The following abbreviated abstract and table are from a paper published in JAMA (JAMA. 2001; 285:2083-2093)entitled "Lamivudine-Zidovudine Combination for Prevention of Maternal-Infant Transmission of HIV-1".

ContextZidovudine reduces maternal-infant transmission of human immunodeficiency virus 1 (HIV-1) infection by two-thirds. Combination antiretroviral therapies are potentially more effective prevention.

ObjectivesTo assess the safety of perinatal lamivudine-zidovudine therapy, especially in children, and its effects on viral load, acquisition of drug resistance, and maternal-infant transmission of HIV-1.

Design and Settingan open-label, nonrandomized intervention trial conducted in the context of an ongoing observational cohort study in 48 sites in France.

PatientsA total of 452 HIV-1-infected pregnant women were enrolled as the study cohort; controls consisted of 910 pregnant women who had received zidovudine monotherapy as standard care.

Main Outcome MeasuresHIV-1 infection status and tolerance of therapy in children through age 18 months; maternal plasma HIV-1 RNA levels through 6 weeks after delivery.

Table 4. Neonatal and Selected Follow-up Characteristics of Children Lamivudine-Zidovudine Zidovudine Study Cohort Control Cohortt P Characteristics (n = 452) (n = 910) Value Stillbirths, % 0.2 0.5 67 Birth weight, median (range), g 31 10 (1470-4930 3100 (700-4770) .83 Length, median (range), cm 49 (41-55) 49 (35-57) 73 Head circumference, median (range), cm 34 (27-39) 34 (22-40) 15 Small for gestational age, % 17 17 .93 Gestational age, median (range), wk 39 (32-42) 39 (26-44) 44 Premature (