Effect of Leflunomide on T Cell Proliferation in HIV-Infected Patients
Status:
Completed
Trial end date:
2008-05-21
Target enrollment:
Participant gender:
Summary
This study will evaluate the effect of leflunomide on the life cycle of a specific immune
cell called CD4+ T cell in HIV-infected patients. Leflunomide is approved by the Food and
Drug Administration for treating rheumatoid arthritis. It works by blocking cell division in
activated T cells. In HIV infection, the HIV virus causes increased activation of T cells.
The activated cells become infected and die. Activation may also cause the death of T cells
that are not infected with HIV. T cells are necessary for the body to fight infections and
cancer. This study will see if leflunomide can block T-cell division and possibly reduce the
number of cells that die, reduce the number of cells in which HIV can reproduce, and lead to
a lower level of HIV virus in the body.
HIV-infected patients between 18 and 65 years of age who have 1) HIV viral levels of 1,000
copies/mL or more, 2) a CD4+ T-cell count of 350 cells/mm3 or more, and 3) a CD4+ T-cell
count that has never been less than 200 cells/mm3 may be eligible for this study. Candidates
are screened with a medical history, physical examination, blood and urine tests, chest
x-ray, and electrocardiogram (EKG).
Participants are randomly assigned to take leflunomide or placebo (a substance with no active
ingredient) every day for 28 days. They come to the clinic three times during the first 29
days of the study (days 1, 15, and 29) for a physical examination and review of any drug side
effects. Patients taking placebo end their participation on day 29. Patients taking
leflunomide stop taking the drug on day 29 and begin taking cholestyramine three times a day
for 11 days out of the next 14 days to clear the leflunomide from their body. On day 43, they
return to the clinic to have their leflunomide level checked to make sure that only very
little or none of the drug remains in the body. If the level is low, patients end their
participation on or around day 57. If the level remains high, they repeat the cholestyramine
treatment.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)