December 6, 2011
A coalition of HIV advocacy groups are calling on all people with HIV to take 10 minutes to complete a survey they hope will help speed the pace of HIV cure research.
At issue are the kinds of risks that the U.S. Food and Drug Administration (FDA) will allow in early phase clinical studies of promising treatments to either eradicate HIV from the body or to help the immune system better control the virus without the need for antiretroviral drugs.
"There are complex considerations in the FDA's regulation of early studies that might carry certain health risks, especially if those studies are designed more to move the science forward than to achieve an immediate cure in the individual," said David Evans, director of research advocacy for Project Inform in San Francisco.
"We believe that soliciting the opinions of people with HIV regarding the potential risks involved will help inform discussions regarding the design of these trials, and shed light on the extent to which individuals are willing to assume some risk even if the study would only help people further down the road," Evans continued.
Evans, in partnership with Nelson Vergel, director of the Program for Wellness in Houston, and Richard Jefferys from the Treatment Action Group in New York City, devised the survey to help measure the willingness of people with HIV to participate in research for more altruistic reasons and to gauge the factors that are most strongly associated with a person's willingness.
The activists are hoping that the results of the survey may lead to more openness toward community input on the part of the branch of the FDA that will be responsible for reviewing many cure-oriented treatments, called the Center for Biologics and Evaluation Research (CBER).
"Several researchers are designing studies right now that will soon ask people to take some risks to learn more about new approaches to cure HIV. It is important for the HIV community to let them and the FDA know what it is willing to do to advance a cure of an illness that kills more than 2 million people per year," said Vergel.
Vergel and his colleagues are hoping that people with HIV and their service providers will spread word widely about the survey. The larger the number of people who take it, and the greater the diversity of the survey-takers, the more legitimacy the survey results will have. The group intends to make the results of the survey public before the launch of the 2012 International AIDS Conference that will take place in July in Washington, D.C.