Mycophenolate Mofetil in Antiretroviral Naïve Patients 2 (MAN2 Study)
Recruitment status was Recruiting
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
- 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.
| Estimated Enrollment: | 90 |
| Study Start Date: | April 2005 |
*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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 |
| Netherlands | |
| 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 | |
| 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 | |
| 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 | |
| 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 |
| Study First Received: | July 11, 2005 |
| Last Updated: | July 21, 2009 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
|
HIV-1 infection immunomodulatory therapy Treatment Naive |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Mycophenolate mofetil Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013