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Commentary & Opinion

Researchers, Communities, Officials Need to Collaborate on HIV Prevention Trials, Viewpoint Piece Says

October 24, 2005

Although it was an "unusual circumstance" when Cambodian Prime Minister Hun Sen last year ordered a stop to a planned human clinical trial of Gilead Science's antiretroviral drug Viread, he showed "a genuine concern for issues that remain challenging not only in Cambodia, but wherever a prevention trial is being considered in a population with limited access to basic health services," Kimberly Page-Shafer of the Center for AIDS Prevention Studies at the University of California-San Francisco and colleagues from Cambodia's Ministry of Health and the University of New South Wales write in a Lancet "Viewpoint" piece (Page-Shafer et al., Lancet, 10/22). In March 2004, NIH awarded a $2.1 million grant to UCSF researchers to test Viread in 960 Cambodian women. The medication, which is known generically as tenofovir, has been shown to boost immune response and reduce viral levels in the bloodstreams of patients who are resistant to other antiretroviral drugs. The study, funded by NIH and the Bill & Melinda Gates Foundation, was a collaborative effort among Cambodia's health ministry, UCSF and UNSW. Health Minister Nuth Sokhom in August 2004 said that Hun Sen told him to stop the planned trials because of concern "about the effect on the Cambodian people and on the human values and rights" (Kaiser Daily HIV/AIDS Report, 8/12/04).

"Frank Discussions" Needed, Authors Say
"Although we remain confident that our trial planning followed, and in many respects went well beyond, accepted ethical standards, we have absolutely no doubt that ... there were areas in which the management of interactions with potential participants and their representatives could have been substantially improved," the authors write. In establishing new studies "across cultures," researchers must demostrate "special efforts and innovation in communication, and there is little in the way of textbooks and guidelines to show the way to achieve these goals," according to the authors. Therefore, "[c]ommunities, governments, researchers and funding agencies should come together for frank discussions about these issues if we are to be able to test critical approaches to prevent the transmission of what is still regarded as the greatest global threat to human health," they conclude (Lancet, 10/22).

Back to other news for October 24, 2005

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Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork.org/dailyreports/hiv. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service of the Kaiser Family Foundation, by The Advisory Board Company. © 2005 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.



  
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This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.
 
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