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To evaluate independent contributions of maternal factors to adverse pregnancy outcomes (APO) in HIV-infected women receiving antiretroviral therapy (ART).Risk factors for preterm birth (< 37 weeks gestation), low birth weight (LBW) (< 2500 g), and intrauterine growth retardation (IUGR) (birth weight < 10th percentile for gestational age) examined in 497 HIV-infected pregnant women enrolled in PACTG 185, a perinatal clinical trial.HIV RNA copy number, culture titer, and CD4 lymphocyte counts were measured during pregnancy. Information collected included antenatal use of cigarettes, alcohol, illicit drugs; ART; obstetric history and complications.Eighty-six percent were minority race/ethnicity; 86% received antenatal monotherapy, predominantly zidovudine (ZDV), and 14% received combination antiretrovirals. Preterm birth occurred in 17%, LBW in 13%, IUGR in 6%. Risk of preterm birth was independently associated with prior preterm birth [odds ratio (OR) 3.34;P < 0.001], multiple gestation (OR, 6.02;P = 0.011), antenatal alcohol use (OR, 1.91;P = 0.038), and antenatal diagnosis of genital herpes (OR, 0.24;P = 0.022) or pre-eclampsia (OR, 6.36;P = 0.025). LBW was associated with antenatal diagnosis of genital herpes (OR, 0.08;P = 0.014) and pre-eclampsia (OR, 5.25;P = 0.049), and baseline HIV culture titer (OR, 1.41;P = 0.037). IUGR was associated with multiple gestation (OR, 8.20;P = 0.010), antenatal cigarette use (OR, 3.60;P = 0.008), and pre-eclampsia (OR, 12.90;P = 0.007). Maternal immune status and HIV RNA copy number were not associated with APO.Risk factors for APO in antiretroviral treated HIV-infected women are similar to those reported for uninfected women. These data suggest that provision of prenatal care and ART may reduce APO.