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

02577_2 CLINICAL TRIAL OF MICROBICIDE SAFETY AND ACCEPTABILITY AMONG HIV-INFECTED WOMEN IN NORTHERN THAILAND

McLean, Catherine*
Kilmarx, PH*, Van De Wijgert, J**, Chaikummao, S***, Sternberg ,M*, Achalapong, J****, Bollen, LJM***, Markowitz, LE*, Tappero, JW*,***
*National Center For HIV, STD, and TB Prevention, Centers For Disease Control and Prevention, USA; **The Population Council, USA; ***Thailand MOPH – U.S. CDC Collaboration; ****Chiang Rai Hospital, Thailand

Background: Vaginal microbicides to prevent HIV transmission may be used by HIV-infected women because they do not know their HIV status or they believe the product will protect sex partners from HIV infection. Few studies evaluating candidate microbicide safety among HIV-infected women have been conducted.

Methods: We designed a study to evaluate safety, acceptability, and vaginal HIV viral shedding with vaginal use of 3% carrageenan gel (Carraguard“) among HIV-infected women in Northern Thailand. Eligibility criteria included a CD4 cell count of 50-500 cells/µL, not currently taking antiretroviral therapy, abstinence or a steady sex partner who was also HIV-infected, and regular menstrual cycles.

Results: The study was a three-arm, crossover design, including carrageenan gel, placebo (methylcellulose) gel, and a “no product” arm. Participants were randomized to one of the six possible study arm sequences. Primary endpoints included cervico-vaginal cell-free viral load, cellular viral replication, infectious virus, and epithelial disruption following seven days of product use. Secondary endpoints included vaginal symptoms, bacterial vaginosis, yeast infection, and other reproductive tract infections. Following a three-week washout period, participants crossed over to the next study arm, with each woman serving as her own control.

Conclusions: A cross-over study design may be an efficient method of evaluating safety of candidate microbicides among HIV-infected women, enhancing comparability of study arms and minimizing sample size requirements.

Dr. Catherine McLean
Centers for Disease Control and Prevention, 1600 Clifton Road, MS E-02, Atlanta, GA 30333, USA
(Telephone) (404) 639-8467 (Fax) (404) 639-8610 (E-mail) CMcLean@cdc.gov