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

02597 EXPANDED PHASE I SAFETY AND ACCEPTABILITY TRIAL OF 6% CELLULOSE SULPHATE GEL AS A VAGINAL MICROBICIDE

1Malonza, Isaac
2Mirembe F, 2Nakabiito C, 3Odusoga OL, 3Osinupebi OA, 4Kamal H, 4Chitlange S, 1Ali MM, 1Hazelden CN, 1Landoulsi SB, 5Callahan M, 1Farley TMM, 5Van Damme L
1Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland; 2Department of Obstetrics and Gynaecology, Makerere University, Kampala, Uganda; 3Centre for Research in Reproductive Health, Ogun State University Teaching Hospital, Sagamu, Nigeria; 4National Institute for Research in Reproductive Health, Mumbai, India; and 5CONRAD, Arlington, USA.

Background: Sodium cellulose sulphate is a non-cytotoxic polymer with antimicrobial activity in vitro. An expanded Phase I trial was done to assess the safety and acceptability of 6% cellulose sulphate (CS) compared to K-Y® Jelly.

Methods: Sexually abstinent (cohort I) and sexually active (cohort II) women were recruited in India, Nigeria and Uganda. Participants were randomized to twice daily vaginal applications of either 3.5 ml 6% CS or 3.5 ml K-Y® Jelly for seven consecutive days. Safety was determined in cohort I before enrolling cohort II and was assessed by symptoms and signs (including colposcopy) of genital irritation and by changes in vaginal health as assessed by microscopy. Product acceptability was assessed by a structured questionnaire.

Results: One hundred and eighty women (90 on CS and 90 on K-Y® Jelly; equally distributed between centres and cohorts within each centre) were enrolled. Compliance with gel use was 94% overall. Baseline characteristics of women in both gel groups were similar. In cohort I, 6 (14%) women on CS and 12 (27%) on K-Y® Jelly reported genital symptoms, two of whom withdrew from study. New colposcopy findings were detected in 4 (9%) women on CS and 9 (21%) women on K-Y® Jelly in cohort I. Two women on CS and three on K-Y® Jelly in cohort II reported genital symptoms. Five women (11%) in each gel group in cohort II had new colposcopy findings. Differences between gel groups were not statistically significant. Over 80% (151/175) of women had no problem with their product, and 65% found their assigned gel very easy to use.

Conclusion: Twice daily vaginal applications of 6% cellulose sulphate appears to be as safe and well tolerated as K-Y® Jelly. Further studies of the effectiveness of CS to prevent HIV and pregnancy are planned.

Dr Isaac Malonza
20 Avenue Appia, 1211 Geneva 27, Switzerland
(Telephone) 41-22-791-3641 (Fax) 41-22-791-4171 (E-mail) malonzai@who.int