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AzTrials

HIV InfectionPhase 4NCT00120419

Mycophenolate Mofetil in Antiretroviral Naïve Patients 2 (MAN2 Study)

A Phase 4 study testing mycophenol mofetil (MMF, Cellcept®) 500 mg BID in people with HIV Infection, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 5 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infection
What is being tested?
mycophenol mofetil (MMF, Cellcept®) 500 mg BID
How many people
90 participants
Where
5 sitesNetherlands
Study dates
Apr 2005to not given
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country.

Joost N Vermeulen, MD contact

+31 20 5668992

j.n.vermeulen@amc.uva.nl

Jan M Prins, MD PhD contact

+31 20 5669111

j.m.prins@amc.uva.nl

5 sites in 1 country

Netherlands5 sites, 5 recruiting

  • OLVG

    Amsterdam, North Holland, 1091AC

    Lucie Schrijnders-Gudde, +31 20 5999111 ext. 4626, L.Schrijnders-Gudde@olvg.nl

    Kees Brinkman, MD PhD

    Not yet recruiting

  • Academic Medical Center

    Amsterdam, North Holland, 1105 AZ

    Joost N Vermeulen, MD, +31 20 5668992, j.n.vermeulen@amc.uva.nl

    Jan M Prins, MD PhD, +31 20 566 9111, j.m.prins@amc.uva.nl

    Recruiting

  • Kennemer Gasthuis, location EG

    Haarlem, North Holland, 2035RC

    Robin Soetekouw, MD, +31 23 5453545, soetekou@KG.NL

    Robin Soetekouw, MD

    Not yet recruiting

  • Erasmus Medical Center

    Rotterdam, South Holland, 3015GD

    Iman Padmos, +31 (0)10-4635737, i.padmos@erasmusmc.nl

    Ineke van der Ende, MD PhD

    Recruiting

  • HAGA hospital, location Leyenburg Hospital

    The Hague, South Holland, 2545 CH

    Robert H Kauffmann, MD PhD, +31 70-3592007, r.kauffmann@leyenburg-ziekenhuis.nl

    Anneke van IJperen, +31 70-3592414, j.maat@leyenburg-ziekenhuis.nl

    Not yet recruiting

Other trials in Netherlands

About this study

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.

Read the 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.

Conditions
HIV Infection
Being tested
mycophenol mofetil (MMF, Cellcept®) 500 mg BID
Keywords
HIV-1 infection, immunomodulatory therapy, Treatment Naive
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mycophenol mofetil (MMF, Cellcept®) 500 mg BIDDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change over time (baseline - week 48) in CD4+ cell counts in peripheral blood and peripheral blood lymphocyte activation markers.

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2005 (estimated)
  2. Study startApr 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00120419
Sponsor's protocol ID
MAN2-study
Status last verified
Jan 2006
First submitted
11 Jul 2005
Last updated
22 Jul 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 10888924

  • 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.

    PubMed 15353978

  • 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.

    PubMed 15213566

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing mycophenol mofetil (MMF, Cellcept®) 500 mg BID in people with HIV Infection, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 5 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Joost N Vermeulen, MD (+31 20 5668992, j.n.vermeulen@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change over time (baseline - week 48) in CD4+ cell counts in peripheral blood and peripheral blood lymphocyte activation markers.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00120419, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2009.

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