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

02420_2 OPTIMAL ANALYSIS OF MRI DATA TO QUANTITATE THE DISTRIBUTION OF A VAGINAL PRODUCT

Barnhart, Kurt*
Shera, David^; Pretorius, Es”; Shabbaut, M^
*Dept Ob/Gyn, Center for Clinical Epidemiology & Biostatistics, University of Pennsylvania; ^Children’s Hospital of Philadelphia; “Dept. Radiology, University of Pennsylvania

Introduction: MRI can be used to safely and acutely visualize and quantitate spread of a potential microbicide formulation. We have used MRI to characterize the spread of a number of vehicles and active compounds including Gynol II, 1.0% C31Gg, 6% Cellulose Sulfate, Replens and KY jelly; at a variety ofvolumes. By combining the experience of these trials we have been able to analyze MRI as a technique to compare gels and optimize experimental conditions. This abstract summarizes some of these conclusions.

Methods: Raw data from 5 experimental protocols and greater than 30 women were combined. When possible, data were aggregated. We explored a variety of analytic techniques, statistical methods and experimental designs to determine the optimal use of MRI to quantiate intra-vaginal spread of a potential microbicide.

Results: MRI has outstanding intra-person validity and reproducibility. Using this data the best characterization of intra-vaginal spread of a vaginal gel is a linear relationship with time (linear mixed model). The slope of the curve is dependant on the specific gel, the volume, time and the baseline vaginal dimensions. The baseline vaginal dimensions of length below the cervix and transverse measurement at the flexion may be dependant on weight and gravity respectively. Spread is best characterized in two distinct anatomical categories: the upper and lower vagina, using the pelvic diaphragm to delineate the two. Individual gels do not spread equally in both the upper and lower vagina.

Conclusions: MRI can be reproducibly used to assess and compare intra-vaginal spread of a microbicide. Given the complex anatomic shape of the human vagina a simple linear measurement in one plane is inadequate to characterize spread. A summary measurement of multiple assessments of both the upper and lower vagina best characterizes vagina coverage. Paired study designs provide the most efficient comparison of two products or volumes. This research was funded by CONRAD

Dr. Kurt T. Barnhart
University of Pennsylvania Medical Center, Dept. Ob/Gyn, 3701 Market Street, Suite 800, Philadelphia, PA 19104-5509
(Telephone) 215-662-2974 (Fax) 215-615-4200 (E-mail) kbarnhart@mail.obgyn.upenn.edu