HPTN Future Directions January 22, 2003 Bethesda, MD

What’s Next  Building on accomplishments  Short term goals Science completion/implementationScience completion/implementation  Long term goals Science generationScience generation

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

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

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

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  Community continuous improvement processcontinuous improvement process network is ready for prevention clinical trialsnetwork is ready for prevention clinical trials

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)

Goal 3: Science Generation Working Groups  Working Groups MetMet AssessedAssessed Identified gapsIdentified gaps Matched gaps to HPTN strengths and missionMatched gaps to HPTN strengths and mission Stimulated and competed conceptsStimulated and competed concepts Brought concepts to protocol stageBrought concepts to protocol stage Spun off others into the R01 poolSpun off others into the R01 pool

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

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

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

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

In Conclusion  This is an excellent use of funds  Important to preserve the triple track Treatment/ Vaccines/ Prevention 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

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

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)