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?