ICAP has been awarded funding from National Institutes of Health (NIH) to participate in a new clinical research study by the “HIV Prevention Trials Network (HPTN)”:http://www.hptn.org/ that will evaluate the safety and acceptability of a new injectable HIV prevention medication, TMC278 LA (long acting), a long acting formulation of the drug Rilpivirine, for use in healthy, HIV-uninfected women.
This two-year study (HPTN 076) will be conducted at four research sites—two in sub-Saharan Africa and two in the United States. The ICAP support site, the “Bronx Prevention Center in New York City”:https://icap.columbia.edu/where-we-work/united-states has been selected to participate and Dr. Jessica Justman, ICAP senior technical director, will lead the study at this site.
Currently, Rilpivirine (TMC278) in pill form is approved by the U.S. Food and Drug Administration for use as part of treatment regimen for HIV-infected patients. This study will utilize the injectable form of the drug, which is currently being considered for both HIV prevention and treatment. The study will recruit 132 sexually active women age 18 to 45 years and participants will receive either an injection of TMC278 LA or a placebo once every eight weeks over a 40 week period. There is great interest in the development of such long-acting drugs for prevention of acquisition of HIV infection in order to overcome challenges entailed with more frequent dosing.
ICAP’s work in the United States focuses on HIV prevention research. As a clinical trials research site within the Columbia University clinical trials unit (CTU), ICAP is currently conducting “six HIV-related research studies”:https://icap.columbia.edu/where-we-work/united-states in an effort to advance HIV prevention and enhance the health of underserved communities most impacted by HIV in the U.S.