1. HPTN Future Directions January 22, 2003 Bethesda, MD

2. What’s Next • Building on accomplishments • Short term goals • Science completion/implementation • Long term goals • Science generation

3. What Has Worked • Science generation • Including input from a variety of sources, concepts, review, quality of protocols, multidisciplinary inputs • Focus on international infrastructure • Cooperative agreements as a funding mechanism • Multisdisciplinary integration • Governance

4. Short Term Goals • Goal 1: Complete Science in Progress • Goal 2: Capacity Building • Goal 3: Science Generation • Goal 4: Science Implementation

5. Goal 1: Completing Science in Progress • 012: Perinatal: Nevirapine • 015: Behavioral: EXPLORE • 016A: Microbicides/Behavioral: Couples Counseling • 024: Perinatal: Chorioamnionitis • 037: Substance use: Peer networks • 032/049/050: Microbicides Phase I

6. Goal 2: Capacity Building • Working in places where incidence is high • We need to stay there and ensure that we can do the important trials • Laboratory • GCP • GLP • Ethics • Community  • continuous improvement process • network is ready for prevention clinical trials

7. Goal 2: Capacity Building • Preparedness studies • Cohort identification and follow-up • 033: China, India, Russia • 034: India • 036: Peru • 055: South Africa, Tanzania, Zambia • 016a: Zimbabwe, Malawi (Lilongwe and Blantyre)

8. Goal 3: Science Generation • Working Groups • Met • Assessed • Identified gaps • Matched gaps to HPTN strengths and mission • Stimulated and competed concepts • Brought concepts to protocol stage • Spun off others into the R01 pool

9. Goal 4: Science Implementation • 035: Microbicides: BufferGel and Pro2000 • 039: STDs (R01): Herpes • 040: Perinatal: Postnatal ART • 043: Behavioral (R01): Community VCT • 046: Perinatal: Nevirapine during Breastfeeding • 052: Antiretrovirals: Reducing Transmission • 054: Perinatal: Access to NVP with and without HIV VCT • 056: Rectal Microbicides

10. Long-Term: Science Generation • Unmet needs • Multidisciplinary • Array of epidemiological environments • Implemented and completed with quality • Landmark trials: Phase III HIV incidence endpoint

11. If Not in This Network, Then Where Will Phase III Prevention Trials Occur? • The field needs Phase III prevention trials • Industry not interested • Need to be multidisciplinary • Beyond any one academic institution • Beyond any one NIH institute • Beyond any one network

12. What Would We Change? • New ‘rapid discovery’ regulatory model to facilitate protocols with FDA • Resources commensurate with the scope of responsibilities as Phase III non-vaccine network • Product procurement contract to obtain study products more quickly

13. In Conclusion • This is an excellent use of funds • Important to preserve the triple track • Treatment/ Vaccines/ Prevention • Focus on prevention is of vital significance • The network is the right approach • This network represents the best in the field • HPTN has been productive, despite significant barriers and challenges

14. Are we in the ballpark? • High quality trials • Definitive • Meeting FDA standards • With HIV seroincidence endpoints • Resources need to match expectations and breadth of the agenda

15. Comparable Efforts? • HSV Vaccine (GSK) : $200m • HIV Vaccines (VaxGen): $200m • ID Prevention Trial: $45m • HIV Interleukin-2 (Chiron): $160m • 035: $60-100m (est) • 052: $100m (est)