Current Clinical trials

The Department of Psychiatry and Behavioral Sciences is conducting a federally funded HIV behavioral intervention research study for women and their partners:

The New Opportunities for Women 2 (NOW 2) Project. The project will address topics related to safer sex, sexual risk reduction, STDs and communication skills. The NOW 2 Project is currently recruiting English-speaking couples, in which one or both individuals must be HIV positive. Participants must be 18 years or older, willing to be tested for STDs, and answer personal questions in a confidential interview. Women and men who participate may each receive compensation of up to $360 for an entire year of participation (this includes attendance at all interviews, examinations and sessions). If interested, please contact Arnetta Phillips or Jackie Gomez, at 305-243-2103, or (aphillips@yahoo.com / jgomez4@med.miami.edu).

 

The AIDS Clinical Research Unit, directed by Margaret Fischl, M.D., is recruiting participants for the following studies:

 • An investigational polyclonal caprine IgG, HRG214, for HIV patients not responding to antiretroviral therapy. HRG214 contains antibodies that targets HIV infected CD4 cells and specific regions on HIV. Laboratory/animal studies suggest these antibodies are capable of killing or disabling HIV and preventing further infection.  Participants must have HIV RNA < 5000 copies/ml and CD4 cells < 200 cells/cmm. The study will evaluate 3 increasing dose of HRG214 in part I and compare HRG214 to optimized antiretroviral therapy in part II. HFG214 is given IV over about 30 minutes three times a week for up to 26 weeks. $100 provided each completed week of HRG214 treatment and $25 each completed week of observation

 • A phase II study of investigation use of recombination human keratinocyte growth factor (rHuKGF, palifermin) for patients with incomplete immune recovery on HAART.  rHuKGF may enhance thymus production of lymphocytes and increase CD4 cell counts. Participants must be 18 years and older, receiving antiretroviral therapy for at least 6 months with HIV RNA <200 and CD4 cell count <200 cells.  The study will evaluate 3 doses (20, 40 60 mcg/kg) of rHuKGF compared to placebo.  rHuKGF given IV bolus daily for 3 days. Follow up study visits at weeks 1,2,4,8, 12 and 24 with thymus CT scans at entry and week 12.

 • A phase II of an investigational glycosylated recombinant human IL-7 (CYT017, a cytokine that aids T-cell development and improves T-cell survival). Participants must be 18 years of age, receiving HAART for at least 12 months and have an HIV-1 RNA level < 1,000 copies/ml and CD4 cell count of 101– 400 cells/ccm. The study will evaluate three increasing doses (10, 20, 30 Fg/kg) of IL-7 given by SQ injection once a week for 3 weeks. Up to $275 in food certificates provided.

For more information on studies conducted by the AIDS Clinical Research Unit, contact Juan at 305-243-3838 or Leslie at L.Thompson@miami.edu.