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ART Program of the HIV Vaccine Trials Network Margaret Wecker, PhD Associate Director, Scientific Operations and Business Development HVTN Organization HVTN functions under a cooperative agreement with the US National Institutes of Health

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art program of the hiv vaccine trials network

ART Program of the HIV Vaccine Trials Network

Margaret Wecker, PhD

Associate Director, Scientific Operations and Business Development

hvtn organization
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
provision of treatment in hiv 1 vaccine trials in developing countries the lancet september 2003
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.

challenges to fulfilling our promise
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
funding and prioritization
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”
limitations of the program
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.
hvtn art program
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
processes
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
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

Responsibilities
to date 2 of participants have become hiv infected
To Date < 2% of Participants Have Become HIV-Infected

As of September, 2007: 79 HIV-infected participants, out of a total of 5764 enrollees.

future challenges
Future Challenges
  • Implementation
  • Sustainability
  • Shifting need pattern from developing world to developed world?