BACKGROUND: Despite the recognized benefit of antiretroviral therapy (ART) for preventing and treating HIV, some studies have reported adverse birth outcomes with in utero ART exposure. We evaluated the effect of infant in utero HIV and ART exposure on preterm delivery (PTD), low birth weight (LBW), small for gestational age (SGA), and underweight for age (UFA) at 6 weeks. METHODS: We surveyed 6179 HIV-unexposed-uninfected (HUU) and 2599 HIV-exposed-uninfected (HEU) infants. HEU infants were stratified into 3 groups: ART, Zidovudine alone, and no antiretrovirals (None). The ART group was further stratified to explore pre- or postconception exposure. Multivariable logistic regression evaluated effects of HIV and ARV exposure on the outcomes. RESULTS: We found higher odds of PTD, LBW, SGA, and UFA in HEU than HUU infants. HEU in the None group (adjusted odds ratio [AOR], 1.9; 95% confidence interval [CI], 1.2-3.0) or those whose mothers initiated ART preconception (AOR, 1.7; 95% CI, 1.1-2.5) had almost twice the odds of PTD than infants whose mothers started ART postconception, but no increased odds for other outcomes. CONCLUSIONS: There was an association between preconception ART and PTD. As ART access increases, pregnancy registers or similar surveillance should be in place to monitor outcomes to inform future policy.