Mycophenolate Mofetil in Antiretroviral Naïve Patients 2 (MAN2 Study)
NCT ID: NCT00120419
Last Updated: 2009-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
90 participants
INTERVENTIONAL
2005-04-30
Brief Summary
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Detailed Description
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\*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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
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mycophenol mofetil (MMF, Cellcept®) 500 mg BID
Eligibility Criteria
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Inclusion Criteria
* Patient has a proven HIV-1 infection (with antibodies against HIV-1 and a detectable plasma HIV-1 RNA measured for the first time at least 6 months prior to inclusion);
* Patient is HIV-1 treatment naïve;
* CD4+ T lymphocyte count \> 250 and \<= 450 \* 106/L;
* No signs or history of AIDS defining events;
* No use of other medications that might possibly influence the effects of MMF;
* Male; or female sex and willingness to practice effective contraception during the study.
Exclusion Criteria
* Autoimmune disease;
* Active hepatitis B or C virus infection;
* Other chronic diseases;
* Recent infectious disease other than HIV-1;
* Treatment with immunomodulatory or anti-inflammatory medication in the past 6 months;
* For female patients: pregnancy and lactation;
* Any other condition, illness or use of medication which according to the investigator is not compatible with the use of the study medication or which could interfere with the evaluations required by the study.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Sanquin Research & Blood Bank Divisions
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Principal Investigators
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Jan M Prins, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine, Division of Infectious Diseases, Tropical Medicine and AIDS, Academic Medical Center, University of Amsterdam, the Netherlands
Kees Brinkman, MD PhD
Role: PRINCIPAL_INVESTIGATOR
department of internal medicine, OLVG hospital, Amsterdam, the Netherlands
Robin Soetekouw, MD
Role: PRINCIPAL_INVESTIGATOR
department of internal medicine, Kennemer Gasthuis, Haarlem, the Netherlands
Robert Kauffmann, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine, HAGA hospital, location Leyenburg Hospital, The Hague, The Netherlands
Locations
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OLVG
Amsterdam, North Holland, Netherlands
Academic Medical Center
Amsterdam, North Holland, Netherlands
Kennemer Gasthuis, location EG
Haarlem, North Holland, Netherlands
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
HAGA hospital, location Leyenburg Hospital
The Hague, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Chapuis AG, Paolo Rizzardi G, D'Agostino C, Attinger A, Knabenhans C, Fleury S, Acha-Orbea H, Pantaleo G. Effects of mycophenolic acid on human immunodeficiency virus infection in vitro and in vivo. Nat Med. 2000 Jul;6(7):762-8. doi: 10.1038/77489.
Sankatsing SU, Jurriaans S, van Swieten P, van Leth F, Cornelissen M, Miedema F, Lange JM, Schuitemaker H, Prins JM. Highly active antiretroviral therapy with or without mycophenolate mofetil in treatment-naive HIV-1 patients. AIDS. 2004 Sep 24;18(14):1925-31. doi: 10.1097/00002030-200409240-00008.
Garcia F, Plana M, Arnedo M, Brunet M, Castro P, Gil C, Vidal E, Millan O, Lopez A, Martorell J, Fumero E, Miro JM, Alcami J, Pumarola T, Gallart T, Gatell JM. Effect of mycophenolate mofetil on immune response and plasma and lymphatic tissue viral load during and after interruption of highly active antiretroviral therapy for patients with chronic HIV infection: a randomized pilot study. J Acquir Immune Defic Syndr. 2004 Jul 1;36(3):823-30. doi: 10.1097/00126334-200407010-00009.
Other Identifiers
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MAN2-study
Identifier Type: -
Identifier Source: org_study_id
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