Vaginal disinfection with benzalkonium chloride and vertical transmission of HIV-1 in West Africa: diatrame ANRS 049b trial

Abstract

Objectives To study in Africa a perinatal intervention to prevent critical HIV transmission using Benzalkonium chloride (BC) disinfection. Methods A randomized, double blinded phase II trial, looking at safety and acceptability of BC as primary objective, and vertical transmission as secondary objective. Women accepting testing and counseling in prenatal care units in Abidjan (Côte d'Ivoire) and Bobo-Dioulasso (Burkina Faso), who were infected by HIV-1 and under 37 weeks of pregnancy were eligible. A total of 108 women (54 in each group) were enrolled from November 1996 to April 1997, with their informed consent. Women self-administered daily a vaginal suppository of 1% BC or matched placebo from 36 weeks of pregnancy, and a single intrapartum dose. The neonate was bathed with 1% BC solution or placebo within 30 minutes after birth. Maternal and neonatal adverse events (self-reported and by clinical exam) in the first four weeks and vertical transmission rates measured after 15 months of follow-up (serology and PCR) were compared between groups on an intent-to-treat basis. Results The median duration of prepartum treatment was 21 days (range 0-87 days). Compliance was 87% for prepartum and 69% for intrapartum treatment, and 88% for the neonatal bath, without differences between the two groups. Intervention was well tolerated (P. Msellati et al., Sex. Transm. Inf 1999: 75 (December)). Vertical transmission rate was 21.4% overall (95% confidence interval: 13.4-29.3%, 110 livebirths, 22 infected children, 81 uninfected and 7 of unknown status). It was 21.2% in BC group and 21.6% in placebo group. Vaginal disinfection with BC is a feasible and well-tolerated intervention in West Africa. Its efficacy in preventing vertical HIV transmission cannot be demonstrated in this trial.