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

02463 SAFETY OF CARRAGUARD® AMONG HIV-POSITIVE WOMEN AND MEN IN SOUTH AFRICA

Morar, Neetha S*
Braunstein S**, Jones H**, Moodley M*, Aboobaker J*, Ndaba M*, Ndlovu G***, van de Wijgert J****, Ramjee G*.
*Medical Research Council, South Africa; **Population Council, New York, USA; ***Population Council, Johannesburg, South Africa; ****International Antiviral Therapy Evaluation Center, Netherlands.

Background: Ideally, microbicides will be available over-the-counter. It is likely that microbicides will be used by women and men who are not aware of their HIV status. HIV-infected persons may also use a microbicide to avoid sexually transmitted infections, or to protect their partners. It is important to know whether HIV-positive women and men can safely use a potential microbicide.

Methods: We conducted a Phase I study to assess the safety and acceptability of Carraguard“, the Population Council’s lead candidate microbicide, among HIV-positive women and men in Durban, South Africa. Twenty healthy HIV-positive sexually abstinent women and men, and 20 HIV-positive sexually active women were recruited from health service and community centers in Durban, South Africa. Eligibility criteria included CD4 count >200, menstrual regularity, and absence of STIs or symptomatic vaginal infection. Consenting participants were randomized to use Carraguard, placebo (methyl-cellulose), or condoms only. Women inserted one dose of gel vaginally every evening for 14 intra-menstrual days, and men applied one dose of gel directly to the penis every evening for 7 days. Participants underwent clinical exam (including colposcopy for women) and laboratory testing for infections per protocol at follow-up visits.

Results: Preliminary, blinded findings for sexually abstinent women and men only are included; results for sexually active women will be included in the final presentation. Sixty percent of women reported current contraceptive use, with hormonal injectables and male condoms being the two most common methods. At baseline, 70% of women and 60% of men reported condom use in the last month. Eighty-five percent of women and 80% of men had previously been HIV tested; one woman and two men reported an STI in the prior 3 months; and few participants reported an AIDS-related illness in the previous 5 years. At baseline, 46% of women and 36 % of men were taking medication for HIV (none were using anti-retroviral therapy); during the study, 24% of women and 8% of men took medication(s) for HIV. No serious adverse events occurred during the study. A total of 117 adverse events (AEs) occurred, 103 in women and 14 in men. Among women, AEs were generally equally distributed across study arms, and the majority (79%) were mild. Sixty percent were related to the reproductive system (e.g. vaginal discharge, itching, burning); none of these were severe, and two (both mild) were considered probably related to product use. Nine women ever reported a genital symptom. Of the 5 genital exam findings for women during follow-up, 3 had superficial epithelial disruption and none had deep disruption. Among men, the majority of AEs were unrelated to the reproductive system (79%), mild (86%), occurred in the condoms-only arm (79%), and none were considered probably related to product use. Three men ever reported a genital symptom, and there were no positive tests for inflammation or genital findings with epithelial disruption in men.

Conclusion: Preliminary blinded results show that the product and the placebo appear to be safe in HIV-positive sexually abstinent men and women.

Neetha S Morar
Medical Research Council, HIV Prevention and Vaccine Research, PO Box 70380, Overport, 4067 South Africa
(Telephone) +27-31-203-4700 (Fax) +27-31-203-4702 (E-mail) Neetha.Morar@mrc.ac.za