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_1 INTRA-VAGINAL DISTRIBUTION OF CELLULOSE SULFATE

Barnhart, K*
Pretorius, Es^; Nasution, M”; Timbers, K; Linton K’; Mauck, C’
*Dept Ob/Gyn, Center for Clinical Epidemiology & Biostatistics, University of Pennsylvania; ‘CONRAD; ^Dept. Radiology, University of Pennsylvania; “Family Health International

Introduction: A microbicide formulation of 6% sodium cellulose sulfate (CS) has been demonstrated to be safe for human subjects, although the optimal applied volume of gel is not known. Larger volumes (5 ml) of gel lead to increased leakage, and smaller volumes (2.5 ml) of gel may provide insufficient vaginal epithelial coverage. Given concern that a dose volume of 2.5 ml may not provide sufficient vaginal coverage to prevent sexually transmitted diseases, including HIV, this study was performed to evaluate intravaginal gel spread and gel leakage in patients who used 2.5 ml and 3.5 ml dose volumes of CS.

Methods: Blinded crossover study of CS gel delivered in 2.5 ml and 3.5 ml volumes to 6 women, three parous and three nulligravid. Each woman was imaged using three-dimensional MRI with gadolinium chelate contrast added to the gel.. Imaging was performed at baseline, and at 5, 20, 35 and 50 minutes after product insertion. Each woman used both gel volumes twice: once with ambulation following insertion and once without ambulation. The sequence was determined by randomization.

Results: Most linear gel spread took place in the first five minutes after insertion, although some continued spread was seen when ambulation took place. Lateral spreading appeared to continue after linear spreading had slowed or stopped. Ambulation also increases gel spread. At times greater than 5 minutes, ambulation had a greater effect on gel distribution than did gel volume. The degree of spreading achieved at 5 and 20 minutes was approximately 60% of both linear distance and surface contact in any group. By 50 minutes, coverage ranged from 53.1% to 84.5% of the linear distance covered and surface contact ranged from between 61.7% - 85.9%. Using a larger volume of gel increased linear spreading but had less consistent effects on lateral spread as measured by surface contact. Within ambulating groups, use of the larger volume increased linear spreading by 4-23% at each time point and increased surface contact by 5-46% at all time points. The greatest linear spreading (49.2 mm) and surface contact (85.9%) 50 minutes after product insertion were in the group of women who used 3.5 ml of gel and ambulated. There was no clear pattern of effect by parity. Most of the women had bare spots in coverage, particularly in the proximal vagina. Leakage was not a severe problem in any of the groups.

Conclusions: The spreading of CS in the absence of intercourse did not result in complete vaginal coverage, even when observed 50 minutes after product insertion. The use of 3.5 ml compared with 2.5 ml, and the practice of ambulation, generally increased gel spread. Results are generally consistent with other MRI studies of vaginal products. This research was funded by CONRAD.

Dr. Kurt T. Barnhart
University of Pennsylvania, 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