NCT00120419|UnknownPhase 4DMC
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Sponsor study identifier
interventional
90
1 country
5
Study Start
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedThe 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
July 11, 2005
Actual (reported)July 18, 2005
Actual (reported)Change over time (baseline - week 48) in CD4+ cell counts in peripheral blood and peripheral blood lymphocyte activation markers.
* Change over time (baseline - week 48) in plasma HIV-1 RNA, time to reach an indication to start antiretroviral treatment and safety parameters.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
OLVG
Amsterdam, North Holland, 1091AC, Netherlands
Academic Medical Center
Amsterdam, North Holland, 1105 AZ, Netherlands
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.
Jan M Prins, MD PhD
Department of Internal Medicine, Division of Infectious Diseases, Tropical Medicine and AIDS, Academic Medical Center, University of Amsterdam, the Netherlands
Kees Brinkman, MD PhD
department of internal medicine, OLVG hospital, Amsterdam, the Netherlands
Robin Soetekouw, MD
department of internal medicine, Kennemer Gasthuis, Haarlem, the Netherlands
Robert Kauffmann, MD PhD
Department of Internal Medicine, HAGA hospital, location Leyenburg Hospital, The Hague, The Netherlands
First Submitted
July 11, 2005
First Posted
July 18, 2005
Study Start
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
July 22, 2009
Record last verified: 2006-01
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Source: ClinicalTrials.gov.
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Source retrieved:
Anti-HIV Medications for People Recently Infected With HIV
Contact the study team to confirm eligibility.
Kennemer Gasthuis, location EG
Haarlem, North Holland, 2035RC, Netherlands
Erasmus Medical Center
Rotterdam, South Holland, 3015GD, Netherlands
HAGA hospital, location Leyenburg Hospital
The Hague, South Holland, 2545 CH, Netherlands
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.