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1.
Infect Dis Obstet Gynecol ; 2011: 874820, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-21603233

RESUMO

OBJECTIVE: This prospective study was undertaken to evaluate pregnant women's willingness to undergo HSV type-specific serologic testing and factors affecting willingness in an obstetrics/gynecology ambulatory unit. METHODS: At prenatal Visit 1, pregnant women (n = 303) with no history of HSV-2 were tested for HSV-1/HSV-2 before and after they received counseling on genital and neonatal herpes. RESULTS: In both the Unwilling Subgroup and the group that changed from being willing to being unwilling, the most common reasons for choosing not to be tested were not being at risk for genital herpes, being tested is too personal, and concern about what will be done with the results. Of the 134 participants in the Willing/Tested Subgroup, 27 (20%) were HSV-2 seropositive and 81 (60%) were HSV-1 seropositive. Conclusions. These results support the feasibility of HSV serologic testing and counseling in pregnant women.


Assuntos
Herpes Simples/diagnóstico , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Complicações Infecciosas na Gravidez/diagnóstico , Complicações Infecciosas na Gravidez/psicologia , Cuidado Pré-Natal/psicologia , Adulto , Distribuição de Qui-Quadrado , Aconselhamento , Feminino , Herpes Simples/psicologia , Herpes Simples/virologia , Herpesvirus Humano 1/isolamento & purificação , Herpesvirus Humano 2/isolamento & purificação , Humanos , Programas de Rastreamento/psicologia , Gravidez , Complicações Infecciosas na Gravidez/virologia , Estudos Prospectivos
2.
Infect Dis Obstet Gynecol ; 2009: 105376, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-19680456

RESUMO

OBJECTIVE: Genital herpes (GH) recurrences and viral shedding are more frequent in the first year after initial HSV-2 infection. The objective of this study was to provide the first evaluation of valacyclovir 1 g once daily compared to placebo in reducing viral shedding in subjects newly diagnosed with GH. METHODS: 70 subjects were randomized to receive valacyclovir 1 g daily or placebo in a crossover design for 60 days with a 7-day washout period. A daily swab of the genital/anal-rectal area was self-collected for HSV-2 detection by PCR. Subjects attended the clinic for routine study visits and GH recurrence visits. Treatment differences were assessed using a nonparametric crossover analysis. RESULTS: 52 subjects had at least one PCR measurement in both treatment periods and comprised the primary efficacy population. Valacyclovir significantly reduced HSV-2 shedding during all days compared to placebo (mean 2.9% versus 13.5% of all days (P < .01), a 78% reduction). Valacyclovir significantly reduced subclinical HSV-2 shedding during all days compared to placebo (mean 2.4% versus 11.0% of all days (P < .01), a 78% reduction). However, 79% of subjects had no GH recurrences while receiving valacyclovir compared to 52% of subjects receiving placebo (P < .01). CONCLUSION: In this study, the frequency of total and subclinical HSV-2 shedding was greater than reported in earlier studies involving subjects with a history of symptomatic genital recurrences. Our study is the first to demonstrate a significant reduction in viral shedding with valacyclovir 1 g daily compared to placebo in a population of subjects newly diagnosed with HSV-2 infection.


Assuntos
Aciclovir/análogos & derivados , Antivirais/uso terapêutico , Herpes Genital/tratamento farmacológico , Herpes Genital/virologia , Herpesvirus Humano 2/fisiologia , Valina/análogos & derivados , Eliminação de Partículas Virais/efeitos dos fármacos , Aciclovir/uso terapêutico , Adolescente , Adulto , Estudos Cross-Over , Método Duplo-Cego , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Valaciclovir , Valina/uso terapêutico
3.
HIV Clin Trials ; 10(2): 65-75, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-19487176

RESUMO

OBJECTIVE: We analyzed virologic response and safety data from six recent clinical studies conducted in antiretroviral-naïve subjects treated with ABC/3TC or its components to assess the impact of baseline viral load on efficacy and safety endpoints used in the ACTG5202 protocol. METHODS: Primary endpoints were time to virologic failure (confirmed HIV-1 RNA > or = 1,000 copies/mL at 16-24 weeks or > or = 200 copies/mL at > or = 24 weeks) and time to first grade 3 or 4 adverse event or laboratory abnormality that was at least one grade higher than at baseline. The survival distributions of both endpoints were estimated using the Kaplan-Meier method overall and by baseline viral load (<100,000 vs. 100,000 copies/mL). A weighted mean of the virologic response and 95% confidence intervals (CI) were calculated by inverse-variance weighting for baseline viral load 100,000 copies/mL across studies. RESULTS: For subjects with baseline HIV-1 RNA 100,000 copies/mL, the rate of virologic survival ranged from 87% to 95% by 48 weeks. Few subjects treated with ABC/3TC developed grade 3 or 4 adverse events, laboratory toxicities, or changes in lipid levels. The weighted mean (CI) for the pooled virologic response was 91% (87%-96%). CONCLUSION: Based on the A5202 endpoints, ABC/3TC-containing regimens in this analysis had a high rate of virologic survival and were generally well tolerated in antiretroviral-naïve subjects regardless of baseline viral load. The pooled virologic response for ABC/3TC in our analysis is higher than the A5202 estimate.


Assuntos
Fármacos Anti-HIV/farmacologia , Terapia Antirretroviral de Alta Atividade/normas , Infecções por HIV/tratamento farmacológico , HIV-1/efeitos dos fármacos , Lamivudina/farmacologia , Adolescente , Adulto , Idoso , Fármacos Anti-HIV/normas , Terapia Antirretroviral de Alta Atividade/métodos , Carbamatos/farmacologia , Ensaios Clínicos como Assunto , Didesoxinucleosídeos , Combinação de Medicamentos , Feminino , Furanos , Infecções por HIV/virologia , Humanos , Lamivudina/normas , Lopinavir , Masculino , Pessoa de Meia-Idade , Organofosfatos/farmacologia , Pirimidinonas/farmacologia , RNA Viral/sangue , Ensaios Clínicos Controlados Aleatórios como Assunto , Sulfonamidas/farmacologia , Análise de Sobrevida , Carga Viral , Adulto Jovem
4.
J Infect Dis ; 197(9): 1289-95, 2008 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-18422441

RESUMO

A dosage of 1 g of valacyclovir 3 times per day (TID) for 7 days has already been shown to be superior to an oral dosage of 800 mg acyclovir 5 times per day for 7 days in immunocompetent individuals. The objective of this study was to assess the safety and efficacy of an oral dosage of valacyclovir, 1 g TID versus 2 g TID, for the treatment of herpes zoster in immunocompromised patients > or =18 years of age. The oral dosage schedule of 2 g of valacyclovir TID reaches acyclovir plasma levels similar to those achieved with intravenous acyclovir therapy given to immunocompromised patients (10 mg/kg every 8 h for 7 days). In this double-blind study, 87 immunocompromised patients with clinical evidence of localized herpes zoster were randomized to receive oral valacyclovir therapy for 7 days, either 1 g TID or 2 g TID, within 72 h after onset of zoster rash. Patients were seen and assessed for cutaneous healing, zoster-associated pain (ZAP), and/or zoster-associated abnormal sensations (ZAAS), up to 24 weeks. Participants in both arms of the study demonstrated similar median times to full crusting of the rash (8 days), and both dosages were safe and effective therapies for reduction of ZAP and ZAAS in the immunocompromised patient population.


Assuntos
Aciclovir/análogos & derivados , Aciclovir/uso terapêutico , Antivirais/uso terapêutico , Herpes Zoster/tratamento farmacológico , Herpesvirus Humano 3/imunologia , Valina/análogos & derivados , Aciclovir/administração & dosagem , Administração Oral , Adulto , Idoso , Antivirais/administração & dosagem , Antivirais/efeitos adversos , Método Duplo-Cego , Esquema de Medicação , Feminino , Humanos , Hospedeiro Imunocomprometido , Masculino , Pessoa de Meia-Idade , Segurança , Valaciclovir , Valina/administração & dosagem , Valina/uso terapêutico
5.
Sex Transm Dis ; 35(3): 286-90, 2008 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-18157071

RESUMO

BACKGROUND: A substantial number of HSV-2 seropositive individuals lack a history of clinically recognized genital herpes. These individuals can transmit disease during periods of asymptomatic viral shedding. The frequency of asymptomatic shedding and the efficacy of antiviral therapy in reducing shedding has not been assessed in this population. OBJECTIVE: To compare the effect of valacyclovir 1 g once daily for 60 days versus placebo on asymptomatic viral shedding in immunocompetent, HSV-2 seropositive subjects without a history of symptomatic genital herpes infection. STUDY DESIGN: Seventy-three subjects were randomized to receive valacyclovir 1 g daily or placebo for 60 days each in a 2-way crossover design. A daily swab of the genital area was self-collected for HSV-2 detection by polymerase chain reaction. RESULTS: Fifty-six subjects with at least 1 polymerase chain reaction measurement in both treatment periods comprised the primary efficacy population. Valacyclovir significantly reduced shedding during subclinical days compared to placebo [mean, 1.5% vs. 5.1% of subclinical days (P <0.001), a 71% reduction]. Eighty-four percent of subjects had no shedding while receiving valacyclovir versus 54% of subjects on placebo (P <0.001). Eighty-eight percent of patients receiving valacyclovir had no recognized signs or symptoms versus 77% for placebo (P = 0.033). Valacyclovir was not associated with any safety risk compared with placebo. CONCLUSIONS: In this study, asymptomatic viral shedding occurred in a substantial number of HSV-2 seropositive subjects without a history of genital herpes. Valacyclovir 1 g daily significantly reduced asymptomatic shedding compared with placebo in this population.


Assuntos
Aciclovir/análogos & derivados , Antivirais/uso terapêutico , Herpes Genital/tratamento farmacológico , Herpesvirus Humano 2/efeitos dos fármacos , Valina/análogos & derivados , Aciclovir/administração & dosagem , Aciclovir/farmacologia , Aciclovir/uso terapêutico , Administração Oral , Adulto , Anticorpos Antivirais/sangue , Antivirais/administração & dosagem , Estudos Cross-Over , DNA Viral/análise , Método Duplo-Cego , Esquema de Medicação , Ensaio de Imunoadsorção Enzimática , Feminino , Herpes Genital/sangue , Herpes Genital/virologia , Humanos , Masculino , Reação em Cadeia da Polimerase , Resultado do Tratamento , Estados Unidos , Valaciclovir , Valina/administração & dosagem , Valina/farmacologia , Valina/uso terapêutico , Eliminação de Partículas Virais/efeitos dos fármacos
6.
Pharmacogenomics ; 8(12): 1661-91, 2007 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-18085998

RESUMO

OBJECTIVE: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare severe blistering skin diseases, which are mainly caused by drugs. The two idiosyncratic conditions are distinguished on the basis of the degree of blistering, possibly representing diseases at different ends of the same spectrum. A genetic predisposition has been postulated. METHOD: We have retrospectively identified a heterogeneous group of patients with SJS and TEN (n = 73 cases, 141 matched controls) induced by a number of marketed drugs and evaluated effector candidate genetic predisposition. We have used a multivariate genetic analysis method for the first time to handle the heterogeneity of clinical presentation, drug etiology, ethnicity and gender in these adverse events. RESULTS: Our results show that predisposition varied according to ethnicity. There was a correlation for SJS with HLA-B*44, DRB1*07 and with the MHC ancestral 57.1 haplotype (and its constituents) in subjects who self-reported as Caucasians, which did not differ with gender. The HLA-DRB and -DRQ genetic predisposition to SJS seemed to be distinct from that of TEN, but further work is needed for both conditions to identify the causal variants. No conclusion concerning correlations with different drugs could be made because of small numbers in each drug group. CONCLUSION: This study stresses the importance of accurate clinical phenotyping, exemplifies a novel analysis method to dissect complicated samples and calls for collaborative prospective studies.


Assuntos
Síndrome de Stevens-Johnson/induzido quimicamente , Síndrome de Stevens-Johnson/etiologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Carbamazepina/efeitos adversos , Criança , Feminino , Predisposição Genética para Doença , Antígenos HLA-B/genética , Antígenos HLA-DR/genética , Haplótipos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Síndrome de Stevens-Johnson/genética , População Branca
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