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Institute of Medicine news: Review of HIVNET 012 study

WASHINGTON -- A Ugandan drug trial's findings that the AIDS medication nevirapine is effective and safe in preventing HIV transmission from mother to unborn child during birth were well-supported, according to a new, independent analysis by the Institute of Medicine of the National Academies. The IOM's analysis of the design and methodology of the 1997 drug study in Uganda, called HIVNET 012, determined that policy-makers and other scientists can rely on the resulting data and conclusions, despite some flaws in record keeping and procedural issues.

"The data from the HIVNET 012 study, which showed that nevirapine effectively prevents many infants from contracting HIV from their infected mothers, are sound and reliable," said James Ware, chair of the committee that wrote the report, and professor of biostatistics, Harvard School of Public Health, Boston. "None of the shortcomings that we discovered upon reviewing the data and conducting our own original analysis of source documents indicates a need to retract or discount the study's findings. Our confidence in the trial's data and findings is based on several factors, including evidence that the study's design was both scientifically sound and ethically implemented, that participants adhered well to the treatment regimens, and that a high percentage of participants remained in the study so that the effectiveness and safety of the drug could be thoroughly assessed."

Previous evaluations of HIVNET 012 left lingering uncertainties about the trial's results, suggesting the need for a definitive, objective review. The IOM focused on the scientific validity of the study's conclusions based on a close examination of how researchers from Johns Hopkins University and Uganda's Makerere University conducted the trial. This independent review was requested and funded by the National Institutes of Health, which also funded the original trial in Uganda.

The committee did not evaluate the trial's oversi
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Contact: Christine Stencel
news@nas.edu
202-334-2138
The National Academies
8-Apr-2005


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