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Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Infection in Patients With the Acquired Immunodeficiency Syndrome: A Randomized Multicenter Study of Foscarnet Versus Vidarabine

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Qué se está evaluando

Colección de datos

Quiénes están siendo reclutados

Enfermedades Transmisibles+17

+ Enfermedades Urogenitales

+ Síndrome de Inmunodeficiencia Adquirida

De 13 a 65 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 3
Intervencional
Ver detalles del protocolo

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Foscarnet is a drug that inhibits viruses and has been shown to be effective against infection with Cytomegalovirus and also against infection with the Herpes simplex virus in several patients with AIDS. Vidarabine has been shown to have activity against the Herpes simplex virus in patients who do not have AIDS, but it has not been studied in patients who do have AIDS. This study compares foscarnet and vidarabine treatments for AIDS patients who have herpes simplex infection that has not responded to therapy with acyclovir in the hope that one of these two drugs will help to stop further progression of the herpes simplex infection and may have fewer side effects. Following evaluation studies, patients receive at least 10 days of intravenous (IV) therapy with acyclovir. During this therapy, patients have two serum concentration levels of acyclovir drawn to make sure there are adequate levels of medication in their blood. If skin lesions do not heal after a total of 10 days of therapy with acyclovir, lesions are swabbed for viral culture to test the susceptibility of the virus to therapy with acyclovir, foscarnet, and vidarabine. If the test confirms that the herpes lesions are resistant to acyclovir, patients may choose to participate in the next phase of the study. Following additional evaluation studies, patients are randomized to one of two groups, each of which receives 10-21 days of IV treatment with one of the two alternative medications, foscarnet or vidarabine. Foscarnet is given by IV infusion every 8 hours, and each infusion lasts 1 hour. Vidarabine is given by IV infusion once a day, and each infusion lasts 12 hours. While receiving therapy with either foscarnet or vidarabine, blood tests are done every 3 days for routine lab tests and once a week to determine foscarnet or vidarabine blood levels. Skin lesions are cultured for herpes virus every 5 days. At the end of 10 days of therapy, improvement is evaluated, and the patients can continue to receive therapy if indicated. There is a provision for cross-over treatment if patients show a poor response.

Título OficialTreatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Infection in Patients With the Acquired Immunodeficiency Syndrome: A Randomized Multicenter Study of Foscarnet Versus Vidarabine
NCT00000985
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 26 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 13 a 65 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades TransmisiblesEnfermedades UrogenitalesSíndrome de Inmunodeficiencia AdquiridaInfecciones Transmitidas por la SangreInfecciones por virus ADNEnfermedades GenitalesHerpes simpleInfecciones por HerpesviridaeEnfermedades del sistema inmunitarioSíndromes de Deficiencia InmunológicaInfeccionesInfecciones por RetroviridaeInfecciones por virus de ARNEnfermedades de Transmisión SexualEnfermedades de la PielEnfermedades Cutáneas InfecciosasEnfermedades por virus lentoEnfermedades ViralesEnfermedades de transmisión sexual, viralesInfecciones por VIH

Criterios

Inclusion Criteria Concurrent Medication: Allowed for phase B: * Aerosolized pentamidine prophylaxis for Pneumocystis carinii pneumonia (PCP). Prior Medication: Allowed for phase A: * Ganciclovir. Patients receiving this drug at the time of study enrollment must discontinue the drug at the time of enrollment and for the duration of the study period. Exclusion Criteria Co-existing Condition: For phase A, patients with pre-existing severe neurologic impairment such as seizure disorder or marked or incapacitating ataxia are excluded. Concurrent Medication: Excluded upon entry into phase B: * Ganciclovir. * Immunomodulators. * Probenecid. * Ciprofloxacin. * Allopurinol. * Zidovudine (AZT). * Antiretrovirals. * Other investigational agents. * Acyclovir for another labeled indication. * Potentially nephrotoxic agents. Patients will be excluded from the study for the following reasons: Phase A: * Previous hypersensitivity reaction to foscarnet or vidarabine. Patients who have a documented history of vidarabine intolerance may be eligible for the foscarnet on the non-randomized arm of the study. Phase B: * Clinical response to therapy with acyclovir in phase A described as "healed" or "good." Prior Medication: Excluded within 14 days of study entry: * Immunomodulators or biologic response modifiers. Phase A: * Excluded within 30 days of study entry: * Foscarnet. Phase B: Excluded within 7 days of study entry into phase B: * Any potentially nephrotoxic agent, except acyclovir. Prior Treatment: Excluded for phase A within 14 days of study entry: * Lymphocyte replacement therapy. Patients must demonstrate the following clinical and laboratory findings: Phase A: * HIV positive by federally licensed ELISA test confirmed by Western blot, p24 serum antigen, or a positive HIV culture; or a prior diagnosis of AIDS as defined by Centers for Disease Control criteria. * Mucocutaneous herpes simplex virus (HSV) infection confirmed by viral culture persisting for a minimum of 2 weeks which is clinically resistant to therapy with acyclovir in the opinion of the patient's physician. Phase B: * Persistent shedding of HSV at the completion of or within 1 week after completion of phase A acyclovir therapy as confirmed by viral culture. Documented in vitro resistance of the virus to acyclovir. * All strains must be referred to the Diagnostic Virology Laboratories at either San Francisco General Hospital or Beth Israel Hospital, Boston, for susceptibility testing. * Two serum acyclovir levels drawn during phase A. Results may be pending at time of entry into phase B. * All eligibility evaluations must be performed within 7 days prior to study entry for phase A or B.

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 4 ubicaciones

Suspendido

Rush Univ. Med. Ctr. ACTG CRS

Chicago, United StatesAbrir Rush Univ. Med. Ctr. ACTG CRS en Google Maps
Suspendido

Beth Israel Deaconess - East Campus A0102 CRS

Boston, United States
Suspendido

Univ. of Rochester ACTG CRS

Rochester, United States
Suspendido

University of Washington AIDS CRS

Seattle, United States
Completado4 Centros de Estudio