art program of the hiv vaccine trials network margaret wecker, phd associate director, scientific...

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

• 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

HVTN Clinical Research Sites

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

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

• 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

• 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

• 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

• 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

• 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

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

Future Challenges

• Implementation

• Sustainability

• Shifting need pattern from developing world to developed world?