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

02645 DO SITE FEASIBILITY STUDIES CONTRIBUTE TO THE PLANNING OF PHASE III MICROBICIDE TRIALS?

Naiker, Shamantha
Nair, G., Ramjee, G.
HIV Prevention Research Unit, Medical Research Council, Durban, South Africa 

Background The high cost of Phase III microbicide trials require careful selection of clinical sites capable of meeting the study end points. The current trend is to conduct site feasibility studies to ascertain site capability, adequate clinical and laboratory infrastructure, trained professional staff, adequate “at risk population”, baseline behavioural characteristics, high HIV prevalence and incidence rates and high retention rates. Objective To describe the challenges and the lessons learnt from the microbicide development program funded feasibility study undertaken at 2 sites in Durban.

Results The sites selected for the studies were research “naïve” hence community entry and education played a crucial role in getting approval and support for developing infrastructure. Enormous amount of time was invested in basic education of HIV/STD, prevention strategies, ethics of research and the role of microbicides to not only the community but service providers at clinics in and around the area. Recruitment of trained staff was a challenge as many lacked clinical trial experience. The study initially targeted women from family health and post-natal clinics. The study generated enormous amount of interest hence recruitment was expanded to the community at large. Study specific development of case report forms was challenging as they were not only expensive but required several amendments after the study was implemented. The HIV prevalence rate in the community is high (>40%) suggesting that we had targeted the right population. The baseline behavioural characteristics were helpful in ascertaining behaviour risk factors and to develop the focus of risk reduction counseling. Retention of participants have not been difficult as the study has a high retention rate (>90%) after one year. Conclusion Sponsors should invest in site feasibility studies as they provide a “trial run” of the Phase III study. These studies provide an opportunity to address problems ranging from community entry to retention rates in preparation for a relatively “trouble free” Phase III implementation.

Ms Shamantha Naiker
02 Kampara de Casa, 530 Mountbatten Drive, Reservoir Hills, Durban, 4091, South Africa
(Telephone) 031 203 4729 (Fax) 031 203 4702 (E-mail) Shamantha Naiker@mrc.ac.za