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Biomedical subjects

V Leroy

Publications and source records attributed to V Leroy.

At least 37 records · Page 2Linked to original sources
PubMed2001

Maternal plasma viral load, zidovudine and mother-to-child transmission of HIV-1 in Africa: DITRAME ANRS 049a trial.

OBJECTIVE: To study the relationship between maternal plasma RNA levels and mother-to-child transmission (MTCT) of HIV-1 in African breastfed children. DESIGN: Nested case-control study within a randomized trial assessing the efficacy of a short maternal zidovudine (ZDV) regimen to reduce MTCT. METHODS: Eligible women received either 300 mg of ZDV twice a day until labour, 600 mg at the beginning of labour and 300 mg twice a day for 7 days post-partum or a placebo. The diagnosis of paediatric HIV-1 infection was based on PCR tests at days 1--8, 45, 90 and 180 then on serology performed at 3 monthl intervals. Plasma HIV-1 RNA was measured at inclusion and on day 8 after delivery for all women who did transmit HIV to their children (cases) using a Chiron branched DNA assay (sensitivity 50 copies/ml) and compared with women who did not transmit (two per case) matched for phase trial, treatment allocation and site. RESULTS: At inclusion, mean log10 viral load was 4.6 among 55 transmitting mothers and 3.7 among 117 non transmitters (P = 0.0001). Among transmitters, the mean difference in log10 viral load between day 8 post-partum and inclusion was -0.13 in the ZDV group (n = 23) versus 0.27 in the placebo group (n = 32; P = 0.01); among non transmitters it was -0.35 for the ZDV group (n = 47) versus 0.27 in the placebo group (n = 70; P < 10(-4)). In multivariate logistic regression analysis, odds ratios for MTCT were 8.7 (95% confidence interval, 3.7-20.6) for 1 log(10) increase of maternal RNA at inclusion and 4.2 (95% confidence interval, 1.7--10.3) for 1 log(10) increase difference from inclusion to day 8 post-partum. CONCLUSION: High maternal viral load at inclusion strongly predicts MTCT of HIV in Africa. A short ZDV treatment regimen decreases significantly maternal viral load from its pretreatment level.

Africa↗
PubMed2001

Influence of three successive antiviral treatments on viral heterogeneity in nonresponder chronic hepatitis C patients.

The purpose of the present study was to assess the viral diversity of hepatitis C virus (HCV) in six nonresponder patients during three unsuccessful treatments. These patients were treated successively with IFN-alpha2a (IFN-alpha) at a posology of 3.10(6) units (MIU) three times a week, 10 MIU three times a week, and a combination of IFN-alpha (3 MIU) plus ribavirin (1,000 mg/day). However, only two chronically infected patients could be included in the study due to the persistence of HCV RNA during the three successive treatments. The viral diversity was analysed by cloning and sequencing the HVR-1 region. The treatment of the two nonresponder patients was associated with the persistence of a wide diversity in the viral population and with the emergence of new or minor variants. Under the influence of standard doses of IFN-alpha, a rearrangement of the quasispecies present was observed at this time point. No significant change in viral load or in the complexity of the quasispecies was observed. A second treatment with a high dose of IFN-alpha induced a significant decrease in the associated viral load and, in one case, resulted in a radical change of the viral diversity. Administration of a combination of IFN-alpha and ribavirin did not affect the evolution of the variants but was followed by the emergence of various multiple variants. These results reinforce the hypothesis of the presence of preexisting quasispecies best adapted to the host environment, and therefore resistant to any current therapy.

Amino Acid Sequence↗
PubMed2001

Changes in histological lesions and serum fibrogenesis markers in chronic hepatitis C patients non-responders to interferon alpha.

BACKGROUND/AIMS: The aim of this study was to evaluate the changes in histological lesions and serum N-terminal peptide of type III procollagen (PIIINP) and hyaluronate (HA) levels in virologic non-responder patients treated by Interferon alpha (IFNalpha). METHODS: We enrolled 183 patients treated by IFNalpha and 56 controls, all with paired biopsy specimens. Yearly liver fibrosis progression was estimated before and during a follow-up of 1 year. RESULTS: By contrast to sustained responders, non-responders (n = 105) did not achieve improvement of histological scores after therapy. Their yearly fibrosis progression rate was similar before and during follow-up (0.18, 95%CI: 0.16-0.20, vs 0.26 (95%CI: 0.12-0.40) fibrosis units/year, NS), and was not different in controls (0.17, 95%CI: 0.06-0.27). The levels of PIIINP and hyaluronate (HA) remained unchanged during follow-up. Histological improvement was observed for the second biopsy in 25% of non-responders, but also in 23% of controls. This improvement was not correlated with decrease of ALT level, viral load, PIIINP, or HA. CONCLUSIONS: Our results suggest that IFNalpha therapy is unable to decrease PIIINP or HA levels and cannot improve the histological outcome in virologic non-responder patients. The histological improvement observed in a subset of patients may be linked to sample fluctuation or lack of reproducibility of histological scores.

Adult↗
PubMed2001

Dynamics of viral quasispecies during interferon therapy in non responder chronic hepatitis C patients.

BACKGROUND: the reference method to study the HCV complexity was cloning and sequence analysis of a sufficient number of clones. The evolution of the viral complexity in chronic non responder patients during treatment with standard doses of interferon was not very well investigate because this method was expensive and labour intensive when large series of patients were concerned. Meanwhile, with the alternative Single-Strand Conformation Polymorphism (SSCP) method, a rough estimation of the quasispecies present in a given sample could be obtained. OBJECTIVES: the aim of the study was to analyse the evolution of HCV heterogeneity, investigated by SSCP analysis targeted to the HVR-1, in 30 nonresponders chronic hepatitis C patients treated by Interferon-alpha 3MUI. RESULTS: genotype 1 was the main HCV type found in this population (77% of non responder patients). Before treatment, the SSCP assay revealed a high complexity pattern: the median of SSCP band number was 9. During IFN-alpha treatment, SSCP band number didn't change. However a significant decrease of the viral load was observed (P<0.01). Patients with variations in their SSCP patterns after therapy significantly decreased HCV RNA levels (P<0.002). In one third of patients the SSCP profile didn't change at all. CONCLUSIONS: we observed that viral heterogeneity didn't change in non responder chronic hepatitis C patients during IFN-alpha treatment. Nevertheless patients with a low number of pre-treatment quasispecies exhibited an improvement of the response (P<0.02). These phenomena were probably due to a selection of resistant variants present prior onset of therapy.

Adult↗
PubMed2001

Meta-analysis of interferon randomized trials in the treatment of viral hepatitis C in naive patients: 1999 update.

The aim of this study was to update our previous meta-analysis of interferon (IFN) in the treatment of hepatitis C and to analyse new factors, namely, HCV RNA end-point, patients with cirrhosis and patients with normal ALT. We use the Der Simonian and Laird method, with heterogeneity and sensitivity analyses. Seventy-six randomized control trials (RCTs) in naive patients were found but we focused our analysis on 59 RCTs with chronic hepatitis C (26 vs. controls and 33 comparing different regimens) and on seven RCTs in acute hepatitis. Interferon-alpha (IFN-alpha) at 3 MU thrice weekly (TIW) for 12 months exhibited 39% of virological end-of-treatment response (ETR) and 17% of virological sustained response (SR), respectively, vs. 1% and 3% in untreated controls (all P < 0.001). There was a significant dose effect (in favour of 6 vs. 3 MU TIW): the virological SR at 6 months were 35% in the 6 MU group (95% CI: 24-47) and 16% in the 3 MU group (95% CI: 8-27) and were at 12 months 43% in the 6 MU group (95%CI: 31-56) and 25% in the 3 MU group (95% CI: 16-37). There was a significant duration effect (12 vs. 6 months) upon the virological SR rate both at 3 and 6 MU: 3 MU provided 14% of virological SR (95% CI: 11-19) in the 12 months group vs. 7% (95% CI: 5-11) in the 6 months group and 6 MU provided 22% (95% CI: 17-29) and 16% (95% CI: 11-22) virological SR in the 12 and 6 months groups, respectively. Cirrhotic treated patients had 17% of virological SR (95 CI: 9-24%; P < 0.001) vs. 0% in controls and provided a 20% reduction rate (95 CI: -2% to -37%, P=0.03) in hepatocellular carcinoma incidence. In acute hepatitis C, a 3-month treatment with IFN-alpha showed significant efficacy vs. controls upon the virological SR rate (32% vs. 4%, P < 0.001). In conclusion, we confirm the dose and duration effect of IFN in chronic hepatitis C, and the efficacy of IFN-alpha in the treatment of acute hepatitis and in cirrhotic patients.

Acute Disease↗
PubMed2000

Preventing mother-to-child transmission of HIV-1 in Africa in the year 2000.

OBJECTIVES: Various approaches to preventing mother-to-child transmission (MTCT) of HIV have recently been, or are being, evaluated in developing countries, especially in Africa. New findings from these trials are now becoming available, the implications of which, for population-based intervention programmes, need urgent consideration. METHOD: A critical review of 18 randomized trials and other relevant studies from developing and industrialized countries. RESULTS: Most African results relate to trials of antiretroviral agents (ARV). They demonstrate efficacy in reducing transmission in the first 6 months of life with short regimens of zidovudine (ZDV), with or without lamivudine (3TC), and nevirapine (NVP) alone. Preliminary results suggest the long-term efficacy of zidovudine. Antiseptic and nutritional interventions have been shown to reduce maternal and infant mortality and morbidity but not MTCT of HIV. HIV confidential voluntary counselling and testing for pregnant women, a short regimen of peripartum ARV with alternatives to breastfeeding such as early weaning or breast milk substitutes from birth currently represent the best option to reduce MTCTof HIV in Africa. However, the prevention of postnatal transmission requires further research, particularly in view of the consequences of different feeding options and the possibility of post-perinatal exposure prophylaxis of newborns with ARV. Issues relating to the implementation of currently validated strategies are discussed.

Africa↗
PubMed2000

[HIV infection in Africa. Clinical and therapeutical research].

UNLABELLED: A MAJOR HEALTH PROBLEM: Human Immunodeficiency Virus (HIV) infection is a major public health problem in sub-Saharan Africa and the care of HIV-infected patients is limited by the lack of resources. Clinical research can play a major role to assess the benefit of preventive and/or curative measures adapted to the context of these countries. To illustrate advances and gaps in HIV/AIDS clinical research in Africa, we explored three issues relevant to this research: opportunistic infections in adults, mother-to-child transmission of HIV and the ethical questions. EPIDEMIOLOGY: Epidemiological African studies have shown: the omnipresence of tuberculosis, first cause of death among HIV+ patients; the frequency of bacterial infections, first cause of serious morbidity and second cause of death; the high frequency of toxoplasmosis, cryptococcal meningitis, isosporiasis, cryptosporidiasis, and other infectious syndromes of unknown etiology. More research efforts need to be done for improving tuberculosis diagnosis, compliance to treatment (evaluation of Directed Observed Therapy), resistance to treatment and primary chemoprophylaxis which has shown clear short term benefit but median term interest remains to be demonstrated. Chemoprophylaxis of opportunistic infections other than tuberculosis needs also to be evaluated: cotrimoxazole reduces the short term mortality of HIV+ patients with tuberculosis and the early serious morbidity of HIV+ patients without tuberculosis. TRANSMISSION: Mother-to-child transmission of HIV can occur during pregnancy, during delivery and the postnatal period by breastfeeding, a common practice in Africa. The overall risk of vertical transmission is estimated to be 30% but the attributable part of breastfeeding needs to be further explored. Beyond the prevention of sexual transmission of HIV among childbearing women and family planning for HIV+ women, interventions aimed to reduce mother-to-child transmission depend on the availability or not of a proposing and realising an HIV counselling and testing: antiretroviral treatments and/or breastfeeding alternatives which reduce efficaciously transmission require HIV testing, while vaginal disinfection and vitamin supplementation whom efficacy needs to be demonstrated do not. PREVENTION: Prevention of mother-to-child transmission and care of HIV+ adults in the area of opportunistic infections are feasible in Africa with an acceptable cost. This requires first to train and inform health care providers and the populations. Lots of uncertainties in these areas are likely to be alleviated by reinforcing clinical and therapeutic research of good quality including the questions of antiretroviral treatment. Ethical issues raised by the design and conduct of clinical research in Africa need a positive thinking to face the HIV African pandemic.

AIDS-Related Opportunistic Infections↗
PubMed2000

Comparison between acute oral/respiratory and chronic stomatitis/gingivitis isolates of feline calicivirus: pathogenicity, antigenic profile and cross-neutralisation studies.

Feline calicivirus (FCV) is a major oral and respiratory pathogen of cats, able to induce subclinical infection as well as acute disease. It is also characterized by a high degree of antigenic variation. This work sought to address the question of the existence of distinct biotypes of FCV. Eight French, 6 British and 9 American FCV isolates, responsible for acute oral/respiratory disease or chronic gingivitis/stomatitis, were compared for their pathogenicity, antigenic profiles and serological relationships. Antigenic profiles were assessed by an indirect immunofluorescence assay with a large panel of characterized monoclonal antibodies. Cross-neutralisation assays were performed with specific cat antisera collected at 30 days p.i., then analysed by calculation of antigenic bilateral relatedness and dominance. Whatever their pathogenic origin, all the isolates induced an acute upper-respiratory tract infection in oronasally infected SPF kittens. Their antigenic profiles were different and did not correlate with their geographical or pathological origin. Cross-neutralisation studies and calculation of the mean bilateral relatedness allowed us to distinguish chronic original isolates from acute original ones. This study did not confirm the existence of FCV biotypes but showed that the chronic carrier state is related to the emergence of antigenically distant viruses.

Animals↗
PubMed2000

Prevention of mother-to-child transmission of HIV in developing countries: recommendations for practice. The Ghent International Working Group on Mother-To-Child Transmission of HIV.

OBJECTIVES: Different approaches to prevent mother-to-child transmission of HIV are being evaluated in developing countries. The first trials using a short regimen of zidovudine have been successful in Thailand, Côte d'Ivoire and Burkina Faso. International and local strategies are now being considered. The Ghent International Working Group on Mother-to-Child Transmission of HIV developed public health policy options to integrate these interventions into basic and maternal and child health (MCH) services. METHODS: The following tasks were undertaken: a critical review of randomized trials; an international pooled analysis of late postnatal transmission of HIV through breastfeeding; a review of the cost-effectiveness and cost-benefit of antiretroviral prophylaxis; a feasibility assessment of preventive strategies, including a postal survey on HIV voluntary counselling and testing (VCT) of pregnant women; the identification of requirements and research priorities for prenatal, obstetric and paediatric care. These projects provided the background for a three-day workshop in Ghent, Belgium, in November 1997. Conclusions were further refined, based on 1998 research findings. RESULTS: A summary of relevant evidence and ten public health recommendations are reported. VCT for pregnant women, a short regimen of zidovudine together with alternatives to breastfeeding currently represent the best option to reduce vertical transmission in most developing countries. The primary goal of the integrated package supporting these interventions is to alleviate overall maternal and infant morbidity and mortality. CONCLUSION: Prevention of mother-to-child transmission of HIV should now be considered for integration into basic health and MCH services of selected countries, with the involvement of governments and donor agencies.

Anti-HIV Agents↗
PubMed2000

Neurokinin receptor antagonists.

Studies on tachykinin peptides and the corresponding neurokinin receptors (NKr) have increased dramatically recently due to the discovery of selective, orally-active, metabolically stable and sometimes CNS penetrating NKr antagonists. After demonstrating the potential use for NKr antagonists in animal models, some compounds have recently progressed into clinical trials and a few results have been published. NKr antagonists have demonstrated efficacy for the treatment of emesis and depression, while results in other areas have been disappointing. Nonetheless, this area is coming to the exciting time of proof of concept in humans. Demonstration of the involvement of tachykinin peptides in biological functions continues to grow, as do the potential indications for NKr antagonists. More drug candidates are undergoing clinical trials for various conditions and these results could widen the potential use for NKr antagonists.

Animals↗
PubMed2000

Preventing mother-to-child transmission of HIV: practical strategies for developing countries.

The HIV pandemic has greatly affected women of childbearing age in developing countries and, thus, their offspring, through mother-to-child transmission (MTCT) of the virus. Scientific advances, most of them established by randomized clinical trials, have recently led to the development of practical strategies aiming to reduce the public health burden of MTCT of HIV. These advances came first in non-breast-feeding populations, for example, in Thailand and, more recently, in African populations, where breast-feeding remains the predominant mode of infant feeding. This article reviews major accomplishments in this area, outlines practical issues for program implementation, and suggests future research needs. Short-course zidovudine and short-course nevirapine in the peripartum period currently represent 2 valid options to reduce MTCT of HIV in developing countries if appropriate prenatal, obstetrical, and postnatal care is provided and if alternatives to breast-feeding are considered according to the local situation and the mother's individual decision.

Anti-HIV Agents↗
PubMed1999

6-month efficacy, tolerance, and acceptability of a short regimen of oral zidovudine to reduce vertical transmission of HIV in breastfed children in Côte d'Ivoire and Burkina Faso: a double-blind placebo-controlled multicentre trial. DITRAME Study Group. DIminution de la Transmission Mère-Enfant.

BACKGROUND: Zidovudine reduces the rate of vertical transmission of HIV in non-breastfed populations. We assessed the acceptability, tolerance, and 6-month efficacy of a short regimen of oral zidovudine in African populations practising breastfeeding. METHODS: A randomised double-blind placebo-controlled trial was carried out in public clinics of Abidjan, Côte d'Ivoire, and Bobo-Dioulasso, Burkina Faso. Eligible participants were women aged 18 years or older, who had confirmed HIV-1 infection and pregnancy of 36-38 weeks duration, and who gave written informed consent. Exclusion criteria were severe anaemia, neutropenia, abnormal liver function, and sickle-cell disease. Women were randomly assigned zidovudine (n=214; 300 mg twice daily until labour, 600 mg at beginning of labour, and 300 mg twice daily for 7 days post partum) or matching placebo (n=217). The primary outcome was the diagnosis of HIV-1 infection in the infant on the basis of sequential DNA PCR tests at days 1-8, 45, 90, and 180. We compared the probability of infection at a given age in the two groups. Analyses were by intention to treat. FINDINGS: Women were enrolled between September, 1995, and February, 1998, when enrolment to the placebo group was stopped. Analysis was based on 421 women and 400 lifeborn infants. Baseline demographic, clinical, and laboratory characteristics were similar in the two groups. The Kaplan-Meier probability of HIV infection in the infant at 6 months was 18.0% in the zidovudine group (n=192) and 27.5% in the placebo group (n=197; relative efficacy 0.38 [95% CI 0.05-0.60]; p=0.027). Adjustment for centre, period of recruitment, mode of delivery, maternal CD4-cell count, duration of labour, prolonged rupture of membranes, and duration of breastfeeding did not change the treatment effect. The proportions of women taking more than 80% of the planned maximum dose were 75% before delivery, 81% during labour, and 83% post partum, without statistical difference between the groups. No major adverse biological or clinical event was reported in excess among women and children of the zidovudine group. INTERPRETATION: A short course of oral zidovudine given during the peripartum period is well accepted and well tolerated, and provides a 38% reduction in early vertical transmission of HIV-1 infection despite breastfeeding.

Adolescent↗
PubMed1999

Counselling patients with hepatitis C.

Hepatitis C virus (HCV) is usually but not exclusively transmitted by the parenteral route. Some precautions are recommended for infected patients as well as his/her close contacts and family members. The risk of sexual transmission and from household contacts is very low. Use of condoms is only recommended in cases of multiple partners and for those at high risk of transmission. Some personal objects should not be shared, i.e. razors, toothbrushes and nail clippers, but it is not necessary to avoid sharing eating utensils. Sexual partners may be tested for anti-HCV HCV-positive individuals should refrain from donating blood, organs and tissue. Clear and evidenced-based information should be provided to patients as to the means of prevention with special attention to individual risk groups such as IV drug abusers. The risk of HCV transmission after needlestick injury, although low, justifies universal precaution measurements for health-care workers. Nosocomial transmission has been described after medical procedures, especially haemodialysis and endoscopy. Thus, disinfection procedures as well as universal precautions are essential for all health-care workers. It is also important for HCV patients to inform health-care workers beforehand about their HCV status. Perinatal transmission is rare and is usually related to the degree of maternal viral load. Pregnancy is not contra-indicated in HCV. infected individuals and breast-feeding is allowed. Finally, HCV patients with active disease should be advised to refrain from alcohol intake, especially during antiviral therapy. After HCV infection it is necessary to consider not only diagnostic and therapeutic steps but also the risk of transmission in the patient's circle and consequences for the patient.

Counseling↗
PubMed1999

Low birthweight in infants born to African HIV-infected women: relationship with maternal body weight during pregnancy: Pregnancy and HIV Study Group (EGE).

The effect of maternal HIV infection on birthweight was estimated. In the prenatal clinic of the Centre Hospitalier de Kigali, HIV screening was proposed to women with a gestational age (GA) of less than 28 weeks. HIV-infected (HIV+) and uninfected (HIV-) women were recruited, when they consented. At inclusion, socioeconomic, obstetrical data, and body weight were collected, a clinical examination was performed, and tests for sexually transmitted diseases (STDs) and malaria were performed. Two prenatal visits were made, at 28-32 and 32-36 weeks, with clinical data and weight measurement. At delivery, birthweight, body length, and head circumference of the infant were documented. At inclusion and at the second follow-up visit, HIV+ women (N = 177) weighed less than HIV- women (N = 194) (p = 0.004). Mean birthweight in infants born to HIV+ women was 2947 g (SD = 429) and 3104 g (SD = 461) in infants born to HIV- women (p = 0.001). Frequencies of low birthweight (LBW, weight < 2500 g), prematurity (GA < 37 weeks, according to Finnström score at birth), and intrauterine growth retardation (defined by LBW and GA > or = 37 weeks) were higher in infants born to HIV+ women than to HIV- women (p = 0.009, 0.01, and 0.053, respectively). In multivariate logistic regression, the association between maternal HIV infection and LBW disappeared (p = 0.61), while low GA (p = 0.01) and low last prenatal weight (p = 0.01) were independant risk factors of LBW. LBW in infants born to HIV+ women could be partly attributable to impaired maternal weight. These results underline the need for nutritional surveillance and dietary counselling, hoping to improve the prognosis of pregnancy in HIV+ women, regardless of other therapeutic interventions.

Adult↗
PubMed1999

Cervical dysplasia and HIV type 1 infection in African pregnant women: a cross sectional study, Kigali, Rwanda. The Pregnancy and HIV Study Group (EGE).

OBJECTIVE: To study the prevalence of cervical squamous intraepithelial lesions (SILs) and their association with HIV-1 infection and immunodeficiency among pregnant women in Kigali, Rwanda. METHODS: As part of a cohort study on the impact of HIV-1 infection on pregnancy outcome, HIV-1 seropositive (HIV+) and seronegative (HIV-) pregnant women were enrolled during the last trimester of pregnancy at the maternity ward of the Centre Hospitalier de Kigali from July 1992 to August 1993. At inclusion, women were screened for sexually transmitted diseases (STDs)--syphilis, Neisseria gonorrhoeae, chlamydia trachomatis, Trichomonas vaginalis. CD4+ lymphocyte counts were measured and a Papanicolaou smear performed. RESULTS: Papanicolaou smear was interpretable in 103 HIV+ women and 107 HIV- women. Prevalence of SILs was significantly higher in HIV+ women than in HIV- women: 24.3% v 6.5% (odds ratio = 4.6; 95% CI: 1.8-12.3). SIL+ women (n = 32) tended to have more STDs than SIL- women (n = 178), but this did not reach a statistical difference: 37.5% and 24.7% respectively (p = 0.13). They also had a mean CD4 count significantly lower than SIL- women (623 and 784 CD4+ cells x 10(6)/l, respectively; p = 0.02). CONCLUSION: SILs were HIV related and the association with immunosuppression was statistically significant. Prevalence of SILs was high in this population of pregnant women with high HIV/STDs prevalence. Screening policy for STDs and SILs in African women should be assessed in prenatal care.

AIDS-Related Opportunistic Infections↗
PubMed1999

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.

Administration, Intravaginal↗