Safety and acceptability of vaginal disinfection with benzalkonium chloride in HIV infected pregnant women in west Africa:: ANRS 049b phase II randomised, double blinded placebo controlled trial

Objectives: To study the tolerance and acceptability in Africa of a perinatal intervention to prevent vertical HIV transmission using benzalkonium chloride disinfection. Design: A randomised, double blinded phase II: trial. Setting: Prenatal care units in Abidjan (Cote d'Ivoire) and Bobo-Dioulasso (Burkina Faso). Patients: Women accepting testing and counselling who were seropositive for HIV-1 and under 37 weeks of pregnancy were eligible. A total of 108 women (54 in each group) enrolled from November 1996 to April 1997, with their informed consent. Intervention: Women self administered daily a vaginal suppository of 1% benzalkonium chloride or matched placebo from 36 weeks of pregnancy, and a single intrapartum dose. The neonate was bathed with 1% benzalkonium chloride solution or placebo within 30 minutes after birth. Main outcome measures: Adverse events were recorded weekly with a questionnaire and speculum examination in women through delivery, and examination of the neonate through day ophthalmologi-30. The incidence of genital signs and symptoms in the women and cutaneous or o cal events in newborns 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. In women, the most frequent event was leucorrhoea; the incidence of adverse events did not differ between treatment groups. In children, the incidence of dermatitis and conjunctivitis did not differ between the benzalkonium chloride and placebo groups (p=0.16 and p=0.29, respectively). Conclusion: Vaginal disinfection with benzalkonium chloride is a feasible and well tolerated intervention in west Ati ica. Its efficacy in preventing vertical HIV transmission remains to be demonstrated.