NEWS

Doctors announce first NIH-funded AIDS treatment research in Africa

By DAVID WILLIAMSON
UNC News Services

CHAPEL HILL -- After overcoming numerous financial and governmental obstacles -- and working together -- doctors have enrolled five people infected with HIV, the virus that causes AIDS, in the first National Institutes of Health-funded AIDS treatment research study in Africa.

When those patients complete four weeks of therapy successfully, another 15 will be enrolled at a Johannesburg, South Africa, clinic. Eventually, 355 more patients at multiple clinics in the United States will participate in the study, which will examine strong antiretroviral therapy and determine if doctors can rely on patients to take medicines on their own.

NIH has funded several previous HIV prevention trials in Africa but no treatment studies of HIV-infected patients there, said Dr. Charles van der Horst, professor of medicine at the University of North Carolina at Chapel Hill and visiting professor at the University of the Witwatersrand. He and Dr. Ian Sanne, director of the Witwatersrand’s AIDS Clinical Trials Unit, began a partnership between UNC and the South African university to develop and expand HIV clinical research on the continent hardest hit by the deadly pandemic.

"This is an enormous milestone," van der Horst said. "It also is a wonderful feeling to witness the excitement on patients’ faces on the enrollment day."

Said Sanne, "We are very grateful for the support of the NIH as well as the South African government."

Named AACTG 5073, the 48-week trial will compare the effectiveness of antiretroviral treatment given once a day with treatment given twice daily, van der Horst said. Since compliance with prescribed dosing is a major problem with HIV-infected people in the United States, researchers also will determine if having medical staff watch patients take pills results in better health than allowing them to do it at home.

If patients do not take the drugs correctly, the virus can mutate, or change, and then the treatments will no longer work, he said. That mutant virus also can be transmitted from mother to child at birth and between sexual partners making it a public health problem and not just an individual patient problem.

"One of the ways to ensure that patients are taking their medicines is to observe them taking each dose, which is called ‘directly observed therapy’ or ‘DOTS,’" van der Horst said. "This theoretically makes sense, but it must be proven to work and be cost effective."

Antiretroviral medications to be given in combination are Kaletra (lopinavir/ritonavir) by Abbott, Zerit (stavudine extended release) by Bristol Myers Squibb and Coviracil (emtricitabine) by Triangle, he said. During drug treatment, doctors will regularly monitor virus levels in patients’ blood. After the 48 weeks, participants will be followed medically and treated free for four years.

"The National Institutes of Health said we had to have post-trial treatment but gave us no standards for what treatment should be or for now long and said we could not use NIH dollars to pay for medical care," van der Horst said. "As a result, we not only had to write our own standards and get approval from both governments, but we also had to raise enough money through donations for treatment and insurance. It was a tremendous amount of work."

About 15 percent of the world’s AIDS cases are in South Africa, which has about 4.7 million infected people, the physician said. At least 25 percent of them need treatment immediately. On Aug. 8, the South African government announced a historic program to begin treatment, but many hurdles remain before full implementation.

An estimated 30 million people throughout Africa carry the virus.

"Research of this kind is critical to inform policy, especially now when our government is assessing the provision of antiretrovirals," said Dr. Nono Simelela, director of South Africa’s national AIDS program. "Any treatment program must be grounded on good research such as this study."

"The National Institutes of Health is committed to fostering HIV prevention and treatment research throughout sub-Saharan Africa," said Dr. Edmund Tramont, director of the National Institute of Allergy and Infectious Diseases’ AIDS division. "One mechanism to accomplish this is through productive collaborations between U.S. academic medical centers and partners in Africa.

"The collaboration between the University of North Carolina faculty and the faculty at the University of the Witwatersrand has been very productive, leading to multiple projects funded by the NIH," Tramont said.

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Note: Reach van der Horst via cell at (919) 270-0816, 942-3162 (home) or cvdh@med.unc.edu. Sanne can be reached at 27 11 717 2810 or 27 82 457 5223 or isanne@witshealth.co.za

Contact: David Williamson, (919) 962-8596