Transcript 200808_jcurrier_en.ppt

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