Women and Trials in High-Income Settings: Clinical Investigator Perspective Judith S. Currier, MD University of California, Los Angeles

History of Enrollment of Women into ART Trials: High Resource  Women have been under represented in most ART trials - the proportion of women in trials has lagged behind proportion of women living with HIV  Most pronounced early in the epidemic  Focus on women was primarily in studies of PMTCT  Slow improvement seen in the late 1990s as trial sites expanded and more women entered care  Remains an important issue for studies in treatment experienced patients  Many recent naïve studies have enrolled ~30% women  Most studies of new agents in experienced patients enroll < 20% women

Interest in Sex-specific data  Early findings of sex-specific outcomes highlighted the need to place a greater focus on enrollment of women and on generating data on women for new drugs  Lactic acidosis and nucleosides  Rash and hepatotoxicity with nevirapine Link between sex, CD4 and nevirapine hepatotoxicity

Barriers to Enrollment in Trials Mirrors Barriers to Care  Poverty  Unemployment=no insurance  Competing health and family needs  Inconvenient hours and locations of clinics  Transportation  Childcare  Isolation and fear of disclosure

New Barriers  Naïve Trials  Availability of simple, safer treatment options outside of trials

What is changing  Increased peer advocacy for more data in women  Peer support and education around treatment and participation in clinical trials  Websites dedicated to women and HIV  Launching of women specific ART trials in non-pregnant women by Industry ( GRACE study 70% women)  Community involvement in research agenda and trial design  Barrier’s acknowledged and being addressed at clinical trial sites  Added costs to recruit and enroll women- yield benefits  Expansion of clinical trial sites to community based settings

What is still needed?  Research to optimize treatment for women over the lifecycle  Need to integrate questions of women’s health into studies where HIV transmission is primary endpoint  Optimal ART in Pregnancy  Optimal management of ART post-partum  Need for expanded data on safety of ART in pregnancy with currently limited formulary  Pregnancy Registry  Aging and ART for women

Future Goals  Maintain and strengthen partnerships between women living with HIV, governmental agencies, NGO, industry and clinical investigators  Prioritize research questions  Coordinate research efforts  Disseminate new data that is being generated