Contact information
Type
Scientific
Primary contact
Dr J.N. Vermeulen
ORCID ID
Contact details
Academic Medical Center
T0-111
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5668992
j.n.vermeulen@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00120419
Protocol/serial number
NTR428
Study information
Scientific title
Acronym
MAN2
Study hypothesis
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.
Ethics approval
Received from local medical ethics committee
Study design
Multicentre randomised open label active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
HIV
Intervention
Patients will be randomized (1:1) to mycofenolate mofetil (MMF) 500 mg BID versus no treatment.
The secondary sponsor for this trial is:
National AIDS Therapy Evaluation Centre (NATEC) (Netherlands)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Change over time (baselineweek 48) in CD4+ T cell count and peripheral blood lymphocyte (PBMC) activation markers.
Secondary outcome measures
1. Changes over time (baselineweek 48) in plasma HIV-1 RNA
2. Time to reach indication to start ART - separated in three groups:
2.1. Two consecutive measurements of CD4+ T cell count below 250 x 10^6 cells/l with at least 4 weeks interval
2.2. The occurrence of a CDC class B or C event
2.3. Any other reason
3. Safety data
Overall trial start date
01/03/2005
Overall trial end date
01/03/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patient is ≥18 years of age
2. 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)
3. Patient is HIV-1 treatment naive
4. CD4+ T lymphocyte count >250 and ≤450 x 10^6/l
5. No signs or history of AIDS defining events
6. No use of other medications that might possibly influence the effects of MMF
7. Male or female sex and willingness to practice effective contraception during the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
90
Participant exclusion criteria
1. Plasma HIV-1 RNA <10,000 copies/ml
2. Autoimmune disease
3. Active hepatitis B or C virus infection
4. Other chronic diseases
5. Recent infectious disease other than HIV-1
6. Treatment with immunomodulatory or anti-inflammatory medication in the past 6 months
7. For female patients: pregnancy and lactation
8. 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
Recruitment start date
01/03/2005
Recruitment end date
01/03/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center
Amsterdam
1105 AZ
Netherlands
Funders
Funder type
Other
Funder name
Private fund that does not wish to be named
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary