Mycophenolate Mofetil in Antiretroviral Naïve Patients 2 (MAN2 Study)
Recruitment status was Recruiting
|First Received Date ICMJE||July 11, 2005|
|Last Updated Date||July 21, 2009|
|Start Date ICMJE||April 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Change over time (baseline - week 48) in CD4+ cell counts in peripheral blood and peripheral blood lymphocyte activation markers.|
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00120419 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||* Change over time (baseline - week 48) in plasma HIV-1 RNA, time to reach an indication to start antiretroviral treatment and safety parameters.|
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Mycophenolate Mofetil in Antiretroviral Naïve Patients 2 (MAN2 Study)|
|Official Title ICMJE||Not Provided|
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.
*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 * 106/L, plasma HIV-1 RNA (viral load) < 10.000 copies/ mL.
*Intervention: Patients will be randomized (1:1) 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 Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Condition ICMJE||HIV Infection|
|Intervention ICMJE||Drug: mycophenol mofetil (MMF, Cellcept®) 500 mg BID|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||90|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Netherlands|
|NCT Number ICMJE||NCT00120419|
|Other Study ID Numbers ICMJE||MAN2-study|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
|Information Provided By||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
|Verification Date||January 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP