The Brown University/Lifespan Adult Therapeutic Clinical Trials Application for AIDS Research brings together clinicians and researchers with expertise in clinical trials with a strong record in specific issues regarding HIV-infected women and """"""""hard to reach populations"""""""". This is an unaffiliated clinical trials application. We plan to enroll 60 new patients per year for the first two years, and 40 patients per year for each year thereafter, and maintain enrollees in long term follow-up (up to four years). Sixty percent of enrollees will be women and a major focus will be the long term evaluation of HIV expression and shedding in different compartments, particularly the genital tract. In addition, this site has a well established program for the integration of HIV care for incarcerated individuals into continuing post-release health care in the community. This experience will be brought to bear on the enrollment and follow- up of incarcerated individuals into controlled clinical trials. In particular, investigators on the grant, Doctors Timothy Flanigan, Susan Cu Uvin, Charles Carpenter, Ken Mayer, and Karen Tashima have an extensive background of long-term clinical studies focused on HIV and women. This expertise can be brought to a larger clinical trials network in order to expand and focus an agenda regarding HIV and women. This well integrated clinical site has an established record of working in close collaboration with investigators at Massachusetts General Hospital (MGH) in order to explore virologic expression and development of resistance in the genital tract and the CSF. This clinical site will be able to contribute to the agenda of long term viral suppression in all compartments utilizing combination therapies, particularly among women and hard to reach populations.
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