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www.global-campaign.org
UK Campaign for Microbicides
www.nfi.net
Rectal microbicidesNeed, development and advocacy
Kim MuljiExecutive DirectorNaz Foundation International
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
www.global-campaign.org
UK Campaign for Microbicides
www.nfi.net
The need for rectal microbicidesPopulation
N Prevalence of AI
Reference
MSM in EXPLORE study
4295 48 – 54% Koblin et al. 2003
High risk women
1268 32% Gross M et al. 2000
College students
210 20% Civic D 2000
Californian residents
3545 6-8% Erickson PI et al. 1995
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
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
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.
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
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:
