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

02092_1 AN OPEN PHASE 1 TRIAL OF 13% CELLULOSE ACETATE PHTHALATE (CAP) VAGINAL MICROBICIDE.

Sawant Sangeeta
Miranda Cowen, Nicola Kaganson, Andrew Nunn, Sheena Mccormack, Robert Neurath, Charles Lacey
MRC/DFID Microbicide Development programme (MDP)

Background
Cellulose acetate phthalate (CAP) is a widely used pharmaceutical excipients that has been shown to block HIV-1 infection. In vitro studies confirmed that interaction between HIV-1 and CAP led to rapid virus adsorption onto CAP, gp41 six-helix bundle formation, virus disintegration and shedding of envelope glycoprotein with rapid loss of infectivity. In vivo experiments using animal models confirmed CAP is non- toxic, non-mutagenic and non-teratogenic. A new gel formulation for use as a vaginal microbicide has been developed.

Methods
A phase 1 vaginal microbicide safety study has been approved by the local research ethics committee. 60 women will be recruited. The study will be conducted in 2 parts. Informed consent will be obtained from women who meet the entry criteria. Part A will study 10 HIV-ve volunteers using CAP once a day for 14 days and will include a post-first dose Colposcopic assessment. The DSMC will review safety data from part A before proceeding to part B. Then 40 HIV-ve (randomised to gel, n=30 or observation, n=10) and 10 HIV+ve women (all will receive gel) will be recruited in Part B of the study. Outcome parameters will include local vaginal, clinical and laboratory adverse events.

Results
Enrolling 50 women in CAP arm enables to estimate the incidence of clinically significant adverse events. Thus if one person experiences such an event the 95% CI for the estimate will be 0.05% -10.6%
Discussion
Our study will provide the first human CAP vaginal microbicide safety data.

Dr Sangeeta Sawant
Clinical Trials Centre, Winston Churchill Wing, St Marys Hospital Campus, Imperial College London, Norfolk Place, London W2 1PG
(Telephone) 020 7886 6738 (Fax) 020 7886 6123 (E-mail) ssawant@imperial.ac.uk