Approach to HIV Treatment and Care in Future IPM Microbicide Trials Pam Norick, Chief of External Relations 19 June 200

1. Approach to HIV Treatment and Care in Future IPM Microbicide Trials Pam Norick, Chief of External Relations 19 June 2008

2. IPM Mission • Established in 2002 as a non-profitproduct development partnership • Offices in the US, Belgium and South Africa • Mission to prevent HIV transmission by accelerating the development and availability of safe and effective microbicides for use by women in developing countries

3. IPM Donors • Sweden • United Kingdom • United States • European Commission • World Bank • UNFPA • Rockefeller Foundation • Gates Foundation • Belgium • Canada • Denmark • France • Germany • Ireland • Netherlands • Norway

4. Partnerships with Industry

5. IPM Clinical Studies of Dapivirine PK PK/Feasibility Safety/ Feasibility Safety 2008 2009 2007-08 2004-05 2005-06 Safety Safety Safety Male tolerance PK Phase III efficacy Seroconverter protocol Studies in Africa, Europe, United States

6. IPM work in Africa Completed or ongoing studies and activities Possible activity

7. Ethical Guidelines for Clinical Trials • Community engagement • Monitoring of social harms • Informed consent process • Risk reduction counseling • Male/female condoms • Family planning • Management of pregnancy • STI screening and treatment • Testing positive at screening • Counseling and Rx referrals • Participants who seroconvert • Counseling and Rx referrals • Follow-up study protocol • Partnerships/dedicated financing • Treatment for physical harms • Services for study staff • Post-trial access to products

8. Ethical Guidelines Updates • First developed in 2005-06 • Review by ethicists, stakeholders • Revisions in 2007-08 • Consistent with latest UNAIDS, WHO and country guidelines • Document refers principally to clinical trials in developing world • Currently under external review • Expected publication July 2008

9. Seroconversions – IPM Trials • None to date • So far conducted Phase I/II safety trials • Small sample size (N=130 in Africa) • Short enrollment duration (max 6 weeks) • Many trials in Belgium (low HIV incidence) • Preparing for larger safety trials in Africa • IPM 014 A & B (dapivirine gel, N=640, 6 weeks) • IPM 015 (dapivirine ring, N=280, 12 weeks)

10. IPM Plans and Approach Participants who seroconvert during trials offered appropriate HIV-related care and ARV therapy • Plan to implement in multiple ways: • Follow-up study (seroconverter protocol – IPM 007) • Guided referrals for HIV care, treatment, support • Pre-established partnerships with national/local institutions • Dedicated financing if national programs cannot sustain • Pursuing additional support from global donors

11. Approaches to Funding and Delivery • IPM research centres established in areas where capacity for HIV care & treatment exists • Part of site selection and development process • To assure sustainability, develop partnerships with national ministries of health, hospitals, universities, etc. • Dedicated IPM financing in the event national programs cannot assume ongoing responsibility • Funds independent of IPM business/financial status • Insurance company or other mechanisms

12. Key Challenges • Timeframe: participants may not need treatment until years after a trial • Migration: how to ensure access for people who move out of the area or country • Follow-up: how best to keep in touch with participants & inform them of choices • Referral networks: how to ensure their strength over time • Sustainability: what is the best approach? (IPM options paper 2007)

13. Pursuing Additional Support • PEPFAR • Global Fund • Clinton Foundation • Other microbicide donors • Host country governments • UNAIDS/WHO recommend that countries include HIV prevention trial participants in their priority list for access to ARV treatment Ethical Considerations in Biomedical HIV Prevention Trials, 2007