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Mycophenolate Mofetil in Antiretroviral Naïve Patients 2 (MAN2 Study)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2006 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00120419
First Posted: July 18, 2005
Last Update Posted: July 22, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hoffmann-La Roche
Sanquin Research & Blood Bank Divisions
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  Purpose
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.

Condition Intervention Phase
HIV Infection Drug: mycophenol mofetil (MMF, Cellcept®) 500 mg BID Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Change over time (baseline - week 48) in CD4+ cell counts in peripheral blood and peripheral blood lymphocyte activation markers.

Secondary Outcome Measures:
  • * Change over time (baseline - week 48) in plasma HIV-1 RNA, time to reach an indication to start antiretroviral treatment and safety parameters.

Estimated Enrollment: 90
Study Start Date: April 2005
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 * 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is ≥ 18 years of age;
  • 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:

  • Plasma HIV-1 RNA < 10.000 copies/ mL;
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120419


Contacts
Contact: Joost N Vermeulen, MD +31 20 5668992 j.n.vermeulen@amc.uva.nl
Contact: Jan M Prins, MD PhD +31 20 5669111 j.m.prins@amc.uva.nl

Locations
Netherlands
OLVG Not yet recruiting
Amsterdam, NH, Netherlands, 1091AC
Contact: Lucie Schrijnders-Gudde    +31 20 5999111 ext 4626    L.Schrijnders-Gudde@olvg.nl   
Principal Investigator: Kees Brinkman, MD PhD         
Sub-Investigator: H. M. Weigel, MD         
Sub-Investigator: P. H. Frissen, MD PhD         
Sub-Investigator: W. E. Schouten, MD PhD         
Academic Medical Center Recruiting
Amsterdam, NH, Netherlands, 1105 AZ
Contact: Joost N Vermeulen, MD    +31 20 5668992    j.n.vermeulen@amc.uva.nl   
Contact: Jan M Prins, MD PhD    +31 20 566 9111    j.m.prins@amc.uva.nl   
Principal Investigator: Jan M Prins, MD PhD         
Sub-Investigator: Joost N Vermeulen, MD         
Kennemer Gasthuis, location EG Not yet recruiting
Haarlem, NH, Netherlands, 2035RC
Contact: Robin Soetekouw, MD    +31 23 5453545    soetekou@KG.NL   
Principal Investigator: Robin Soetekouw, MD         
Erasmus Medical Center Recruiting
Rotterdam, ZH, Netherlands, 3015GD
Contact: Iman Padmos    +31 (0)10-4635737    i.padmos@erasmusmc.nl   
Principal Investigator: Ineke van der Ende, MD PhD         
HAGA hospital, location Leyenburg Hospital Not yet recruiting
The Hague, ZH, Netherlands, 2545 CH
Contact: Robert H Kauffmann, MD PhD    +31 70-3592007    r.kauffmann@leyenburg-ziekenhuis.nl   
Contact: Anneke van IJperen    +31 70-3592414    j.maat@leyenburg-ziekenhuis.nl   
Principal Investigator: Robert H Kauffman, MD PhD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Hoffmann-La Roche
Sanquin Research & Blood Bank Divisions
Investigators
Principal Investigator: 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
Principal Investigator: Kees Brinkman, MD PhD department of internal medicine, OLVG hospital, Amsterdam, the Netherlands
Principal Investigator: Robin Soetekouw, MD department of internal medicine, Kennemer Gasthuis, Haarlem, the Netherlands
Principal Investigator: Robert Kauffmann, MD PhD Department of Internal Medicine, HAGA hospital, location Leyenburg Hospital, The Hague, The Netherlands
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00120419     History of Changes
Other Study ID Numbers: MAN2-study
First Submitted: July 11, 2005
First Posted: July 18, 2005
Last Update Posted: July 22, 2009
Last Verified: January 2006

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
HIV-1 infection
immunomodulatory therapy
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action