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IS THERE AN INVISIBLE CONDOM IN YOUR FUTURE?. JOSEPH O’REILLY Deputy Chief Executive REBEKAH WEBB Policy Officer IN COLLABORATION WITH THE GLOBAL CAMPAIGN FOR MICROBICIDES. NAT. UK-based HIV/AIDS policy development and advocacy organisation
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IS THERE AN INVISIBLE CONDOM IN YOUR FUTURE? JOSEPH O’REILLY Deputy Chief Executive REBEKAH WEBB Policy Officer IN COLLABORATION WITH THE GLOBAL CAMPAIGN FOR MICROBICIDES
NAT • UK-based HIV/AIDS policy development and advocacy organisation • Working on UK and international AIDS policy issues organised around four pillars: • HIV stigma and discrimination • Treatment access • Leadership • Prevention
Prevention: • Reduction of new HIV infections amongst communities most at risk of HIV in the UK and globally by: • Supporting new prevention technologies • Supporting best practice in sexual health promotion • Promoting harm reduction policy and best practice
New Prevention Technologies: • HIV vaccines: • Partnership with IAVI since 1996 • Microbicides: • Partnership with GCM • Leading UK Campaign for Microbicides
"We are not looking for a magic bullet, we are looking for a constellation of effective prevention products. An effective microbicide is a missing star. A successful vaccine is a missing star. We need both."- Peter Piot, Executive Director of UNAIDS
What are microbicides? • Kill microbes • Anything that you can use vaginally or rectally to reduce risk of infection with HIV or other STIs
What isn’t a microbicide? • Spermicides, such as Nonoxynol-9 • Lubes • Lemon juice
What is the new guidance? • N-9 containing products should not be used rectally • N-9 condoms should not be promoted for safe sex • There is no evidence they protect better than condoms lubricated with other products
What about the UK? • Has revised its ‘summary of product characteristics’ for N-9: “This product does not protect against HIV (AIDS) or other STIs. A latex condom should be used to protect against the spread of STIs.”
N-9 Contraceptives DELFEN FOAM DURAGEL
N-9 Lubricants ELBOW GREASE FORPLAY PLUS WET CLASSIC
N-9 Condoms BOOTS CONDOMS DUREX EXTRASAFE MATES NATURAL
Why should gay men be interested? • San Francisco study: • Gay men believe that N-9 offers protection • They are seeking out N-9 to reduce risk • Even after CDC warnings and outreach • 41% of MSM who had used N-9 in the past year had done so without a condom because they thought N-9 was protective
What do we want in a microbicide? • Hassle-free: inexpensive; easily accessible; easy to use • Safety: tested; no allergies; no inflammation; safe for frequent use • Effectiveness: 100%? • Acceptability: partners; condoms; lubes
Barriers to rectal microbicides: • Biology • Finance - lack of funding for microbicide development overall • Prejudice
Biology of the rectum: • Open-ended unlike the vagina • The lining is thinner than the vagina • More CD4 receptor cells (vulnerable to HIV infection) • Alkaline, not acidic like the vagina
What does it cost? • £500 million needed over next five years • Worldwide spending will be £150 million • A shortfall of at least £300 million • Discovery to Phase II costs £13 million • Phase III trial costs £30 million £££
What’s in the pipeline? • 60 product leads • 34 in pre-clinical studies • 15 in Phase 1 • 4 in Phase 2 • 3 in Phase 2/3 • 1 going into Phase III (Carraguard)
What’s in the pipeline? • Carraguard TM • Buffergel TM - no funding for rectal studies • Invisible Condom - prioritising vaginal studies • Emmelle TM (Dextrin Sulphate)
What would a good rectal microbicide research effort look like? • Parallel studies of vaginal and rectal microbicides • Address Baltimore research agenda
Baltimore Workshop, June 2001 • Dosing • Methods of Application • Dilution • Assays (Testing) • Rectal shedding
What research is happening? • Two base-line studies of inflammation and injury during anal sex • Male tolerance studies • Some phase 1 studies (HIV +ve and -ve)
Goals • Raise awareness and mobilise political support for increased funding for microbicide R&D • Create a supportive policy environment for timely development and introduction of new prevention technologies which ensures their global accessibility and use • Ensure that as science proceeds, the public interest is protected and the rights and interests of trial participants, users and communities are fully represented and respected
What can you do? • Talk to your colleagues about microbicides • Think about how microbicides would impact on your work • Organise a presentation on microbicides at your workplace • Contact the UK Campaign for Microbicides at NAT
Where to get more info… • www.LifeLube.org - for information on gay men and microbicides • www.global-campaign.org - sign up for email updates • www.nat.org.uk - look out for new report
REBEKAH WEBB Tel: 020 7814 6731rebekah.webb@nat.org.uk