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Mycophenolate Mofetil in Antiretroviral Naïve Patients 2 (MAN2 Study)

NCT00120419 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2009-07-22

No results posted yet for this study

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). 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.

Conditions

  • HIV Infection

Interventions

DRUG

mycophenol mofetil (MMF, Cellcept®) 500 mg BID

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Sanquin Research & Blood Bank Divisions

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • 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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00120419 on ClinicalTrials.gov