| |
Protocol Number:
05-I-0065
- Title:
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effect of Leflunomide on HIV-1 Associated Immune Proliferation In Vivo
- Number:
05-I-0065
- 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.
- Sponsoring Institute:
-
National Institute of Allergy and Infectious Diseases (NIAID)
- Recruitment Detail
- Type:
Completed Study; data analyses ongoing
- Gender:
Male & Female
- Referral Letter Required:
No
- Population Exclusion(s):
Children
- Eligibility Criteria:
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Special Instructions:
Currently Not Provided
- Keyword(s):
-
Immunomodulatory Drug
-
Antiviral
-
Ki67+
-
Immune Activation
-
T Cell Proliferation
-
HIV
-
Activated CD4+T-cell
-
Proliferation
- Recruitment Keyword(s):
-
HIV
- Condition(s):
-
HIV Infections
- Investigational Drug(s):
-
Leflunomide
- Investigational Device(s):
- None
- Interventions:
-
Drug: Leflunomide
- Supporting Site:
-
National Institute of Allergy and Infectious Diseases
- Contact(s):
-
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Citation(s):
-
Grossman Z, CD4+ T-cell depletion in HIV infection: are we closer to understanding the cause? Nat Med. 2002 Apr;8(4):319-23.
-
McCune JM. The dynamics of CD4+ T-cell depletion in HIV disease. Nature. 2001 Apr 19;410(6831):974-9.
-
Sousa AE, CD4 T cell depletion is linked directly to immune activation in the pathogenesis of HIV-1 and HIV-2 but only indirectly to the viral load. J Immunol. 2002 Sep15;169(6):3400-6.
If you have:
Search The Studies | Help | Questions |
Clinical Center Home | NIH Home
 National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/13/2009
|
|
