Articles on Nevirapine Trial Might Threaten Drug's Use Among Newborns, South African AIDS Experts Say
January 7, 2005
A recent series of Associated Press articles "criticizing the conduct" of a trial of the antiretroviral drug nevirapine among pregnant women in Uganda is "threatening to undermine" the drug's use to prevent infection among newborn infants in developing countries, according to some South African HIV/AIDS experts, BMJ reports (Roehr, BMJ, 1/8). The articles concerned an NIH-funded trial that began in 1997 to study the use of nevirapine in single doses among HIV-positive pregnant women in Uganda to determine the drug's ability to prevent vertical HIV transmission. The initial results showed that the drug prevented HIV transmission to newborns in as many as half of births. By early 2002, medical safety specialists and auditors with NIH as well as the drug's manufacturer Boehringer Ingelheim all cited "widespread" problems with the research in Uganda -- including a failure to receive participants' consent about changes in the study, administration of incorrect doses, and delays in reporting and underreporting of fatal and life-threatening reactions to the drug. Because of the reported problems, NIH suspended the research from spring 2002 to summer 2003 in order to review the trial and take corrective steps. Last month, National Institute of Allergy and Infectious Diseases Division of AIDS Director Dr. Edmund Tramont also admitted to rewriting a safety report on the use of nevirapine in pregnant women in order to change its conclusions and remove negative information about the drug. However, NIAID in a recent Q & A document regarding the trial said that nevirapine is a "safe and effective" treatment to reduce the risk of vertical HIV transmission and that reviews of the study data "have found only a very small number of serious adverse reactions that potentially might be due to nevirapine" (Kaiser Daily HIV/AIDS Report, 1/5). NIH in July 2004 asked the Institute of Medicine to conduct a review of the Ugandan trial, and its results are expected in March.
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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.