The Connie Wofsy Womens' HIV Study

Investigator: Ruth Greenblatt, MD
Sponsor: NIH National Institute of Allergy and Infectious Disease

Location(s): United States


This application for the Northern California WIHS site (the Connie Wofsy Women's HIV Study -- CWWHS) is divided into three sections. The first section reports the contributions of our site to the WIHS progress, including cohort and sub study recruitment and retention, scientific leadership, and contributions to organizational leadership. This section contain several standardized tables (the numbers were provided by WDMAC) as well as a table summarizing the activities at our site. The second section provides methods for the research proposed for WIHS III (scientific rationale discussed in Part A). This section provides methods for retention of participants, incorporations of WIHS III protocol modifications, site structure and scientific leadership. The third section describes a proposal for a pilot study of hepatic steatosis among the CWWHS participants. This study, proposed by site investigators Phyllis Tien and Carl Grunfeld and two UCSF-based hepatologists, Norah Terrault and Teresa Wright, defines the incidence and prevalence of hepatic steatosis (HS) among HCV-infected women and factors associated with HS, such as obesity, body habitus changes (defined using DXA imaging) and nucleoside analog therapy. This study will also evaluate the accuracy of computerized tomography in detecting HS compared with percutaneous needle biopsy. This pilot project will also provide insight into the feasibility of this kind of intensive sub study in WIHS. The WIHS III will also provide us with the opportunity to work with new UCSF investigators. In addition to those listed above, this proposal introduces Lewis Sheiner and Joseph Guglielmo (clinical pharmacologists) into the treatment exposure and resistance team and Robert Taylor (reproductive endocrinologist) to the new WIHS initiative on sex steroids. Overall, we are delighted to have this opportunity to propose continued work with the WIHS cohort, which we believe can provide unique and important findings on a representative group of HIV -infected and at-risk women in the United States.