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UNC researchers launch international clinical trial to study neurological disease in HIV-AIDs patients
CHAPEL HILL -- Researchers at the University of North Carolina at Chapel Hill are preparing to launch an international clinical trial studying neurological disease in people with HIV and AIDS that is believed to be one of the largest neurological studies ever undertaken in the developing world.
June 10, 2004
UNC researchers launch international clinical trial to study neurological disease in HIV-AIDs patients
BY TOM HUGHES
UNC School of Medicine
CHAPEL HILL -- Researchers at the University of North Carolina at Chapel Hill are preparing to launch an international clinical trial studying neurological disease in people with HIV and AIDS that is believed to be one of the largest neurological studies ever undertaken in the developing world.
The study, called the International Neurological Study, seeks to determine how prevalent neurological diseases such as AIDS dementia complex and peripheral neuropathy are among HIV-AIDS patients in resource-limited countries and what the most effective treatments are.
Nearly 1,000 patients will be enrolled at 12 international sites. Funding for the study comes from a five-year, $3.75-million grant from the National Institute of Mental Health, a component of the National Institutes of Health. As part of the study, the NIMH is sponsoring a conference today (June 10) through Saturday in Blantyre, Malawi, titled “Assessment of NeuroAIDS in Africa.”
UNC’s Dr. Kevin R. Robertson, professor and director of neuropsychology in the School of Medicine’s department of neurology, will chair the conference as the study’s principal investigator.
Prior to the advent of antiretroviral drugs such as lamivudine and efavirenz in the United States, up to 20 percent of HIV-positive individuals developed some brain-related problems, said Robertson. Now that 20 different antiretrovirals are available in the United States, the rate and negative effects of neurological disease in these patients have been greatly reduced.
However, antiretrovirals often are not available to patients in resource-limited countries such as Malawi, a sub-Saharan African nation where one of the study sites is based.
“In the resource-limited world, we don’t know what the prevalence and incidence of these cognitive problems and dementia are,” Robertson said. “So the two goals of this study are first to establish the prevalence of neurological disease in HIV-positive patients in resource-limited countries, and then to see what improvement occurs with antiretroviral treatment.”
The HIV pandemic is the health-care crisis of our era, said Robertson. Statistics indicate that 40 million people worldwide are infected with HIV; last year, 3 million died and 5 million more were infected. About 30 percent of those infected with HIV live in sub-Saharan Africa, where more than one in 14 adults are infected.
Resource-limited settings with a high prevalence of HIV, such as sub-Saharan Africa, do not have antiretroviral medications to treat HIV, said Robertson. As a consequence of the immune system destruction caused from HIV infection, opportunistic infections can attack the brain and nervous system. In addition, HIV results in direct nervous system disease both in the brain (AIDS dementia complex) and elsewhere (peripheral neuropathy) that attacks the nerves in the feet. This results in considerable loss of productivity, then loss of income or crops and eventual inability to provide or care for children and families.
Since 1988, the UNC AIDS Neurological Center has been involved in many studies defining the natural history of AIDS dementia, investigating the impact of antiretrovirals on neurological functioning and clinical trials of new agents to treat HIV-related neurological dysfunction under the leadership of Dr. Colin Hall, professor and vice chairman of the department of neurology.
Robertson and Hall will spend approximately 10 percent of their time during the next five years working at the 12 International Neurological Study sites.
“We’re getting the opportunity to see these patients both before and after treatment,” Hall said. “This will enable us to determine which drugs are most beneficial.”
Drug treatment for the neurological study will take place within a separate NIH-funded clinical trial being conducted by UNC researchers in Malawi and South Africa to assess what antiretroviral regimens are best to initiate in resource-limited settings.
The UNC School of Medicine researchers involved in that project include Drs. Joseph Eron, associate professor; Charles van der Horst, professor; Myron Cohen, professor, chief of UNC’s Division of Infectious Diseases and director of UNC’s Center for Infectious Diseases; and Mina Housseinipour, assistant professor. Irving Hoffman, director of international operations in the Division of Infectious Diseases, is also a member of the research team.
Both studies are part of the national Adult AIDS Clinical Trials Group, which is funded through cooperative grants from the National Institutes of Health and the National Institute of Allergy and Infectious Diseases.
The 12 sites of the International Neurological Study are in Rio de Janeiro, Brazil; Porto Alegre, Brazil; Port-au-Prince, Haiti; Chennai, India; Pune, India; Blantyre, Malawi; Lilongwe, Malawi; Lima, Peru; Johannesburg, South Africa; Durban, South Africa; Chiang Mai, Thailand; and Harare, Zimbabwe.
School of Medicine contact: Stephanie Crayton-Robinson, (919) 966-2860 or scrayton@unch.unc.edu
News Services contact: Deb Saine, (919) 962-8415 or deborah_saine@unc.edu