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.

Serological diagnosis of human immuno-deficiency virus in Burkina Faso: reliable, practical strategies using less expensive commercial test kits.

Reported are the results of a cross-sectional survey in Burkina Faso to identify reliable, practical strategies for the serological diagnosis of HIV-1 and/or HIV-2 infections, using less-expensive commercial test kits in various combinations, as an alternative to the conventional Western blot (WB) test, which costs US$ 60. Serum samples, collected from blood donors, patients with acquired immunodeficiency syndrome (AIDS) and pregnant women, were tested between December 1995 and January 1997. Twelve commercial test kits were available: five Mixt enzyme-linked immunosorbent assays (ELISA), three Mixt rapid tests, and four additional tests including monospecific HIV-1 and HIV-2 ELISA. The reference strategy utilized a combination of one ELISA or one rapid test with WB, and was conducted following WHO criteria. A total of 768 serum samples were tested; 35 were indeterminate and excluded from the analysis. Seroprevalence of HIV in the remaining 733 sera was found to be 37.5% (95% confidence interval: 34.0-41.1). All the ELISA tests showed 100% sensitivity, but their specificities ranged from 81.4% to 100%. GLA (Genelavia Mixt) had the highest positive delta value, while ICE HIV-1.0.2 (ICE) produced the most distinct negative results. Among the rapid tests, COM (CombAIDS-RS) achieved 100% sensitivity and SPO (HIV Spot) 100% specificity. Various combinations of commercial tests, according to recommended WHO strategies I, II, III, gave excellent results when ICE was included in the sequence. The best combination of tests for strategy II, which achieved 100% sensitivity and specificity, was to use ICE and COM, the cost of which was US$ 2.10, compared with US$ 55.60 for the corresponding conventional strategy. For strategy III, the best combination, which achieved 100% sensitivity and specificity, was to use ICE, ZYG (Enzygnost Anti HIV-1/HIV-2 Plus) and COM, the cost of which was US$ 2.90 (19.2 times lower than the corresponding strategy requiring WB). No rapid test combination showed 100% sensitivity and specificity. Our results indicate that the serodiagnosis of HIV in Burkina Faso is possible by using reliable, less-expensive strategies which do not require Western blot testing. Moreover, there is a choice of strategies for laboratories working with or without an ELISA chain.

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.