1. JOSEPH O’REILLY Deputy Chief Executive REBEKAH WEBB Policy Officer IN COLLABORATION WITH THE GLOBAL CAMPAIGN FOR MICROBICIDES IS THERE AN INVISIBLE CONDOM IN YOUR FUTURE?

2. 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

3. 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

4. New Prevention Technologies: HIV vaccines: Partnership with IAVI since 1996 Microbicides: Partnership with GCM Leading UK Campaign for Microbicides

6. "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

7. What are microbicides? Kill microbes Anything that you can use vaginally or rectally to reduce risk of infection with HIV or other STIs

8. What isn’t a microbicide? Spermicides, such as Nonoxynol-9 Lubes Lemon juice

9. Nonoxynol-9 QUIZ

10. 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

11. 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.”

12. N-9 Contraceptives DELFEN FOAM DURAGEL

13. N-9 Lubricants ELBOW GREASE FORPLAY PLUS WET CLASSIC

14. N-9 Condoms BOOTS CONDOMS DUREX EXTRASAFE MATES NATURAL

15. 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

16. EXERCISE: DESIGN YOUR OWN MICROBICIDE

17. 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

18. Barriers to rectal microbicides: Biology Finance - lack of funding for microbicide development overall Prejudice

19. 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

20. 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 £££

21. 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)

22. What’s in the pipeline? Carraguard TM Buffergel TM - no funding for rectal studies Invisible Condom - prioritising vaginal studies Emmelle TM (Dextrin Sulphate)

23. What would a good rectal microbicide research effort look like? Parallel studies of vaginal and rectal microbicides Address Baltimore research agenda

24. Baltimore Workshop, June 2001 Dosing Methods of Application Dilution Assays (Testing) Rectal shedding

25. 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)

26. SCENARIO: CHAPS 2008 What would your response be?

27. 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

28. 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

29. 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

30. REBEKAH WEBB Tel: 020 7814 6731 rebekah.webb@nat.org.uk