Activity Description
At the request of the National Institutes of Health (NIH), the Institute of Medicine (IOM) conducted an independent review of the HIVNET 012 perinatal HIV prevention trial. The HIVNET 012 trial was a randomized, controlled study conducted in Uganda that compared the safety and efficacy of two short-course regimens of antiviral drugs, nevirapine and zidovudine, in preventing transmission of HIV from HIV-infected mothers to their infants.
This trial found that the nevirapine regimen significantly reduced the risk of perinatal HIV transmission when compared to the zidovudine regimen. Economic analyses also showed that the nevirapine regimen was inexpensive and cost-effective relative to other regimens. This study provided the foundation that many developing countries used to initiate programs to prevent perinatal transmission of HIV.
The NIH asked the IOM to review methodological and data interpretation issues related to protocol design, data collection, recordkeeping, quality control, and analysis. The committee assessed the impact of these issues on the validity of overall findings and conclusions of the trial.