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International audience; 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.

Background: There is no data on long-term benefit of once-a-day antiretroviral therapy (ART) with combination of DDI, 3TC and EFV to allow its use in future therapeutic strategies.Objectives: To assess 24-month immuno-virological, adherence, tolerance, and effectiveness of a once-a-day ART with DDI, 3TC and EFV.Methods: A phase 2 open trial including 51 children aged from 30 months to 15 years, monitored a once-a-day regimen for 24 months from 2006 to 2008 in the Departement de Pediatrie du CHUSS, at Bobo-Dioulasso in Burkina Faso. We tested immunological and virological response, adherence, tolerance and resistance of the treatment.Results: Children with CD4 >25% at 24 months were 67.4% (33/49) CI 95% [54%, 80%].The proportion of children with viral plasma RNA 95% over the 24 months. Drugs were well tolerated.Conclusions: Given the limited number of antiretroviral drugs available in Africa and the inadequacy of laboratory monitoring in support program, once-a-day treatment and especially the DDI-based combination strategies could be an attractive operational option.Key words: once-a-day therapy, Didanosine, Lamivudine, and Efavirenz, child.

This study sought to identify the factors associated with failure to return for HIV post-test counseling in pregnant women in Kigali (Rwanda). In the context of a study on the impact of HIV infection on pregnancy HIV-1-antibody testing was offered to all pregnant women attending the antenatal clinic of the Centre Hospitalier de Kigali from July 1992 to August 1993. Pre-test counseling was performed after verbal informed consent was obtained. Two weeks later the authors formally enrolled all HIV-positive women and a corresponding number of HIV-negative women in a cohort. At this visit post-test counseling was given to those wishing to be informed of their HIV serostatus. Level of knowledge about modes of HIV transmission and condom use were recorded. Four months after delivery another interview was conducted to determine the proportion of women who used condoms regularly. A total of 1233 pregnant women were screened. The HIV seroprevalence was 34.4% (95% confidence interval [CI] 31.7-37.1); 271 (63.9%) out of 424 HIV-positive and 577 (71.3%) out of 809 HIV-negative women asked for their HIV serostatus (p = 0.008). In multivariate analysis the only variable significantly associated with failure to return for post-test counseling was a positive HIV test result (odds ratio 0.7; 95% CI 0.5-0.9; p = 0.009) independently of obstetrical history and socioeconomic characteristics. Among the 848 women who had post-test counseling 50.9% of the HIV-positive women and 94.6% of the HIV-negative women stated that they planned to inform their partner of their serostatus (p = 0.0001). More than 95% of the women interviewed knew about sexual and parenteral transmission of HIV but half were unaware of mother-to-child transmission. More than 80% of the women had seen a condom before but 14% only had used it at least once. Among women who were sexually active four months after delivery 8.8% of the HIV-positive and 3.9% of the HIV-negative women reported using a condom (p = 0.04). Innovative approaches for HIV testing and counseling programs are needed and the importance of psychosocial and cultural factors associated with HIV testing should be emphasized in African populations. (authors)

OBJECTIVE: To ascertain the field acceptability and effectiveness of the routine utilization of zidovudine in reducing mother-to-child transmission (MTCT) of HIV in breastfed children after a randomized clinical trial demonstrated its efficacy in Cote d'Ivoire and Burkina Faso. METHODS: Pregnant women aged 18 years or older, who had confirmed HIV-1 infection, haemoglobinemia greater than 7 g/dl were enrolled in an open label cohort at 36-38 weeks' gestation to receive an oral short course of zidovudine. Paediatric HIV infection was defined as a positive HIV-1 polymerase chain reaction, or if aged 15 months or older, a positive HIV serology. RESULTS: The acceptability of HIV pretest counselling was significantly higher in the cohort (90.3%) than in the trial (83.7%) (P < 0.001), but the return rate for HIV test results and for inclusion was low. A similar proportion of women accepted starting zidovudine in the cohort, 30.4% compared with 27.3% in the trial (P = 0.13). The proportions of women who took more than 80% of the expected zidovudine regimen were 81.8% before labour, 86.7% during labour, and 88.1% during the postpartum period, compared with those observed during the trial, 78.1, 81.1, and 85%, respectively. The MTCT probability at age 15 months was 19.6% in the cohort (n = 185) versus 21.2% in the trial (P = 0.52). CONCLUSION: The major drawback with the implementation of a short zidovudine regimen to reduce MTCT is HIV counselling and testing procedures. For women who consent, zidovudine is well accepted and efficacious under routine circumstances.

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 (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 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.

Especially in developing countries HIV prevalence estimates in the general population are based upon the prevalence observed through sentinel surveillance in antenatal centers. Pregnant women are therefore considered to be representative of all women of childbearing age. However HIV-1 prevalence in the general population may be underestimated when based upon such surveillance because studies have shown that HIV infection may impair female fertility causing HIV-infected women to visit antenatal centers less often than do other women. Prevalences assessed at antenatal centers therefore need to be adjusted. Nicoll et al.s method of adjusting by estimating a summary relative inclusion ratio (RIR) was applied to Abidjan Cote dIvoire. The RIR was used upon data on female fertility by HIV status for 5483 pregnant women who agreed to be tested for HIV between 1995 and 1997 in 3 antenatal centers in Yopougon district and found to be readily applicable in African countries although it is important to consider the age structure of the population in antenatal centers and to stratify that adjustment by age. The only data needed for such an adjustment are age number of live births HIV serostatus for women entering the sentinel center and if possible age at first sexual intercourse and the age structure of the community considered.

The reproductive histories of 1201 consecutive women attending a prenatal clinic in Abidjan Ivory Coast in 1997 were investigated to determine whether HIV-infected women become pregnant less often than HIV-negative women. This issue is important because if HIV-positive women have fewer pregnancies or more miscarriages than other women then women who visit antenatal clinics are not representative of all women of childbearing age and HIV prevalence is underestimated at these centers. All women were unaware of their HIV status at study entry. 169 women (14.3%) were HIV-positive but it was not possible to determine whether the pregnancies occurred before or after infection. The mean age at first coitus was 16 years among HIV-positive and 17 years among HIV-negative women. The mean number of pregnancies was higher among HIV-positive women under 20 years of age than HIV-negative women of this age (2.1 vs. 1.7) but this trend was reversed from age 25 years onward (4.2 vs. 4.7). The interval between the last two pregnancies was longer among HIV-infected women than uninfected women (36.4 vs. 33 months). The gap was greatest among women 25-29 years of age (51.8 vs. 35.7 months). In multivariate analysis after adjustment for age last pregnancy outcome duration of postpartum amenorrhea use of contraceptives during this interval marital status and educational level HIV infection significantly delayed the occurrence of the current pregnancy (Cox model hazard ratio 0.83; 95% confidence interval 0.69-0.99). Since HIV infection appears to compromise physiologic ability to become pregnant HIV prevalence assessed at antenatal centers should be adjusted for the fertility differences between HIV-positive and HIV-negative women.

Before implementation of a tolerance and efficacy trial of zidovudine (ZDV) in Abidjan Ivory Coast the acceptability of HIV screening was probed among women attending the Yopougon Health Center for their first prenatal visit in 1996-97. Of the 2219 prenatal clients who were eligible for AZT 395 (17.8%) refused HIV testing--primarily because of fear of the result. Of the 1824 women who consented to testing 279 (15.3%) were HIV-positive (249 for HIV-1 21 for HIV-2 and 9 with dual reactions). 204 HIV-positive women returned for their test result. Of these women 3 refused the confirmation test and 29 were lost to follow-up after the second test leaving 172 women for pre-inclusion. However 101 of these women were subsequently excluded for reasons including return visit too late in pregnancy for AZT planned delivery outside of Abidjan change of mind and loss to follow-up before formal inclusion. Thus only 71 women received the trial treatment. The only significant difference between these 71 women and those who did not complete the selection process was that the former women were older (mean age 26 years) than the latter (mean age 24 years). The finding that it was necessary to perform HIV tests in 1824 women to recruit 71 women for a clinical trial of ZDV indicates a need for IEC campaigns aimed at women of childbearing age about maternal-child HIV transmission and its prevention.

The evolution of genomic RNA of human immunodeficiency virus type 1 (HIV-1), subtype A, was studied in three Rwandan mother-child pairs over a period of 12-30 months. In two pairs a homogeneous subtype A V3 sequence population was observed at seroconversion and the virus populations in the children resembled those in the mothers. One of these mother-child pairs was infected with an A/C recombinant virus (Ap17/Cp24). In the third pair, a heterogeneous V3 sequence population was observed in the maternal seroconversion sample but the V3 sequence population in the child's sample was homogeneous. In each individual the intra- and intersample variation (between the seroconversion and follow-up samples) increased over time in both the V3 region and p17gag. Independent evolution for 1-2 years did not abolish the epidemiological relationship between virus populations in mother and child.

To estimate the seroincidence of HIV-1 infection among women of reproductive age in Kigali, Rwanda.Fixed prospective cohort followed for 36 months between November 1988 and June 1992, as part of an ongoing study of mother-to-child transmission of HIV-1.Centre Hospitalier, Kigali, Rwanda.A total of 216 HIV-seronegative women were enrolled at delivery between November 1988 and June 1989.A blood sample was obtained at delivery to test for HIV antibodies (by enzyme-linked immunosorbent assay and Western blot). Serum was tested every 3 months during follow-up. Incidence density rates of HIV seroconversion were estimated.The follow-up rate after 3 years was 89%, assessed by the maximum person-years method. The seroincidence density rate was 3.5 per 100 women-years (95% confidence interval, 1.9-5.0). It decreased linearly from 7.6 during the first 6-months postpartum to 2.5 per 100 women-years during the last 6 months of the third year of follow-up. Maternal age did not affect HIV incidence rates. We examined the role of the cohort, counselling, and the first 6-month postpartum effects on this estimate.This fixed cohort provided an overall estimation of the HIV infection incidence rate and its dynamics. These figures could be used for programming future HIV preventive vaccine efficacy trials in Rwanda.The objective was to estimate the seroincidence of HIV-1 infection among women of reproductive age in Kigali, Rwanda. A fixed prospective cohort followed a total of 216 HIV-seronegative women for 36 months between November 1988 and June 1992 at Centre Hospitalier, Kigali, Rwanda. A study of mother-to-child transmission of HIV-1 has been going on at the Centre Hospitalier de Kigali since November 1988. A group of HIV-seronegative women matched by maternal age and parity was consecutively selected as a comparison group. The mean maternal age was 25.1 years (SD, 4.5 years), and the total number of pregnancies was 2.7 (SD, 1.8). A blood sample was obtained at delivery to test for HIV antibodies (by enzyme-linked immunosorbent assay and Western blot). Serum was tested every 3 months during follow-up. The follow-up rate after 3 years was 89.2% (577/646.75), assessed by the maximum person-years method. 20 seroconversions were documented during the first 36 months of follow-up among the 216 women seronegative at inclusion, yielding a cumulative incidence of 11.2%. The largest number of seroconversions (8/20; 40%) was observed in the first 6 months of the postpartum period. The seroincidence density rate was 3.5/100 women-years (95% confidence interval, 1.9-5.0). It decreased linearly from 7.6 during the first 6-months postpartum to 2.5 per 100 women-years during the last 6 months of the third year of follow-up (P = 0.01). Maternal age did not affect HIV incidence rates. We examined the role of the cohort, counseling, and the first 6-month postpartum effects on this estimate. The study confirms that pregnant women may represent a population in which the HIV seroincidence is high and concentrated in the immediate postpartum period. Pregnant women should become a potential target group for future large scale vaccination trials and programs with adequate follow-up. These figures could be used for programming future HIV preventive vaccine efficacy trials in Rwanda.

Results During the 12 months of follow up, two children died. Seven became resistant and 118 questionnaires were administered. Only two caregivers declared missed takings the previous week, which was contrasting with the counting. The difficulties reported by the caregivers were related to the time slot, and the instruction to take the pills on an empty stomach, the length of the treatment, the ARV's form and palatability. The adherence rate was 98% and 32% of the patients had always had an adherence rate ≥ 95%. The adherence was not correlated to the socio-demographic factors and to the immuno-virological response.