CLINICAL CORE: The Clinical Core will recruit and follow all the subjects for the four projects that composethis P01 grant. The Clinical Core will build on a very successful research program on early HIV infection, theUCSF Options Project, which has been led by Dr. Hecht since its inception in 1996 and constitutes anexceptional resource for the proposed studies. The Options Project has also established successful methodsfor recruiting potential source partners of newly infected persons and has identified over 40 partner pairs withconfirmed phylogenetic evidence of linkage. The Clinical core will also incorporate a primary infection cohortin Caxias do Sol, located in southern Brazil, which will provide focused recruitment of recently HIV infectedpersons who can identify potential source partners. This region of Brazil has an HIV infection in which thereis a mixture of similar frequencies of subtype B and C virus, offering a resource for comparing theseimportant HIV subtypes in the research projects. The Clinical Core will be responsible for recruiting andfollowing persons with HIV infection of less than 6 months' duration for this grant. In San Francisco, we aimto enroll 50 persons per year, and 30 potential source partners for initial transmission of HIV. In Caxias doSol, we aim to enroll 25 recently infected persons per year, and 25 potential source partners. Potentialsource partners will be evaluated using phylogenetic sequencing to identify likely source partners. Follow-upwill be performed on subjects who meet key criteria for the projects in this proposal. The core will obtainbiological specimens for the research projects and process and store them as needed. It will also gatherclinical data that will be used by each of the projects, including clinical status, and core laboratory data suchas viral load and CD4 T cell counts. The Clinical Core will leverage UCSF-GIVI Center for AIDS Research(CFAR) resources to provide more specialized laboratory data on participants that will be used acrossprojects, including resistance genotyping (CFAR Core Virology Laboratory) and immunophenotyping foractivation markers (CFAR Core Immunology Laboratory). Specimen processing and cryopreservation atUCSF will be performed by the UCSF-CFAR AIDS Specimen Bank, which has extensive experience inprocessing and storing biological specimens for HIV studies. The Brazil component will build on anestablished infrastructure for HIV related cohort studies, and incorporate expert virology and immunologylabs at the Federal University Medical School in Sao Paulo. The clinical data and biological specimensgenerated by the Clinical Core will also form an important research resource for investigators within andoutside of UCSF.
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