No irregularities in nevirapine study

Keith Alcorn
Estimated reading time 1 minutes
This article is more than 22 years old.

South Africa’s Cape Times has reported that a National Institute for Allergy and Infectious Diseases investigation of the HIVNET 012 study has turned up no irregularities in the documentation of adverse events and other events in the study. However, the final report is likely to be kept under wraps for several months.

HIVNET 012 showed that a single dose of nevirapine during delivery and for the infant reduced the risk of HIV transmission compared to a short course of AZT.

Glossary

pilot study

Small-scale, preliminary study, conducted to evaluate feasibility, time, cost, adverse events, and improve upon the design of a future full-scale research project.

 

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

mother-to-child transmission (MTCT)

Transmission of HIV from a mother to her unborn child in the womb or during birth, or to infants via breast milk. Also known as vertical transmission.

In March of this year an investigation was set up following the discovery of potential problems in record keeping that led the US Food and Drug Administration to refuse to license nevirapine for use in prevention of mother to child transmission in the US.

The South African government subsequently called into question the future of a pilot study of nevirapine, and South Africa’s Medicines Control Council announced that it would be reviewing nevirapine’s license. The MCC will review the report by January.

The findings should remove the last procedural obstacle to more widespread provision of nevirapine treatment for mothers with HIV in South Africa.

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