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Published on August 18, 2011

Regional Center for Infectious Disease Participates in Global Trial on HIV/AIDS

The Regional Center for Infectious Disease at Cone Health is enrolling asymptomatic HIV-infected individuals in a major new international clinical trial. The new trial seeks to determine if starting medications while the HIV infected patient’s immune system is healthy is more effective than waiting until after the virus has weakened the immune system.

“While it is clearly better and safer for HIV infected patients to start antivirals well before their immune systems become compromised, even the experts cannot agree upon exactly what time point infected patients should start,” explains Kees Van Dam, M.D., principal investigator for the study at the Regional Center for Infectious Disease at Cone Health. “We believe the study will definitively answer this question and many others as we enter a new era of HIV care in the 21st century.”

HIV is spread through sexual contact, mucosal exposure to certain body fluids, such as blood, and from mother to child. The virus attacks the immune system, leaving it susceptible to normally harmless infections which can become deadly. As of 2010, more than 36,000 North Carolinians had been diagnosed with HIV. Nearly 12,000 of those patients have died since the disease was first identified in 1983.

The Strategic Timing of Antiretroviral Treatment (START) clinical trial, is one of the largest and one of only a few trials seeking data globally to prove that HIV-infected individuals taking antiretrovirals sooner rather than later may have less risk of developing AIDS or other serious illnesses.

The START trial is being offered only at top-performing research institutions and is co-funded by the National Institute of Allergy and Infectious Diseases, part of the National Institute of Health.
It is being conducted in 30 countries and will enroll 4,000 HIV-infected men and women 18 years of age and older who are not showing symptoms and have never taken antiretroviral therapy. Once enrolled, they will be seen by study staff at regular intervals for up to five years.

Study clinicians will select the appropriate antiretroviral regimen for each participant from a pre-approved list based on U.S. Department of Health and Human Service treatment guidelines.

“While the focus of the study is to evaluate the potential benefits of early intervention, outcomes of the study may also serve to encourage more primary care physicians to test for HIV and for the public to seek testing,” says Timothy Lane, MD, Site Investigator for the AIDS Clinical Trials Group at the Regional Center for Infectious Disease.

The Regional Center for Infectious Disease is one of the first of its kind in North Carolina and represents a collaborative effort between Cone Health and community partners, including Triad Health Project, Cone Health Foundation, Central Carolina Health Network and Family Service of the Piedmont.

Individuals interested in participating in the study should contact: Kim Epperson at 336-832-3262 or email her at

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