1. www.global-campaign.org UK Campaign for Microbicides www.nfi.net Rectal microbicides Need, development and advocacy Kim Mulji Executive Director Naz Foundation International

2. www.global-campaign.org UK Campaign for Microbicides www.nfi.net Recap on why we need rectal microbicides Brief overview on current research Barriers to their development, regulation and introduction Past, current and planned rectal microbicide advocacy Ongoing and future advocacy issues Structure of presentation

3. www.global-campaign.org UK Campaign for Microbicides www.nfi.net The need for rectal microbicides PopulationNPrevalence of AI Reference MSM in EXPLORE study 429548 – 54%Koblin et al. 2003 High risk women 126832%Gross M et al. 2000 College students 21020%Civic D 2000 Californian residents 35456-8%Erickson PI et al. 1995

4. www.global-campaign.org UK Campaign for Microbicides www.nfi.net Summary of current research Preclinical development of potential candidates (including reverse transcriptase inhibitors) - proof on concept in macaques with Cyanovirin-N in 2003 Mucosal safety and effects on rectal flora Rectal health and baseline studies on the impact of rectal intercourse Sexual behaviour research Distribution studies Dosing and acceptability Expect first human safety trial on RT candidate (UC-781) to start after 1st quarter 2007 “Male tolerance” studies (impact of candidate microbicides on the penis and urethra) Rectal safety studies

5. www.global-campaign.org UK Campaign for Microbicides www.nfi.net Barriers to development, regulation and introduction Different scientific issues than for vaginal microbicides - lack of data on transmission, sexual and other behaviours etc. Lack of funding and interest for research - need more products in pipeline, and more information on anal sex, behaviour, disease etc. Lack of policy support for rectal microbicide research and development Need to define regulatory environment Need to influence rectal microbicide research, development, and introduction Need to address community preparedness

6. www.global-campaign.org UK Campaign for Microbicides www.nfi.net Past, current and planned advocacy Global Campaign for Microbicides work, and www.LifeLube.org North American/global rectal microbicides working group - research report, strategies for working with governments and others, ongoing networking, advocating for more resources for rectal microbicide development, advocacy resource development, activity at conferences and meetings, work on lubricant safety etc. UK/European rectal microbicides working group, aims to highlight the need for rectal microbicides, promote funding for appropriate rectal microbicide research and keeping its members informed of developments. Wants to use global rectal microbicide research report to influence policy in UK and rest of Europe. Wants to address lubricant safety issues, and involve more stakeholders in advocacy work. Currently working closely with global rectal microbicides global working group and developing its own strategy.

7. www.global-campaign.org UK Campaign for Microbicides www.nfi.net Ongoing and future advocacy issues Need to continue to promote for the need for rectal microbicides with policy makers, organisations, communities and individuals Need to continue and increase advocacy for more research and development of rectal microbicides, appropriate testing protocols, regulation, and introduction Promote community preparedness and consultation Need to involve more stakeholders in advocacy work to build a communities of interest, and influence Need to develop networks and strategic alliances Need to advocate for the testing of all vaginal microbicides for rectal safety at the safety trial stage Deal with the introduction of vaginal microbicides and their use rectally Address lubricant safety

8. www.global-campaign.org UK Campaign for Microbicides www.nfi.net Global Campaign for Microbicides Rectal microbicides working groups members UK Campaign for Microbicides Interact Worldwide for hosting the UK Campaign for Microbicides Jim Pickett, Director of Public Policy, AIDS Foundation of Chicago Caroline Haworth, Director of International Programmes, Interact Worldwide Gus Cairns, Trustee, UK Coalition of People Living with HIV and AIDS Thanks to: