A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of the Virologic Effect of Two Different Nucleoside Treatment Strategies (Zidovudine Versus Zidovudine in Combination With Didanosine) for HIV Infection in Subjects With CD4+ Counts >= 550 Cells/mm3
Zidovudine
+ Didanosine
Infecciones Transmitidas por la Sangre+10
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Tratamiento
Resumen
Recent studies have shown that during the asymptomatic phase (clinical latency) of HIV infection, there is an extraordinarily large number of infected CD4+ lymphocytes and macrophages throughout the lymphoid system, both in latent and productive states. These findings support the belief that early intervention therapy with reverse transcriptase inhibitors could prolong the clinical latency period. Patients are randomized to receive AZT alone, AZT plus ddI, or no therapy (placebo) daily for 48 weeks. Patients are followed at weeks 2, 4, and 8, and then every 8 weeks thereafter until week 48.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 105 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 13 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: Antibiotics for bacterial infections as clinically indicated. Recombinant erythropoietin (EPO) and G-CSF as clinically indicated for grade 3 or worse anemia and neutropenia, respectively. Antipyretics. Analgesics. Allergy medications. Oral contraceptives. Nonprescription medications such as vitamins or herbal therapies. Concurrent Treatment: Allowed: Radiation therapy to local lesion only. Acupuncture. Patients must have: HIV seropositivity. CD4 count >= 550 cells/mm3. No ARC or AIDS conditions by CDC criteria. Consent of parent or guardian if less than 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Presence of factors predisposing to pancreatitis such as active alcoholism. Other medical conditions that would interfere with study compliance. Concurrent Medication: Excluded: Other antiretrovirals or systemic immunomodulators. Systemic corticosteroids. Systemic cytotoxic chemotherapy. Intravenous pentamidine. Concurrent Treatment: Excluded: Radiation therapy except to local lesion. Patients with the following prior conditions are excluded: History of chronic diarrhea, defined as more than four loose or watery stools on average daily for the past month. History of grade 2 or worse peripheral neuropathy. History of pancreatitis. Bacterial infection requiring antibiotics within 14 days prior to study entry. Prior Medication: Excluded: Prior HIV therapy with antiretrovirals or systemic immunomodulators. Prior Treatment: Excluded within 2 weeks prior to study entry: Transfusion. Active substance abuse or alcoholism.
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 7 ubicaciones
Univ of Minnesota
Minneapolis, United StatesSt Paul Ramsey Med Ctr
Saint Paul, United StatesUniv of Nebraska Med Ctr
Omaha, United States