A Randomized Trial of Immediate Versus Deferred Indinavir in Addition to Background Antiretroviral Therapy in HIV-Infected Patients With CD4+ Cell Counts Between 200 and 500/mm3 and Plasma HIV RNA Levels >= 10,000 Copies/ml
Indinavir sulfate
Infecciones Transmitidas por la Sangre+10
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Tratamiento
Resumen
This study aims to examine two management strategies, immediate versus deferred IDV therapy, for their clinical effects in the context of background antiretroviral (AR) therapy, given according to current clinical practice. There is an urgent need to identify the optimal use of IDV in patient management, since clinical endpoint studies have not been completed in the United States. Since there is little information about the long term durability of clinical effects, and even less information about the timing of the initiation of protease inhibitor therapy, exploring the disease progression and survival impact of immediate versus delayed use of IDV will yield important information to guide clinical decision making for this group of patients. Prior to randomization the patient and clinician will determine whether the background therapy will be zidovudine (ZDV) plus lamivudine (3TC) or other background antiretroviral therapy (OBAT). Patients will then be randomized to IDV or matching placebo. AS PER AMENDMENT 06/27/97: The protocol was closed as of 03/25/97, and all patients have been unblinded to their assigned treatment. Patients still on study medication are eligible for the protocol extension. Patients who were randomized to immediate IDV may continue on therapy for up to an additional 4 months. All study therapy, both for those on immediate or delayed therapy, must be discontinued on 10/24/97.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 1900 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 16 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: Topical and/or antifungal agents, except ketoconazole. Treatment, maintenance, or chemoprophylaxis with approved agents for OIs will be given as clinically indicated. Clinically indicated antibiotics, unless excluded. Systemic corticosteroid use for <21 days for acute problems is permitted as clinically indicated. However, chronic systemic corticosteroid use should be avoided. Recombinant erythropoietin (rEPO) and granulocyte-colony stimulating factor (G-CSF, filgrastim). Didanosine (ddI). Regularly prescribed medications, such as antipyretics, antidepressants, oral contraceptives, megestrol acetate, testosterone, or any other medication. Patients must have: A working diagnosis of HIV infection. A CD4+ count between 200 and 500 cells/mm3. Signed, informed parental consent if patient is less than 18. NOTE: The DAIDS Clinical Science Research Committee (CSRC) has deemed this protocol appropriate for prisoner enrollment. Exclusion Criteria Co-existing Condition: Patients with any of the following conditions or symptoms are excluded: Febrile illness with temperature > 38.5 degrees C (101.3 degrees F) within 3 days prior to study entry. Concurrent Medication: Excluded: Non-nucleoside reverse transcriptase inhibitors. Protease inhibitors except IDV. Rifabutin and rifampin. Ketoconazole. Terfenadine, astemizole, cisapride, triazolam and midazolam. Patients with any of the following prior conditions are excluded: History of prior saquinavir (SQV) therapy for more than 14 days. History of any prior protease inhibitor therapy other than SQV. History of serious opportunistic infection.
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 14 ubicaciones
Community Consortium of San Francisco
San Francisco, United StatesAbrir Community Consortium of San Francisco en Google MapsDenver CPCRA / Denver Public Hlth
Denver, United StatesVeterans Administration Med Ctr / Regional AIDS Program
Washington D.C., United StatesAIDS Research Consortium of Atlanta
Atlanta, United States