Mycophenolate mofetil in Antiretroviral Naive patients 2 (MAN2 study)
| ISRCTN | ISRCTN43218409 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43218409 |
| ClinicalTrials.gov number | NCT00120419 |
| Secondary identifying numbers | NTR428 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 30/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J.N. Vermeulen
Scientific
Scientific
Academic Medical Center
T0-111
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 5668992 |
|---|---|
| j.n.vermeulen@amc.uva.nl |
Study information
| Study design | Multicentre randomised open label active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Mycophenolate mofetil in Antiretroviral Naive patients 2 (MAN2 study) |
| Study acronym | MAN2 |
| Study objectives | 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(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/03/2005 |
| Completion date | 01/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 90 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2005 |
| Date of final enrolment | 01/03/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
AMC T0-113
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
"ROR" |
https://ror.org/03t4gr691 |
|---|
Funders
Funder type
Other
Private fund that does not wish to be named
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
30/01/2019: No publications found, verifying results with the principle investigator
