Safety of late in utero exposure to zidovudine in infants born to human immunodeficiency virus-infected mothers: Bangkok

Background. Short-course zidovudine (ZDV) given in the late antenatal perio d can reduce mother-infant human immunodeficiency virus (HIV) transmission by one half. Because this intervention is being implemented in developing c ountries, evidence of its safety is needed. Methods. In a randomized, double-blinded, placebo-controlled trial in Bangk ok, HIV-infected pregnant women received either ZDV (300 mg twice daily fro m 36 weeks' gestation until labor, then every 3 hours until delivery) or an identical placebo regimen. Infants were evaluated at birth and at 1, 2, 4, 6, 9, 12, 15, and 18 months of age. Growth, clinical events, and hematolog ic and immunologic measurements were compared between treatment groups. Results. Of the 395 children born (196 in ZDV group and 199 in placebo grou p), 330 were uninfected, 55 were infected, and 10 had indeterminate infecti on status. Overall, 319 children (81%) completed 18 months of follow-up, an d 14 (4%) died before 18 months of age. Among uninfected children, the mean hematocrit was lower in the ZDV group at birth (49.1% vs 51.5%) but not at later ages; mean weight, height, head circumference, and CD4(+) and CD8(+) T lymphocyte counts were similar in both groups at all ages. Five uninfect ed children in the ZDV group but only one in the placebo group had a febril e convulsion. No other signs suggestive of mitochondrial dysfunction and no tumors were observed. Among infected children, an estimated 62% in the ZDV group and 77% in the placebo group survived free of Centers for Disease Co ntrol and Prevention class C disease during the 18-month follow-up. Conclusions. No significant adverse events were associated with short-cours e ZDV during 18 months of follow-up in this population.