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A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients With PGL and/or Constitutional Disease

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Qué se está evaluando

Foscarnet sodium

Medicamento
Quiénes están siendo reclutados

HIV Infections

A partir de 13 años
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 1
Intervencional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 3 de noviembre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

To determine the toxicity of low dose foscarnet administered for 4 weeks to HIV infected patients who are asymptomatic, have AIDS, or other HIV associated conditions and a CD4+ lymphocyte count < 500 cells/mm3. To obtain preliminary efficacy data. Although zidovudine (AZT) has been effective in treating some AIDS patients, AZT has toxic effects in many patients and other means of treating HIV-infected persons need to be evaluated. In vitro (test tube) studies have shown that the human herpes viruses are inhibited by foscarnet and that a number of retroviruses, including HIV, are sensitive to it. It is hoped that treatment of HIV-infected individuals with foscarnet during an early phase of HIV infections will reduce the risk of developing AIDS. Although zidovudine (AZT) has been effective in treating some AIDS patients, AZT has toxic effects in many patients and other means of treating HIV-infected persons need to be evaluated. In vitro (test tube) studies have shown that the human herpes viruses are inhibited by foscarnet and that a number of retroviruses, including HIV, are sensitive to it. It is hoped that treatment of HIV-infected individuals with foscarnet during an early phase of HIV infections will reduce the risk of developing AIDS. Patients are divided into three groups: (1) asymptomatic patients with or without persistent generalized lymphadenopathy (PGL) syndrome; (2) patients with AIDS; and (3) patients who have or have had mild to moderate signs or symptoms consistent with HIV infection. Patients are then randomly chosen to receive one of three different foscarnet doses. The drug is given for 4 weeks, by 1-hour infusion administered every 8 hours. In addition, those patients who are clinically stable and have not experienced severe toxicity at the end of the 4 weeks may continue treatment, in the form of a single daily dose of foscarnet to be administered 5 days per week. Blood samples are taken during treatment and at the first, fourth, and eighth week after treatment. If the patient is on maintenance, blood samples are taken weekly. Effective 7-17-89, patients entering the study are assigned to the lowest foscarnet dose. Patients receive daily treatment for 28 days. Patients who are clinically stable without severe toxicity at 4 weeks have the option of maintenance therapy with foscarnet.

Título OficialA Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients With PGL and/or Constitutional Disease 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 3 de noviembre de 2021
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 10 pacientesNúmero 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.

Cómo se asignan los participantes a diferentes grupos/brazos
En este estudio clínico, los participantes se colocan en grupos de forma aleatoria, como si se lanzara una moneda. Esto garantiza que el estudio sea justo e imparcial, lo que hace que los resultados sean más confiables. Al asignar a los participantes al azar, los investigadores pueden comparar mejor los tratamientos sin influencias externas.

Otras formas de asignar participantes
Asignación no aleatoria
: Los participantes se asignan en función de factores específicos, como su condición médica o la decisión de un médico.

Ninguna (ensayo de un solo brazo)
: Si el estudio tiene un solo grupo, todos los participantes reciben el mismo tratamiento y no se necesita asignación.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios
Cualquier sexoSexo biológico de los participantes elegibles para inscribirse.
A partir de 13 añosRango de edades de los participantes que pueden unirse al estudio.
Voluntarios sanos no permitidosIndica si personas sanas, sin la condición que se estudia, pueden participar.
Condiciones
Patología
HIV Infections
Criterios

Inclusion Criteria Concurrent Medication: Allowed: * Aerosolized pentamidine for secondary Pneumocystis carinii pneumonia (PCP) prophylaxis. * Short course therapy with oral acyclovir (ACV) = or \< 7 days. Short course therapy with ketoconazole = or \< 7 days for patients who are not responding to any other therapy. * Flurazepam. * Diphenhydramine. Prior Medication: Allowed: * Systemic therapy, prophylaxis or maintenance for an AIDS-defining opportunistic infection. Patients with any of the following findings may be included: * Asymptomatic HIV patients with or without lymphadenopathy. * Patients with AIDS as defined by the CDC surveillance case definitions. * Patients with past or present mild to moderate signs or symptoms consistent with HIV infection. * p24 antigen in the serum = or \> 60 pg/ml. Exclusion Criteria Co-existing Condition: Patients with the following will be excluded: * Ongoing systemic therapy / prophylaxis / maintenance for an AIDS-defining opportunistic infection. * Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to entry into the study, or with concurrent neoplasms other than KS or basal cell carcinoma of the skin or in situ carcinoma of the cervix. * Cytomegalovirus (CMV) retinitis. * AIDS dementia. Concurrent Medication: Excluded: * Antiretrovirals. * Immunomodulatory agents. * Corticosteroids Other systemic antiviral or antimicrobial agents. * Experimental medications. * Excluded on chronic basis and discouraged for \> 72 hours: * Acetaminophen. * Narcotics. * Aspirin. Concurrent Treatment: Excluded: * Transfusion dependency or requirement of 2 units of blood more than once per month. Patients with the following will be excluded: * Ongoing systemic therapy / prophylaxis / maintenance for an AIDS-defining opportunistic infection. * Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to entry into the study, or with concurrent neoplasms other than KS or basal cell carcinoma of the skin or in situ carcinoma of the cervix. * Cytomegalovirus (CMV) retinitis. * AIDS dementia. Prior Medication: Excluded within 30 days of study entry: * Antiretroviral agents (except ribavirin). * Immunomodulatory agents. * Excluded within 60 days of study entry: * Ribavirin. The last blood transfusion cannot have been given within 2 weeks of entry. Active substance abuse which could impair compliance with the protocol.



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 11 ubicaciones
Suspendido
Los Angeles County - USC Med CtrLos Angeles, United StatesVer ubicación
Suspendido
USC School of Medicine / Norris Cancer HospLos Angeles, United States
Suspendido
Univ of California / San Diego Treatment CtrSan Diego, United States
Suspendido
Univ of MinnesotaMinneapolis, United States

Completado11 Centros de Estudio