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

02346_2 EVALUATION OF THE LOCAL TOLERANCE OF VAGINAL FORMULATIONS CONTAINING TMC 120 USING RABBITS AND SLUGS

Dhondt, Marijke*
Adriaens, E.*; Van Roey, J.**; Remon, J.P.*
*Laboratory of Pharmaceutical Technology, Ghent University, Harelbekestraat 72, 9000 Gent, Belgium **Tibotec Bvba, Gen De Wittelaan L 11b3, 2800 Mechelen, Belgium

Vaginal irritation might increase the susceptibility to sexually transmitted pathogens upon sexual intercourse. Therefore, it is important to evaluate the local tolerance of vaginal formulations. Pre-clinical safety studies are often assessed in rabbits. However, there is a tendency to reduce, refine, and replace the use of vertebrates for this purpose.

In this study the local tolerance of a vehicle gel and 3 gels with different concentrations of TMC120 (obtained from Tibotec) was evaluated with the rabbit vaginal irritation (RVI) test and with an alternative mucosal irritation test using slugs. Conceptrol“ was used as positive control. The effect of the gels on the rabbit vaginal mucosa was evaluated after intravaginal treatment for 10 consecutive days by means of microscopical examination of the vagina and cervix. The irritation potency of the gels on the mucosal tissue of the slugs was assessed by the mucus production (caused by a repeated treatment for 5 successive days) and by the protein and enzyme release from the slug mucosa after treatment.

Conceptrol“ caused epithelial loss and atrophy in the rabbits and severe irritation of the slug mucosa (increased mucus production, protein release and enzyme release). The vehicle gel and the TMC120 gels induced no epithelial loss and atrophy in the rabbits and also no irritation of the slug mucosa (low mucus production and protein release, no enzyme release). So both the RVI test and the slug mucosal irritation test showed that the vehicle gel and the TMC120 gels are non-irritating gels.

Pharm. Marijke M. M. Dhondt
Laboratory of Pharmaceutical Technology, Ghent University, Harelbekestraat 72, B-9000 Gent, Belgium
(Telephone) +32 (0)9 264 80 84 (Fax) +32 (0)9 222 82 36 (E-mail) Marijke.Dhondt@UGent.be