HIVNET 012 perinatal HIV prevention trial praised by IOM

The Institute of Medicine (IOM) of the National Academies of Sciences in the autumn of 2004 was asked by the NIH to review the HIVNET 012 perinatal HIV prevention trial and provide an assessment of the validity of the study results.

The NIH asked them to "address the methodolog [ies] and data — related to protocol design, data collection, record keeping, quality control, and analysis" and address the impact of these issues on the validity of the overall findings and the conclusions of the trial. The committee was to answer a series of specific questions listed in the report, which is available online.

The NIH review of the report is positive and they are satisfied with the thorough and complete way in which the IOM performed its assessment.

The findings of the report by the IOM report are in agreement with previous reviews of the HIVNET 012 study and says that the data are sound, presented in a balanced manner and can be relied upon for scientific and policy-making purposes.

The committee devoted one of the five chapters of its report to ethical issues involved in the performance of this study and found no ethical concerns about the design or implementation of the study, that would justify excluding its findings from use in scientific and policy deliberations.

It is expected by the NIH that the findings by the IOM will restore confidence in the validity of the conclusions of this study, allow the controversy surrounding this issue to subside, and facilitate policy decisions that seek to promote the health of newborns at risk of HIV infection.

NIH has thanked the committee members and staff of the IOM for the scholarly report.