HPTN Future DirectionsHPTN Future Directions

January 22, 2003January 22, 2003

Bethesda, MDBethesda, MD

What’s NextWhat’s Next

Building on accomplishmentsBuilding on accomplishments

Short term goalsShort term goals• Science completion/implementationScience completion/implementation

Long term goalsLong term goals• Science generationScience generation

What Has WorkedWhat Has Worked

Science generationScience generation Including input from a variety of sources, concepts, Including input from a variety of sources, concepts,

review, quality of protocols, multidisciplinary inputsreview, quality of protocols, multidisciplinary inputs

Focus on international infrastructureFocus on international infrastructure Cooperative agreements as a funding Cooperative agreements as a funding

mechanismmechanism Multisdisciplinary integrationMultisdisciplinary integration GovernanceGovernance

Short Term GoalsShort Term Goals

Goal 1: Complete Science in Goal 1: Complete Science in Progress Progress

Goal 2: Capacity BuildingGoal 2: Capacity Building

Goal 3: Science GenerationGoal 3: Science Generation

Goal 4: Science ImplementationGoal 4: Science Implementation

Goal 1: Completing Science in Goal 1: Completing Science in ProgressProgress

012: Perinatal: Nevirapine012: Perinatal: Nevirapine

015: Behavioral: EXPLORE015: Behavioral: EXPLORE

016A: Microbicides/Behavioral: 016A: Microbicides/Behavioral: Couples CounselingCouples Counseling

024: Perinatal: Chorioamnionitis024: Perinatal: Chorioamnionitis

037: Substance use: Peer networks037: Substance use: Peer networks

032/049/050: Microbicides Phase I032/049/050: Microbicides Phase I

Goal 2: Capacity BuildingGoal 2: Capacity Building Working in places where incidence is highWorking in places where incidence is high We need to stay there and ensure that we can We need to stay there and ensure that we can

do the important trialsdo the important trials LaboratoryLaboratory GCPGCP GLPGLP EthicsEthics Community Community 

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

Goal 2: Capacity BuildingGoal 2: Capacity Building

Preparedness studiesPreparedness studies Cohort identification and follow-upCohort identification and follow-up 033: China, India, Russia033: China, India, Russia 034: India034: India 036: Peru036: Peru 055: South Africa, Tanzania, Zambia055: South Africa, Tanzania, Zambia 016a: Zimbabwe, Malawi (Lilongwe and 016a: Zimbabwe, Malawi (Lilongwe and

Blantyre)Blantyre)

Goal 3: Science GenerationGoal 3: Science Generation

 Working GroupsWorking Groups• MetMet• AssessedAssessed• Identified gapsIdentified gaps• Matched gaps to HPTN strengths and Matched gaps to HPTN strengths and

missionmission• 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 ImplementationGoal 4: Science Implementation

035: Microbicides: BufferGel and Pro2000035: Microbicides: BufferGel and Pro2000 039: STDs (R01): Herpes039: STDs (R01): Herpes 040: Perinatal: Postnatal ART040: Perinatal: Postnatal ART 043: Behavioral (R01): Community VCT043: Behavioral (R01): Community VCT 046: Perinatal: Nevirapine during 046: Perinatal: Nevirapine during

BreastfeedingBreastfeeding 052: Antiretrovirals: Reducing 052: Antiretrovirals: Reducing

TransmissionTransmission 054: Perinatal: Access to NVP with and 054: Perinatal: Access to NVP with and

without HIV VCTwithout HIV VCT 056: Rectal Microbicides056: Rectal Microbicides

Long-Term: Science Long-Term: Science GenerationGeneration

Unmet needsUnmet needs MultidisciplinaryMultidisciplinary Array of epidemiological Array of epidemiological

environmentsenvironments Implemented and completed with Implemented and completed with

qualityquality Landmark trials: Phase III HIV Landmark trials: Phase III HIV

incidence endpointincidence endpoint

If Not in This Network, Then Where Will If Not in This Network, Then Where Will Phase III Prevention Trials Occur?Phase III Prevention Trials Occur?

The field needs Phase III prevention trialsThe field needs Phase III prevention trials

Industry not interestedIndustry not interested

Need to be multidisciplinaryNeed to be multidisciplinary

Beyond any one academic institutionBeyond any one academic institution

Beyond any one NIH instituteBeyond any one NIH institute

Beyond any one networkBeyond any one network

What Would We Change?What Would We Change?

New ‘rapid discovery’ regulatory model to New ‘rapid discovery’ regulatory model to facilitate protocols with FDAfacilitate protocols with FDA

Resources commensurate with the scope of Resources commensurate with the scope of responsibilities as Phase III non-vaccine networkresponsibilities as Phase III non-vaccine network

Product procurement contract to obtain study Product procurement contract to obtain study products more quicklyproducts more quickly

In ConclusionIn Conclusion

This is an excellent use of fundsThis is an excellent use of funds Important to preserve the triple trackImportant to preserve the triple track

• Treatment/ Vaccines/ PreventionTreatment/ Vaccines/ Prevention Focus on prevention is of vital significanceFocus on prevention is of vital significance The network is the right approachThe network is the right approach This network represents the best in the fieldThis network represents the best in the field HPTN has been productive, despite HPTN has been productive, despite

significant barriers and challengessignificant barriers and challenges

Are we in the ballpark?Are we in the ballpark?

High quality trialsHigh quality trials DefinitiveDefinitive Meeting FDA standardsMeeting FDA standards With HIV seroincidence endpointsWith HIV seroincidence endpoints Resources need to match expectations Resources need to match expectations

and breadth of the agendaand breadth of the agenda

Comparable Efforts?Comparable Efforts?

HSV Vaccine (GSK) : $200mHSV Vaccine (GSK) : $200m HIV Vaccines (VaxGen): $200mHIV Vaccines (VaxGen): $200m ID Prevention Trial: $45mID Prevention Trial: $45m HIV Interleukin-2 (Chiron): $160mHIV Interleukin-2 (Chiron): $160m

035: $60-100m (est)035: $60-100m (est) 052: $100m (est)052: $100m (est)