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An Open Label, Multiple Dose Ranging Trial of AL721 in Patients With Persistent Generalized Lymphadenopathy and Symptomatic HIV Infection

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Qué se está evaluando

Colección de datos

Quiénes están siendo reclutados

Complejo Relacionado con el SIDA+13

+ Enfermedades Transmisibles

+ Enfermedades Urogenitales

De 18 a 60 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 1
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

Although zidovudine (AZT) prolongs life in certain AIDS patients, it is not a cure for AIDS and it also has toxic effects in many patients. Therefore, it is necessary to test other drugs in HIV-infected patients. AL-721 is a mixture of lipids (fats) extracted from egg yolks. Laboratory tests suggest that it might inhibit the infectivity of the HIV. AL-721 has been tried so far in a few patients for short periods of time and has been found to be well tolerated. Patients receive AL-721 twice daily. The first dose is taken on an empty stomach 1 hour before a fat-free breakfast, with specific instructions given on foods that are allowed; the second dose is taken at least 3 hours after the evening meal. No snacks are permitted after the evening meal or after the evening dose of study medication. The study is scheduled to last for 16 weeks of treatment and 4 weeks of follow-up. Throughout the study, frequent blood samples will be taken from an arm vein. The blood samples are studied to evaluate any changes in the patient's immune system, any toxic effects that might be detected in the blood, and any changes in the presence of the HIV in the blood.

Título OficialAn Open Label, Multiple Dose Ranging Trial of AL721 in Patients With Persistent Generalized Lymphadenopathy and Symptomatic HIV Infection
NCT00001012
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 50 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 18 a 60 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

Complejo Relacionado con el SIDAEnfermedades TransmisiblesEnfermedades UrogenitalesSíndrome de Inmunodeficiencia AdquiridaInfecciones Transmitidas por la SangreEnfermedades GenitalesEnfermedades del sistema inmunitarioSíndromes de Deficiencia InmunológicaInfeccionesInfecciones por RetroviridaeInfecciones por virus de ARNEnfermedades de Transmisión SexualEnfermedades por virus lentoEnfermedades ViralesEnfermedades de transmisión sexual, viralesInfecciones por VIH

Criterios

Inclusion Criteria * Persistent generalized lymphadenopathy (PGL) (CDC-Group III), defined as palpable lymphadenopathy (nodes of 1 cm or greater) at two or more noncontiguous extrainguinal sites persisting for \> 3 months in the absence of an illness other than HIV infection to account for the findings. * AIDS related complex (ARC), defined as the presence of at least one of the following findings within 12 months prior to entry and the absence of a concurrent illness or condition other than HIV infection to explain the findings: * Any findings which define CDC-Group IV A. * History of any one of the findings that define CDC-Group IV C2. * Patients with any of the ARC symptoms can also have PGL and be enrolled in the protocol as ARC patients. * A positive antibody to HIV by any federally licensed ELISA test kit within 30 days of entry. Concurrent Medication: Allowed: * Topical or oral antifungal, antiviral, or antibiotic agents to treat oral candidiasis, herpes simplex, herpes zoster, or bacterial infections that develop during the course of the study. Exclusion Criteria * Exclude hemophiliacs. * Active substance abuse. * Alcohol consumption should be kept to a minimum. Co-existing Condition: Patients with the following will be excluded: * Hemophilia. * History or presence of an AIDS-defining opportunistic infection or malignancy. * AIDS related complex (ARC) patients with prior (within the last 12 months) or current history of diarrhea defined as = or \> 3 liquid stools per day persisting for longer than 1 month. * Significant malabsorption: * Greater than 10 percent weight loss within past 3 months with serum carotene \< 75 IU/ml or vitamin A \< 75 IU/ml. * Significant cardiac, liver, renal, or neurologic disorder. * Active ARC-defining secondary infection (oral candidiasis, oral hairy leukoplakia, multidermatomal herpes zoster, recurrent nontyphoidal Salmonella bacteremia or Nocardiosis) undergoing therapy or prophylaxis within 7 days of study entry. * Active tuberculosis under treatment. * Concurrent neoplasm other than basal cell carcinoma of the skin or in situ carcinoma of the cervix. Concurrent Medication: Excluded: * Any medication that will interfere with the assessment of AL-721, including nutritional supplements, vitamins, laxatives, and over-the-counter products containing lecithin. * Chemoprophylaxis for Pneumocystis carinii (PCP), candida, herpes simplex, herpes zoster infections, or bacterial infections. * Intravenous topical or oral antifungal, antiviral, or antibiotic agents to treat oral candidiasis, herpes simplex, herpes zoster, or bacterial infections that develop during the course of the study. * Systemic chemotherapy. Prior Medication: Excluded within 30 days of study entry: * Any investigational drug. * Biologic response modifiers. * Corticosteroids. * Chemotherapeutic agents. * Excluded within 90 days of study entry: * Any antiretroviral agent or AL-721.

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 9 ubicaciones

Suspendido

Los Angeles County - USC Med Ctr

Los Angeles, United StatesAbrir Los Angeles County - USC Med Ctr en Google Maps
Suspendido

Charity Hosp / Tulane Univ Med School

New Orleans, United States
Suspendido

Louisiana State Univ Med Ctr / Tulane Med School

New Orleans, United States
Suspendido

Tulane Univ School of Medicine

New Orleans, United States
Completado9 Centros de Estudio