62 research outputs found
Two-dose intrapartum/newborn nevirapine and standard antiretroviral therapy to reduce perinatal HIV transmission: a randomized trial
No full textCONTEXT:
A 2-dose intrapartum/newborn nevirapine regimen reduced perinatal human immunodeficiency virus (HIV) transmission in Ugandan women not receiving antenatal antiretroviral therapy (ART). However, it is unknown whether the addition of the 2-dose nevirapine regimen to standard ART would further reduce perinatal HIV transmission.
OBJECTIVE:
To determine whether a 2-dose nevirapine regimen can decrease perinatal transmission of HIV in nonbreastfeeding women receiving standard ART.
DESIGN AND SETTING:
International, blinded, placebo-controlled, phase 3 trial enrolling women between May 1997 and June 2000 at clinical sites providing care for HIV infection throughout the United States, Europe, Brazil, and the Bahamas.
PARTICIPANTS:
A total of 1270 women received nevirapine (n = 642) or placebo (n = 628). Infants were followed up for 6 months to determine HIV-infection status, which was available for 1248 deliveries.
INTERVENTION:
A 200-mg dose of oral nevirapine to women after onset of labor and a 2-mg/kg dose of oral nevirapine to newborns between 48 and 72 hours after birth.
MAIN OUTCOME MEASURES:
Detection of HIV infection in infants and grade 3 and 4 toxic effects in women and newborns.
RESULTS:
After review by the data and safety monitoring board, the trial was stopped early because the overall transmission rates were significantly lower than assumed for the study design. Antenatal ART included zidovudine alone in 23%; combinations without protease inhibitors in 36%; and combinations with protease inhibitors in 41%. Thirty-four percent of women had elective cesarean delivery. No significant safety concerns were identified for women or infants. Detection of HIV infection occurred in 9 (1.4%; 95% confidence interval [CI], 0.6%-2.7%) of 631 nevirapine group deliveries and 10 (1.6%; 95% CI, 0.8%-2.9%) of 617 placebo group deliveries. The 95% CI for the difference in transmission rate (-0.2) between the 2 study arms ranged from -1.5% in favor of nevirapine to 1.2% in favor of placebo (P =.82, Fisher exact test). The transmission rate was higher in women with lower baseline CD4 cell counts and higher delivery HIV RNA levels, but there was no significant difference between treatment arms in any subgroup.
CONCLUSION:
Risk of perinatal HIV transmission was low and no benefit from additional intrapartum/newborn nevirapine was demonstrated when women received prenatal care and antenatal ART, and elective cesarean section was made availabl
Comparision between therapeutic efficacy of terbinafine and ketoconazole in Tinea versicolor
No full textBackground and Objective: Tinea versicolor is a common fungal infection of the skin caused
by the dimorphic lipophilic yeast Pityrosporum orbicular (Malassezia furfur). Lesions begin as
multiple small, circular macules of various colors. The upper trunk is most commonly affected
due to the side effects of oral treatment and drug resistance, this study was done to compare the
therapeutic efficacy of topical terbinafine versus topical ketoconazole in Tinea versicolor.
Materials and Methods: This Randomized double blind clinical trial study was conducted
between 2008-09. Sixty nine patients with a clinical diagnosis of pityriasis versicolor confirmed
by microscopic potassium hydroxide (KOH) examination were taken for the study. Patients
randomly divided into 2 treatment groups: 35 patients in terbinafine group, treated by terbinafine
1% once daily for 2 weeks and 34 patients in ketoconazole group, treated with ketoconazole 2%
once daily for 2 weeks. Five patients of terbinafine and 4 patients of ketoconazole groups were
excluded due to lack of follow-up. Patients were followed up at monthly intervals for 3 months
and recurrence and cure rate for each subject were recorded. Data was analyzed by SPSS-16,
t student and Chi-Square test.
Results: The mean moderate cure rate obtained one month after treatment was 20% in
terbinafine group versus 3.3% in ketoconazole group, and there was no any significant difference
between two groups. The mean moderate cure rate two month after treatment was 67.7% in
terbinafine group and 60% in ketoconazole group (P<0.05). The mean complete cure rate three
month after treatment was 73.3% in terbinafine group and 10% in ketoconazole group (P<0.05).
The percent of positive KOH examination, three month after treatment was 10% in terbinafine
group and 36.7% in ketoconazole group (P<0.05).
Conclusion: This study showed that terbinafin is more effective than ketoconazole in treatment
of tinea versicolor.
Keywords: Tinea versicolor, Terbinafine, Ketoconazole, Randomized clinical trial
_______________________________________________________________________
* Corresponding Author: Rostami Mogaddam M (MD), E-mail: [email protected]
Received 13 Oct 2010 Revised 14 Apr 2010 Accepted 6 Jun 2010
This paper should be cited as: Rostami Mogaddam M, Didehvar R, Nasimi M. [Comparision between therapeutic efficacy of terbinafine and ketoconazole in
Tinea versicolor]. J Gorgan Uni Med Sci. Winter 2011; 12 (4): 7-11. [Article in Persian
Chronic hepatitis C virus infection: does it really impact health-related quality of life? A study in rural Egypt.
No full textAucune info claire sur le CTA application de 12 mois par défaut conformément à la politique générale de WileyInternational audiencePrevious Western studies showed a consistent and marked reduction in health-related quality of life (HRQOL) in patients chronically infected with hepatitis C virus (HCV). However, these studies were conducted on patients whose knowledge of their serological status may have affected their HRQOL. This HRQOL survey conducted in the Egyptian rural population provides a unique opportunity to clarify this issue among a population whose serological status is unknown. HRQOL was assessed by an Arabic translation of the Short-Form 12, and a visual analog scale of the relative severity of one's health status. HCV chronic infection was defined by positive tests for anti-HCV antibody and HCV-RNA. HRQOL was compared according to HCV chronic infection status in linear mixed models adjusted for potential confounding factors, such as age, sex, education, and health care-related risk factors, and adjusted for interviewer as a random effect. One hundred forty-six Egyptians chronically infected with HCV had similar Short-Form 12 and visual analog scale scores, compared with 1,140 uninfected controls from the same rural community. In individuals chronically infected with HCV, serum aminotransferase levels did not correlate with HRQOL. In conclusion, this study did not find a significant reduction of HRQOL in patients chronically infected with HCV compared with uninfected, contemporaneous controls. This may be explained in part by a lower morbidity amongst patients chronically infected with HCV in rural Egypt and a higher morbidity amongst uninfected controls as compared with those of Western studies, as well as a lack of awareness of hepatitis C serological status
From the Allerød to the mid-Holocene: Palynological evidence from the south basin of the Caspian Sea
No full textThis article has been made available through the Brunel Open Access Publishing Fund. Copyright @ The Authors. This is an open-access article distributed under the terms of the Creative
Commons Attribution-NonCommercial-No Derivative Works License, which permits
non-commercial use, distribution, and reproduction in any medium, provided
the original author and source are credited.Pollen and dinoflagellate cysts have been analysed in a core from the south basin of the Caspian Sea, providing a picture of respectively past vegetation and water salinity for the Late Pleistocene to middle Holocene. A relatively sharp lithological change at 0.86 m depth reflects a shift from detrital silts to carbonates-rich fine silts. From this depth upwards, a Holocene chronology is built based on ten radiocarbon dates on ostracod shells and bulk carbonates. From the vegetation point of view, the Late Pleistocene deserts and steppes were partially replaced in the most sheltered areas by an open woodland with Pinus, Juniperus-Hippophae-Elaeagnus and even Alnus-Quercus-Pterocarya and Fraxinus, related to the Allerød palynozone. This was interrupted by the Younger Dryas palynozone when Artemisia reaches a maximum in a first instance followed by a very dry phase with only a slight return of Pinus and Quercus and the rare presence of Ulmus-Zelkova. From 11.5 to 8.4 cal. ka BP, an open landscape dominated by shrubs such as Ephedra and progressively increasing Quercus appeared. The final spread of diverse evergreen and deciduous trees is delayed and occurs after 8.4 cal. ka BP. It is suggested that this delay is caused by an arid climate in the Early Holocene linked to high insolation and perhaps to a lake effect. The dinocyst assemblages fluctuate between slightly brackish (Pyxidinopsis psilata and Spiniferites cruciformis, 7 psu and lower) and more brackish (Impagidinium caspienense, ∼13 psu). In the Lateglacial (Khvalynian highstand), the assemblages remained dominated by relative low salinity taxa. A late and brief increase of salinity occurred prior to 11.2 cal. ka BP associated with the Mangyshlak lowstand. It is suggested that it was caused by a brief drop in meltwater flow from both the north and the southeast (Uzboy) and a likely evaporation increase. This lowstand occurs quasi at the same time as the end of a longer lowstand in the Black Sea. The freshest waters are then inferred as having occurred between 8.4 and ≤4.4 cal. ka BP, linked to a connection with the Amu Darya and the melting glaciers on the Pamir Mountains. The Caspian Sea is a sensitive environment, easily perturbed by global climatic changes, such as the Allerød and Holocene warming, and the Lateglacial and Younger Dryas cooling, as well as by regional changes in its hydrography, such as shifts in the Eurasian meltwater and the Volga and Amu Darya inflows.Centre National de la Recherche Scientifique, Franc
Symptomatic acute hepatitis C in Egypt: diagnosis, spontaneous viral clearance, and delayed treatment with 12 weeks of pegylated interferon alfa-2a.
No full textBackground and objectivesThe aim of this study was to estimate the proportion of spontaneous viral clearance (SVC) after symptomatic acute hepatitis C and to evaluate the efficacy of 12 weeks of pegylated interferon alfa-2a in patients who did not clear the virus spontaneously.MethodsPatients with symptomatic acute hepatitis C were recruited from two "fever hospitals" in Cairo, Egypt. Patients still viremic three months after the onset of symptoms were considered for treatment with 12 weeks of pegylated interferon alfa-2a (180 microg/week).ResultsBetween May 2002 and February 2006, 2243 adult patients with acute hepatitis were enrolled in the study. The SVC rate among 117 patients with acute hepatitis C was 33.8% (95%CI [25.9%-43.2%]) at three months and 41.5% (95%CI [33.0%-51.2%]) at six months. The sustained virological response (SVR) rate among the 17 patients who started treatment 4-6 months after onset of symptoms was 15/17 = 88.2% (95%CI [63.6%-98.5%]).ConclusionSpontaneous viral clearance was high (41.5% six months after the onset of symptoms) in this population with symptomatic acute hepatitis C. Allowing time for spontaneous clearance should be considered before treatment is initiated for symptomatic acute hepatitis C
Can context justify an ethical double standard for clinical research in developing countries?
No full textBACKGROUND: The design of clinical research deserves special caution so as to safeguard the rights of participating individuals. While the international community has agreed on ethical standards for the design of research, these frameworks still remain open to interpretation, revision and debate. Recently a breach in the consensus of how to apply these ethical standards to research in developing countries has occurred, notably beginning with the 1994 placebo-controlled trials to reduce maternal to child transmission of HIV-1 in Africa, Asia and the Caribbean. The design of these trials sparked intense debate with the inclusion of a placebo-control group despite the existence of a 'gold standard' and trial supporters grounded their justifications of the trial design on the context of scarcity in resource-poor settings. DISCUSSION: These 'contextual' apologetics are arguably an ethical loophole inherent in current bioethical methodology. However, this convenient appropriation of 'contextual' analysis simply fails to acknowledge the underpinnings of feminist ethical analysis upon which it must stand. A more rigorous analysis of the political, social, and economic structures pertaining to the global context of developing countries reveals that the bioethical principles of beneficence and justice fail to be met in this trial design. CONCLUSION: Within this broader, and theoretically necessary, understanding of context, it becomes impossible to justify an ethical double standard for research in developing countries
Universal test and treat and the HIV epidemic in rural South Africa: a phase 4, open-label, community cluster randomised trial
No full textSAS code files, Stata datasets, and R code used in the analysis published in The Lancet HIV on the project, "Universal test and treat and the HIV epidemic in rural South Africa". This project was funded under the 3ie Combination Prevention Programme supported by the Bill and Melinda Gates Foundation.</span
Mother-to-child transmission of HIV infection in the era of highly active antiretroviral therapy
No full textBackground. Very low rates of mother-to-child transmission (MTCT) of human immunodeficiency virus (HIV) are achievable with use of highly active antiretroviral therapy (HAART). We examine risk factors for MTCT in the HAART era and describe infants who were vertically infected, despite exposure to prophylactic MTCT interventions.
Methods. Of the 4525 mother-child pairs in this prospective cohort study, 1983 were enrolled during the period of January 1997 through May 2004. Factors examined included use of antiretroviral therapy during pregnancy, maternal CD4 cell count and HIV RNA level, mode of delivery, and gestational age in logistic regression analysis.
Results. Receipt of antenatal antiretroviral therapy increased from 5% at the start of the HAART era to 92% in 2001 - 2003. The overall MTCT rate in this period was 2.87% ( 95% confidence interval [CI], 2.11% - 3.81%), but it was 0.99% ( 95% CI, 0.32% - 2.30%) during 2001 - 2003. In logistic regression analysis that included 885 mother-child pairs, MTCT risk was associated with high maternal viral load (adjusted odds ratio [AOR], 12.1;)and elective Caesarean section (AOR, 0.33;). Detection of maternal HIV RNA was significantly Pp. 003 Pp. 04 associated with antenatal use of antiretroviral therapy, CD4 cell count, and mode of delivery. Among 560 women with undetectable HIV RNA levels, elective Caesarean section was associated with a 90% reduction in MTCT risk (odds ratio, 0.10; 95% CI, 0.03 - 0.33), compared with vaginal delivery or emergency Caesarean section.
Conclusions. Our results suggest that offering an elective Caesarean section delivery to all HIV-infected women, even in areas where HAART is available, is appropriate clinical management, especially for persons with detectable viral loads. Our results also suggest that previously identified risk factors remain important
Evidence for a dominant major gene conferring predisposition to hepatitis C virus infection in endemic conditions
No full textInternational audienceHepatitis C virus (HCV), infecting 170 million people worldwide, is a major public health problem. In developing countries, unsafe injections and blood transfusions are thought to be the major routes of transmission. However, our previous work in a population from Egypt, endemic for HCV, revealed highly significant familial correlations, strongly suggesting the existence of both familial transmission of the virus and genetic predisposition to HCV infection. We investigated the hypothesis of genetic predisposition by carrying out a segregation analysis of HCV infection in the same population. We used a logistic regression model simultaneously taking into account a major gene effect, familial correlations and relevant risk factors. We analyzed 312 pedigrees (3,703 subjects). Overall HCV seroprevalence was 11.8% and increased with age. The main associated risk factors were previous parenteral treatment for schistosomiasis and blood transfusions. We found strong evidence for a dominant major gene conferring a predisposition to HCV infection. The frequency of the predisposing allele was 0.013, reflecting a strong predisposition to HCV infection in 2.6% of the subjects, particularly those under the age of 20. This study provides evidence for the involvement of host genetic factors in susceptibility/resistance to HCV infection in endemic conditions
Dissection of familial correlations in hepatitis C virus (HCV) seroprevalence suggests intrafamilial viral transmission and genetic predisposition to infection
No full textInternational audienceObjective: Unsafe injections and transfusions used during treatments are considered to be responsible for many cases of transmission of hepatitis C virus (HCV) in developing countries, but cannot account for a substantial proportion of present infections. The aim of the present work was to investigate familial clustering of HCV infection in a population living in a highly endemic area.Design, setting and participants: A large seroepidemiological survey was conducted on 3994 subjects (age range, 2-88 years) from 475 familial clusters in an Egyptian rural area. Epidemiological methods appropriate for the analysis of correlated data were used to estimate risk factors and familial dependences for HCV infection. A phylogenetic analysis was conducted to investigate HCV strain similarities within and among families.Main outcome measures: HCV familial correlations adjusted for known risk factors, similarities between viral strains.Results: Overall HCV seroprevalence was 12.3%, increasing with age. After adjustment for relevant risk factors, highly significant intrafamilial resemblances in HCV seroprevalence were obtained between father-offspring (odds ratio (OR) = 3.4 (95% confidence interval (CI), 1.8 to 6.2)), mother-offspring (OR = 3.8 (95% CI, 2.5 to 5.8)), and sibling-sibling (OR = 9.3 (95% CI, 4.9 to 17.6)), while a weaker dependence between spouses (OR = 2.2 (95% CI, 1.3 to 3.7)) was observed. Phylogenetic analysis showed greater HCV strain similarity between family members than between unrelated subjects, indicating that correlations can be explained, in part, by familial sources of virus transmission. In addition, refined dissection of correlations between first-degree relatives supported the role of host genes predisposing to HCV infection.Conclusions: Current HCV infection in endemic countries has a strong familial component explained, at least partly, by specific modes of intrafamilial viral transmission and by genetic predisposition to infection
- …
