Women and Trials in High-Income Settings: Clinical Investigator Perspective

Judith S. Currier, MDUniversity 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