The effects of zidovudine in the subset of infants infected with human immunodeficiency virus type-1 (Pediatric AIDS Clinical Trials Group Protocol 076)

Objective: To describe the effect of zidovudine on human immunodeficiency v irus type I (HIV-1) and on the course of disease in infants who became infe cted while they and their mothers received zidovudine preventive therapy or placebo in Pediatric AIDS Clinical Trials Group Protocol 076. Study design: Observational substudy of a multicenter, randomized, double-b lind, placebo-controlled trial. Methods: We compared the progression of disease, timing of HIV-1 transmissi on, and the plasma HIV-1 RNA level in infected infants of mother-infant pai rs who were randomly assigned to receive zidovudine (n = 14) or placebo (n = 43). The development of genotypic zidovudine resistance was assessed amon g infected infants in the zidovudine treatment group. Results: In this limited study, zidovudine therapy during pregnancy and lab or and in the neonatal period for 6 weeks failed to have a major effect on rapid progression of disease, timing of transmission, and viral replication in HIV-infected infants. When the zidovudine treatment regimen failed to p revent maternal-infant transmission of HIV-1, resistance to zidovudine did not develop during study treatment. Conclusions: Our study supports the safety of zidovudine use in pregnancy a nd in the newborn period but demonstrates the continued need for more poten t antiretroviral treatment of the infected infant.