Short-course oral zidovudine for prevention of mother-to-child transmission of HIV-1 in Abidjan, Cote d'Ivoire: a randomised trial

Background In Africa, the risk of mother-to-child transmission of HIV-1 inf ection is high. Short-course perinatal oral zidovudine might decrease the r ate of transmission, We assessed the safety and efficacy of such a regimen among HIV-1-seropositive breastfeeding women in Abidjan, Cote d'Ivoire. Methods From April, 1996, to February, 1998, all consenting, eligible HIV-1 -seropositive pregnant women attending a public antenatal clinic in Abidjan were enrolled at 36 weeks' gestation and randomly assigned placebo or zido vudine (300 mg tablets), one tablet twice daily until the onset of labour, one tablet at onset of labour, and one tablet every 3 h until delivery. We used HIV-1-DNA PCR to test the infection status of babies at birth, 4 weeks , and 3 months. We stopped the study on Feb 18, 1998, when efficacy results were available from a study in Bangkok, Thailand, in which the same regime n was used in a non-breast-feeding population. Findings 280 women were enrolled (140 in each group). The median duration o f the prenatal drug regimen was 27 days (range 1-80) and the median duratio n of labour was 7-5 h. Treatment was well tolerated with no withdrawals bec ause of adverse events. All babies were breastfed. Among babies with known infection status at age 3 months, 30 (26.1%) of 115 babies in the placebo g roup and 19 (16.5%) of 115 in the zidovudine group were identified as HIV-1 infected, The estimated risk of HIV-1 transmission in the placebo and zido vudine groups were 21.7% and 12.2% (p=0.05) at 4 weeks, and 24.9% and 15.7% (p=0.07) at 3 months. Efficacy was 44% (95% CI -1 to 69) at age 4 weeks an d 37% (-5 to 63) at 3 months, Interpretation Short-course oral zidovudine was safe, well tolerated, and d ecreased mother-to-child transmission of HIV-1 at age 3 months. Substantial efforts will be needed to ensure successful widespread implementation of s uch a regimen.