art program of the hiv vaccine trials network margaret wecker, phd associate director, scientific...
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ART Program of the HIV Vaccine Trials Network
Margaret Wecker, PhD
Associate Director, Scientific Operations and Business Development
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HVTN Organization
• HVTN functions under a cooperative agreement with the US National Institutes of Health
• The Division of AIDS (DAIDS) is within the National Institute for Allergy and Infectious Disease
• HVTN established in 2000 and has been awarded a second 7-year grant cycle, starting in 2007
• Network of research institutions 14 domestic sites, and 14 international sites on 5 continents
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HVTN Clinical Research Sites
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HVTN Sites
Domestic International
Atlanta Rio Chang Mai
Birmingham Sao Paulo Cape Town
Boston Lima Durban
Chicago Iquitos Klerksdorp
Nashville Port-au-Prince Pretoria
New York City San Juan Soweto
Philadelphia DR Lausanne
Rochester Kingston
Seattle
San Francisco
Raleigh
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Provision of Treatment in HIV-1 Vaccine Trials in Developing Countries.
(The Lancet, September, 2003)
The HIV Vaccine Trials Network (HVTN), a collaboration of scientists from 28 research sites (figure), announced this year that participants who become infected during HVTN vaccine trials will receive long-term antiretroviral treatment.
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Challenges to Fulfilling our Promise
• Funding
– NIH grant will not support purchase of ART
– Mandate is to perform HIV vaccine research
– Cannot support monitoring or testing outside a clinical trial
• 7-year grant cycle…. But a lifetime commitment?
• Start of treatment may be years after completion of clinical trial
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Funding and Prioritization
• A separate fund was established – Seattle Vaccine Research Fund
• Vaccine developers asked to donate to this fund to support provision of ART to participants in HVTN HIV vaccine trials
• With limited funds available, prioritization is necessary– Goal is to ensure that volunteers who become HIV infected during
the course of a HVTN HIV vaccine trial have access to ART when they meet local treatment guidelines until a national plan is in place
– Fund of “last resort”
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Limitations of the program
• Limited to HVTN Sites in countries outside the US without government plan for ART
• Unable to provide support for monitoring the participant outside the context of a clinical trial
– HVTN does have several follow-up trials offered to HIV-infected trial participants including one trial in which participants receive ART
• Unable to provide support for partners or immediate family
• Unable to provide support for concurrent STIs, OIs etc.
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HVTN ART Program
• Purchase of ART
• CD4, Viral load and safety monitoring associated with ART
• Individual sites have ownership of ART plans– HVTN Core works with sites to prepare country-specific
ART Plans
– Provide information for treatment cost estimates
– Identify gaps in funding for ppts
– Revised as necessary consistent with status of national plans
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Processes
• PPT becomes HIV infected during HVTN vaccine trial
– Issued ID Card and Brochure
– Is tracked in HVTN database and a serial number is provided for ART fund tracking
• Application for funding
– Serial number or ppt identifier
– Treatment proposal
• Funds transferred to allow provision of ART
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Responsibilities
• SVRF
– Maintain database
– Evaluate requests
– Disburse funds to RPIC
– Receive reports of fund disbursement and program termination
• RPIC (The fiduciary)
– Applies for funding
– Report of fund disbursement
purchase of medication for given participant
– Report termination of program
death
national plan status change
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To Date < 2% of Participants Have Become HIV-Infected
As of September, 2007: 79 HIV-infected participants, out of a total of 5764 enrollees.
Infections from: Number of infections
Phase I-II protocols 22
HVTN 502 47
HVTN 903 (a vaccine preparedness trial, not eligible)
10
non eligible countries (including US) 45
Infections from eligible countries and studies 24
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Future Challenges
• Implementation
• Sustainability
• Shifting need pattern from developing world to developed world?