15 Month follow up of African children following vaginal cleansing with benzalkonium chloride of their HIV infected mothers during late pregnancy and delivery.

OBJECTIVES: To study mother to child HIV-1 transmission (MTCT) and infant mortality following benzalkonium chloride (BC) disinfection. METHODS: A randomised, double blind phase II placebo controlled trial. Women testing positive for HIV-1 infection in prenatal care units in Abidjan, Côte d'Ivoire, and Bobo-Dioulasso, Burkina Faso, from November 1996 to April 1997 were eligible, with their informed consent. Women self administered daily a vaginal suppository of 1% BC (53) or matched placebo (54) from 36 weeks of pregnancy, plus a single dose during labour. The neonate was bathed with 1% BC solution or placebo within 30 minutes after birth. MTCT rate was assessed based on repeated polymerase chain reaction (PCR) and serology results. For the present analysis, children were followed up to 15 months. RESULTS: A total of 107 women were enrolled. Of 103 eligible liveborn children, 23 were HIV infected, 75 uninfected, and five of indeterminate status. MTCT transmission rate was 24.2% overall (95% confidence interval (CI): 14.3% to 30.4%). On an intent to treat basis, the transmission rate did not differ between the two groups (23.5%, CI 13.8 to 38.5, in the BC group and 24.8%, CI 15.0 to 39.6, in the placebo group at 15 months). Similarly, there was no difference in mortality at 15 months (22.9%, CI 13.7 to 36.9, in the BC group and 16.5%, CI 9.0 to 29.4, in the placebo group). CONCLUSION: This analysis failed to suggest any benefit of BC disinfection on mother to child HIV transmission or perinatal and infant mortality.

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

OBJECTIVES: To study the tolerance and acceptability in Africa of a perinatal intervention to prevent vertical HIV transmission using benzalkonium chloride disinfection. DESIGN: A randomized, double blinded phase II trial. SETTING: Prenatal care units in Abidjan (Côte 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 30. The incidence of genital signs and symptoms in the women and cutaneous or ophthalmological 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 Africa. Its efficacy in preventing vertical HIV transmission remains to be demonstrated.

Haematological characteristics and HIV status of pregnant women in Abidjan, Côte d'Ivoire, 1995-96.

To describe the haematological profile of pregnant women and to compare these characteristics according to HIV serostatus in Abidjan, Côte d'Ivoire, a cross-sectional study was made in the context of a research intervention programme to reduce mother-to-child transmission (MTCT) of HIV (ANRS 049 trial). HIV testing was systematically proposed to pregnant women attending the mother and child health clinic of a community health centre. Blood samples were tested for HIV antibodies using Genelavia and Peptilav. The haematological parameters were measured with a Coulter counter. From May 1995 to March 1996, 1646 pregnant women accepted HIV testing and had a full blood count available. The prevalence of HIV infection was 12.0% (n = 197). The prevalence of anaemia (haemoglobin [Hb] < 11 g/dL) was 70.1%, n = 1155 (95% confidence interval 68-72%) and significantly higher in HIV+ (81.7%, n = 161) than in HIV- women (68.9%, n = 994) (P < 0.001). Severe anaemia (Hb < 7 g/dL) was present in 1.9% of the women (n = 31), 4.6% (n = 9) in HIV+ and 1.5% (n = 22) in HIV- women (P < 0.001). HIV infection, primigravidae and secundigravidae were factors independently associated with anaemia. Anaemia was highly prevalent in this population while severe anaemia was rare. HIV infection was a contributor to anaemia in pregnancy. As zidovudine, with its known haematological toxicity, has recently been introduced to prevent MTCT of HIV in developing countries, screening HIV+ women for severe anaemia is necessary.