HIV-1 infection
Conditions
Interventions
Patients will be randomized (1:1) to mycofenol mofetil (MMF) 500 mg BID versus no treatment.
Sponsors
AMC-NATEC
Eligibility
Inclusion criteria
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 naïve; CD4+ T lymphocyte count > 250 and <= 450 * 106/L; 4. No signs or history of AIDS defining events; 5. No use of other medications that might possibly influence the effects of MMF; 6. Male; or female sex and willingness to practice effective contraception during the study.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endpoints: Primary endpoints are change over time (baseline – week 48) in CD4+ T cell count and peripheral blood lymphocyte (PBMC) activation markers. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactJ.N. Vermeulen
Academic Medical Center (AMC), T0-111, P.O. Box 22660
Outcome results
None listed