Microbicides 2004 Microbicides 200428-31 March 2004, Hilton London MetropoleThe conference42 million men, women and children worldwide were living with HIV by the end of December 2002 (source: UNAIDS), including five million newly-infected during that year alone. Another 45 million people will become infected between 2002 and 2010, unless the current transmission rates can be vastly reduced. Of the 42 million, 29.4 million live in sub-Saharan Africa and 58% of them are women. Not only are women more susceptible to HIV infection, many are powerless to insist on the use of condoms or other methods of protecting themselves. In this context, and with the knowledge that an effective HIV vaccine is unlikely to be available for several years, the need for an effective topical microbicide grows ever more urgent. 2004 should prove to be a landmark year in the field of microbicide development as the first Phase III trials of novel products are due to start – the next step along the road to making a microbicide available to the millions worldwide in desperate need of protection.The aims of the Microbicides 2004 conference are to:Report novel or innovative work in the microbicides fieldProvide updates on recent microbicides research, divided into three tracks: basic science, clinical science, and behavioural science (including public health and the microbicide marketplace)Provide a forum for the discussion of new developments in microbicide research including ethical, clinical, behavioural and methodological issuesPresent opportunities for knowledge-sharing between microbicide researchers, public-health workers and advocacy organisations.There will be an opening ceremony on the evening of Sunday 28 March at which politicians, policy makers and the international media are expected. The conference will run for a full three days, each of which will contain:Scientific overviews and presentations with plenary sessions, invited lecturers and presentations of original researchWorkshops to review issues unique to microbicides such as trial design and outcome measures, and ethical issues in the clinical trials of microbicidesPoster sessions. Focus on LondonFollowing the successful Microbicides conferences in Washington in 2000 and Antwerp in 2002, March 2004 sees the focus move to London.The venue is the Hilton Metropole Hotel, two minutes by taxi from Paddington station and the Heathrow Express, with a journey time from the airport of 15 minutes. The hotel is in walking distance of Hyde Park and London’s main shopping streets, and close to Imperial College. Accommodation will be available at the venue and other hotels in the vicinity.London in March offers a variety of diversions for out-of-conference relaxation, including sight-seeing and shopping; the arts and the theatre; and pubs, clubs and restaurants to suit every taste. Conference staff will be on hand to help delegates plan their spare time.To book your place or find out more information, e-mail info@microbicides2004.org.uk or telephone the Event Office on +44 (0) 20 7720 4411
Oral: invited speaker Oral: Track A Oral: Track B Oral: Track C Poster: Track A Poster: Track B Poster: Track C Abstract only Authors

02433 ENROLLMENT FAILURES IN HIV+ AND HIV- WOMEN SCREENED FOR 2 PHASE I MICROBICIDE TRIALS: HPTN 049/050

Absalon, Judith
El-Sadr, W; Maslankowski, L; Mayer, K; Hoesley, C; Gai, F; Mâsse, B; Richardson, B; Soto-Torres, L; Justman, J.
For The HPTN 049 and 050 Study Teams

Background: Increasing attention has been focused on the development of vaginal microbicides for the prevention of sexually transmitted infections (STIs) and HIV. Reasons for failed enrollment into microbicide studies among HIV+ and HIV- women are not well described and may assist in defining eligibility criteria in future studies.

Objectives: To identify reasons for failed enrollment among HIV+ and HIV- women screened for two Phase I microbicide studies: HPTN 049 (6% cellulose sulphate) and HPTN 050 (PMPA gel).

Results: Of 267 women who completed screening, 174 (65%) failed enrollment. The most common reasons included having an abnormal pelvic exam (30%) or Pap smear (25%) and evidence of a recent STI (24%). Overall rates of failed enrollment were similar between the 131 HIV+ (64%) and 136 HIV- (66%) women screened. Compared to HIV- women, HIV+ women who failed enrollment more often had an abnormal Pap (29% vs 21%) or a recent STI (29% vs 19%). While abnormal CBC (41% vs 14%) or chemistry (21% vs 7%) tests were more frequent among HIV+ women, grade 3 or 4 laboratory values (enrollment exclusion criteria) were similar. Rates of abnormalities found on pelvic exam did not differ between HIV+ and HIV- women who failed enrollment.

Conclusion: Despite pre-selection through strict eligibility criteria, most screened women failed enrollment. HIV+ women who failed had higher rates of abnormal Paps and evidence of recent STIs compared to HIV- women. Eligibility criteria should be carefully assessed in order to allow for enrollment of larger proportions of screened women. This need for screening of large numbers of women should be strongly considered in the development and implementation of future trials.

Judith Absalon, MD, MPH
Department of Epidemiology, Columbia University, 722 W. 168th Street, Rm 710, NY, NY 10032
(Telephone) 212 342 0533 (Fax) 212 342 1824 (E-mail) ja234@columbia.edu