Status:
UNKNOWN
Mycophenolate Mofetil in Antiretroviral Naïve Patients 2 (MAN2 Study)
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Hoffmann-La Roche
Sanquin Research & Blood Bank Divisions
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 chr...
Detailed Description
\*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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00120419
Start Date
April 1 2005
Last Update
July 22 2009
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
OLVG
Amsterdam, North Holland, Netherlands, 1091AC
2
Academic Medical Center
Amsterdam, North Holland, Netherlands, 1105 AZ
3
Kennemer Gasthuis, location EG
Haarlem, North Holland, Netherlands, 2035RC
4
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015GD