Evaluación de la Actividad Antirretroviral del Delavirdine Mesilato en Pacientes Positivos a VIH
Este estudio tiene como objetivo evaluar la seguridad y eficacia del Delavirdine Mesilato como tratamiento para el VIH en individuos que son VIH-positivos.
Delavirdine mesylate
+ Zidovudine
+ Didanosine
Infecciones Transmitidas por la Sangre+13
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Tratamiento
Resumen
Data suggest that bisheteroarylpiperazines (BHAPs) such as delavirdine mesylate are potent and safe anti-HIV agents and may have different biological behavior than other currently available non-nucleoside RT inhibitors. Patients are randomized to receive U-90152 at one of three doses (treatment arms I through III) or either AZT or ddI (treatment arm IV). Patients on arm IV who are AZT-naive receive AZT; those who are AZT-experienced receive ddI. Treatment continues for 24 weeks. PER 12/22/94 AMENDMENT: All patients receiving U-90152 have the same starting dose, to attain one of three target trough levels.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 120 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 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
Criterios
Inclusion Criteria Concurrent Medication: Allowed: PCP prophylaxis. Topical antifungal agents, clotrimazole troches, nystatin oral suspension, topical ketoconazole, and oral fluconazole. Acyclovir (<= 1000 mg/day) as maintenance therapy for herpes simplex virus. Recombinant erythropoietin and G-CSF. Antibiotics for bacterial infections, unless specifically excluded. Symptomatic treatment such as antipyretics, analgesics, nonsteroidal anti-inflammatory agents, and antiemetics. Antacids. Patients must have: HIV-1 infection. CD4 count 200 - 500 cells/mm3. Either no prior antiretroviral therapy or discontinued AZT monotherapy 3 or more weeks prior to study entry. NOTE: Half of patients should be antiretroviral naive. Prior Medication: Allowed: Prior AZT. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Malignancy other than minimal Kaposi's sarcoma. Concurrent Medication: Excluded: Rifabutin. Rifampin. Terfenadine. Astemizole. Loratadine. Trifluoperazine. Piperazine citrate. Any acute or chronic therapy for CMV, MAC, toxoplasmosis, or disseminated fungal infection. Non-study antiretroviral therapies, interferons, biologic response modifiers, and HIV vaccines. Systemic corticosteroids for more than 21 consecutive days. Foscarnet. Systemic cytotoxic chemotherapy for a malignancy. Patients with the following prior conditions are excluded: History of pancreatitis (in patients who received prior AZT). History of grade 2 or worse peripheral neuropathy (in patients who received prior AZT). History of hypersensitivity to BHAP compounds (e.g., trifluoperazine - Stelazine, piperazine citrate - Antepar). Prior Medication: Excluded within 30 days prior to study entry: Any investigational medication. Interferon. Interleukin. Rifabutin. Rifampin. Terfenadine. Astemizole. Loratadine. Trifluoperazine. Piperazine citrate. Excluded at any time: Prior ddI, ddC, d4T, or 3TC. Prior foscarnet. Prior BHAP compound or other non-nucleoside RT inhibitor. Active substance abuse interfering with compliance.
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 10 ubicaciones
University of Colorado Hospital CRS
Aurora, United StatesHoward University Hosp., Div. of Infectious Diseases, ACTU
Washington D.C., United StatesUniv. of Miami AIDS CRS
Miami, United States