Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals
Colección de datos
Enfermedades Transmisibles+21
+ Enfermedades Urogenitales
+ Infecciones Transmitidas por la Sangre
Estudio de Tratamiento
Resumen
The mechanism by which immune stimulation increases circulating levels of HIV-1 is not known. In particular, it is uncertain whether the transient increase in plasma HIV-1 RNA is due to enhanced replication of an actively replicating pool of HIV-1, or is due instead to activation of proviral sequences in previously resting CD4+ cells. One approach to discriminate these alternatives is a "molecular pulse-chase" experiment. In this approach, drug resistant mutants would be selected by administration of Lamivudine (3TC). Twenty subjects without prior 3TC experience will be treated with 3TC for 2 weeks. On day 14, half of the subjects will receive immunization with both the influenza and pneumococcal vaccine. 3TC will be discontinued at this time. Patients will be followed for 4 weeks after the immunization.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.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: * Antiretroviral therapy, provided the patient has been on the same dose and drugs for 60 days prior to study entry. Patients must have: * Documented HIV infection. * CD4 lymphocyte count of \> 300 cells/mm3. * One plasma HIV-1 RNA level between \>= 20,000 and \< 120,000 copies/ml. Prior Medication: Allowed: * Stable antiretroviral therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: * Presence of an AIDS defining opportunistic infection, including Kaposi's sarcoma. * Allergy to influenza or pneumococcal vaccine or their components; to egg or egg products. * Unexplained temperature \>= 38.5 degrees C for 7 consecutive days within the 30 days prior to study entry. * Concurrent participation in other experimental therapies. Concurrent Medication: Excluded: * Systemic chemotherapy. * Steroids. * Corticosteroids. * Vaccinations. * Any new antiretroviral agents that the patient was not taking at the time of study entry and not prescribed by the study. * Colony stimulating factors including G-CSF or rEPO. * Immune modulators/immune based therapies. Concurrent Treatment: Excluded: * Radiation therapy. * Transfusion dependent patients. Patients with any of the following prior conditions are excluded: * History of an AIDS defining opportunistic infection, including Kaposi's sarcoma (except limited cutaneous diseases \[\< 5 lesions\]). * History of acute or chronic pancreatitis. Prior Medication: Excluded: * Prior treatment with 3TC. Excluded within 30 days of study entry: * Treatment with immune modulators. * Acute or chronic therapy for recognized infections (eg, influenza, HSV, VZV). Excluded within 1 year of study entry: Treatment with an influenza and/or pneumonia vaccine \[AS PER AMENDMENT 1/23/97: * influenza vaccine only\]. \[AS PER AMENDMENT 1/23/97: * Excluded within 3 years of study entry: * Pneumonia vaccine.\]