Mycophenolate Mofetil in Antiretroviral Naïve Patients 2 (MAN2 Study)

NCT00120419 | Unknown Phase 4 DMC

• 1 other identifier: MAN2-study
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

HIV-1 infection; immunomodulatory therapy; Treatment Naive

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

mycophenol mofetil (MMF, Cellcept®) 500 mg BID DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥ 18 years of age;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Hoffmann-La Roche: collaborator
• Sanquin Research & Blood Bank Divisions: collaborator

Study Sites (5)

OLVG

Amsterdam, North Holland, 1091AC, Netherlands

NOT YET RECRUITING

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Kennemer Gasthuis, location EG

Haarlem, North Holland, 2035RC, Netherlands

NOT YET RECRUITING

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

HAGA hospital, location Leyenburg Hospital

The Hague, South Holland, 2545 CH, Netherlands

NOT YET RECRUITING

Related Publications (3)

• 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.

  PMID: 10888924 BACKGROUND

• 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.

  PMID: 15353978 BACKGROUND

• 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.

  PMID: 15213566 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Mycophenolic Acid; BID protein, human

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2005
• First Posted: July 18, 2005
• Study Start: April 1, 2005
• Last Updated: July 22, 2009

Record last verified: 2006-01

Locations

NL (5)