Condition category
Infections and Infestations
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
17/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 (baseline–week 48) in CD4+ T cell count and peripheral blood lymphocyte (PBMC) activation markers.

Secondary outcome measures

1. Changes over time (baseline–week 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

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

AMC T0-113
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes