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

02104 A PHASE-TWO SAFETY STUDY OF PRO 2000/5 GEL IN SEXUALLY ACTIVE FEMALES IN UGANDA

Byomire, Helen
Bukenya,M Lacey,C Byaruhanga,R Okong,P Nunn,A Mccormack,S Kamali,A Grosskurth,H

Background:A phase-two study to assess the safety of PRO 2000/5 gel is being carried out in Kampala, Uganda. The objective of the study is to assess systemic and local safety of PRO 2000/5 gel inserted vaginally, as part of research conducted to identify a safe and effective vaginal microbicide to prevent HIV acquisition.

Methodology:The study is a randomised placebo controlled trial being conducted in a cohort of 100 sexually active females of reproductive age in a busy hospital in Kampala. Participants are screened for sexually transmitted infections and HIV and are randomised to either PRO 2000/5 gel or its matched vehicle placebo twice daily for 4 weeks, or to an observation-only arm. Participants are reviewed fortnightly. Evidence of systemic adverse events is sought using various laboratory procedures, which include haematology and biochemistry done at screening and at 4 weeks after randomisation. Local adverse events are assessed every two weeks using a structured questionnaire, clinical examination, colposcopy, and Nugent score on Gram stained specimens based on vaginal swabs.

Results:A total of 65 women have been screened so far, 35 of whom have been randomised into the trial (5 in the observation-only arm and 30 in the gel arms). To-date, 20 participants have completed the study, 16 in the gel arms and 4 in the observation-only arm. None of the women randomised to gel use has indicated any difficulty in inserting the gel and no withdrawal of consent has been observed. One participant in the gel arm was lost to follow up.Two out of the sixteen participants in the gel arm reported mild vaginal itching and three reported thirst in the first week of gel use. Two participants were found to have superficial epithelial disruptions. There were no other cervico–vaginal epithelial disruptions, no significant changes in vaginal flora and no evidence of systemic toxicity related to gel use observed.
Conclusion:We have observed a good acceptability of gel use and preliminary results based on the first 20 participants seem to suggest a satisfactory safety profile of PRO 2000/5 gel.

Mrs Helen Byomire-Ndagije
P.O.Box 49 Entebbe Uganda, East Africa
(Telephone) 256 41 320272/320042 or 256 77 469094 (Fax) 256 321137 (E-mail) helenbyomire@yahoo.co.uk