose of the study is to evaluate whether mycophenolate mofetil MMF can treat the chronic hyperactivation of the immune system and partly prevent the decrease of the CD4 T-cell count in chronically HIV-1 infected patients who are not treated with antiretroviral therapy ART The researchers also want to know what the effect is of treatment with MMF on plasma HIV-1 RNA progression of disease occurrence of AIDS defining events or reaching the indication to start ART and the safety of treatment with MMF in this patient group
Detailed Description:
Background During chronic HIV-1 infection the immune system is chronically hyperactivated This hyperactivation is considered as the main cause of CD4 T-cell loss Furthermore HIV replicates most efficiently in activated CD4 T-cells In this study we try to inhibit the activation of the immune system with mycophenolate mofetil MMF Previous studies in which HIV-1 infected patients have been treated with MMF in addition to antiretroviral treatment ART have not shown any additional effect compared to ART alone In this study MMF will be used without antiretroviral medication
Objectives Primary objective of the study is the evaluation of the effect of MMF on the chronic hyperactivation of the immune system and the decrease of the CD4 T-cell count in chronically HIV-1 infected patients who are not treated with antiretroviral therapy ART Secondary objectives include the evaluation of the effect of MMF on plasma HIV-1 RNA progression of disease reaching of indication to start ART and the safety of treatment with MMF in this patient group
Study Design This is a multi center randomized open-label study in which patients will be randomized to treatment with mycophenolate mofetil MMF 500 mg BID during 48 weeks versus no treatment In a subgroup of 20 patients immunology group the first 20 patients in the AMC hospital Amsterdam the Netherlands a number of additional immunological measurements will be performed
The study duration is 60 weeks 48 weeks of treatments with 1 additional visit 12 weeks after cessation of treatment
Study Population Potential participants are adult chronically HIV-1 infected patients who have never been treated with ART and who according to the present criteria do not need to be treated CD4 T lymphocyte count has to be 250 and 450 106L plasma HIV-1 RNA viral load 10000 copies mL
Intervention Patients will be randomized 11 to mycofenolate mofetil MMF 500 mg BID versus no treatment
Endpoints Primary endpoints are change over time baseline - week 48 in CD4 T cell count and peripheral blood lymphocyte PBMC activation markers
Secondary endpoints are changes over time baseline - week 48 in plasma HIV-1 RNA time to reach indication to start ART separated in three groups 1 two consecutive measurements of CD4 T cell count below 250 106 cells L with at least 4 weeks interval 2 the occurrence of a CDC class B or C event 3 any other reason safety data
Objectives Primary objective of the study is the evaluation of the effect of MMF on the chronic hyperactivation of the immune system and the decrease of the CD4 T-cell count in chronically HIV-1 infected patients who are not treated with antiretroviral therapy ART Secondary objectives include the evaluation of the effect of MMF on plasma HIV-1 RNA progression of disease reaching of indication to start ART and the safety of treatment with MMF in this patient group
Study Design This is a multi center randomized open-label study in which patients will be randomized to treatment with mycophenolate mofetil MMF 500 mg BID during 48 weeks versus no treatment In a subgroup of 20 patients immunology group the first 20 patients in the AMC hospital Amsterdam the Netherlands a number of additional immunological measurements will be performed
The study duration is 60 weeks 48 weeks of treatments with 1 additional visit 12 weeks after cessation of treatment
Study Population Potential participants are adult chronically HIV-1 infected patients who have never been treated with ART and who according to the present criteria do not need to be treated CD4 T lymphocyte count has to be 250 and 450 106L plasma HIV-1 RNA viral load 10000 copies mL
Intervention Patients will be randomized 11 to mycofenolate mofetil MMF 500 mg BID versus no treatment
Endpoints Primary endpoints are change over time baseline - week 48 in CD4 T cell count and peripheral blood lymphocyte PBMC activation markers
Secondary endpoints are changes over time baseline - week 48 in plasma HIV-1 RNA time to reach indication to start ART separated in three groups 1 two consecutive measurements of CD4 T cell count below 250 106 cells L with at least 4 weeks interval 2 the occurrence of a CDC class B or C event 3 any other reason safety data
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