Mycophenolate Mofetil in Antiretroviral Naïve Patients 2 (MAN2 Study)

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 chronically HIV-1 infected patients who are not treated with antiretroviral therapy (ART). The researchers also want to know what the effect is of treatment with MMF on plasma HIV-1 RNA; progression of disease (occurrence of AIDS defining events or reaching the indication to start ART); and the safety of treatment with MMF in this patient group.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Hoffmann-La Roche; Sanquin Research & Blood Bank Divisions
• Treatments: Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.