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

02674 REACHING CONSENSUS: DEVELOPING AN AGREED CLINICAL TRIAL PROTOCOL FOR A MULTI-CENTRE MICROBICIDE RCT

Mc Cormack, Sheena*
Kaganson N*, Hayes R**, Nunn A* and the Clinical Trial Working Group of The Microbicides Development Programme (MDP)
MRC CTU*, LSHTM** and The MRC/DfID Microbicides Development Programme

Background: Since the MDP started in October 2001, Feasibility Studies have been initiated in six sites: Durban, Johannesburg and Mtubatuba (South Africa), Masaka (Uganda), Mazabuka (Zambia) and Mwanza (Tanzania) in preparation for a RCT of two microbicides. In parallel, working groups (Clinical Trial, Laboratory, Social Science and Community) were established to review and address issues relevant to the development of the protocol and implementation of the trial.

Objectives: The objectives of the Feasibility Studies include: to collect data on HIV incidence and prevalence, sexual behaviour including anal sex and condom use and determine ability to recruit and retain women in follow-up. The objectives of the Clinical Trial Working Group are to address issues relevant to the trial design.

Methods: Six cohorts have been established and details are presented elsewhere. A timetable of topics to be addressed by the Clinical Trials Working Group was drawn up. The group included at least one member from each site, and a central group including the facilitators of the other working groups. An overview of each topic was circulated to all members by email with clear timelines for response, which were summarised prior to review by conference call in order to reach consensus.

Results: Although there is international debate about the control group(s) for microbicide RCTs, investigators were unanimously in favour of a single control group (placebo gel) due to concerns with regard to differential behaviour between women allocated to ‘gel’ or ‘no gel’ and consequent difficulty in interpreting the trial result. The advantages and disadvantages of various lengths of follow-up (6, 9, 12 and 24 months) were considered and will be presented. HIV testing, support and care are not readily available in the participating communities, and as a result HIV-positive women are not excluded from the research in all sites. Nonetheless, it was agreed that only HIV negative women would be eligible for the trial. Limiting the upper age limit in order to select women at highest risk was also discussed, but in the interests of generalisability of the trial result it was decided not to have an upper age restriction. For similar reasons, and because of the difficulty in collecting robust data on the subject, it was decided not to exclude women who reported practising anal sex or use of vaginal products to enhance sex at screening.

Conclusion: Effective communication between the members of this large group was achieved using the strategy described. All the sites and investigators have contributed actively towards the development of the randomised placebo-controlled trial protocol to be implemented in 2004.

Dr. Sheena McCormack
MRC Clinical Trials Unit, 222 Euston Road, London, UK, NW1 2DA
44 20 7670 4708 (Fax) 44 20 7670 4815 (E-mail) smc@ctu.mrc.ac.uk