Ethical Challenges Posed by Zidovudine Treatment to Reduce Vertical Transmission of HIV

In February 1994 the Data and Safety Monitoring Board of the National Institute of Allergy and Infectious Diseases recommended the interruption of a clinical trial designed to determine whether the administration of zidovudine to pregnant women infected with the human immunodeficiency virus (HIV) and to their newborns could reduce the rate of vertical viral transmission. Given the responsibilities of the Data and Safety Monitoring Board, there was no alternative. The difference in the rate of transmission between those receiving zidovudine and those receiving placebo was statistically significant (P = 0.00006). Women who received zidovudine had a transmission rate of 8.3 . . .