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Controlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte (CTL) Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic HIV-1 Infection

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Qué se está evaluando

Indinavir sulfate

+ Diphenhydramine hydrochloride
+ Lymphocytes, Activated
Medicamento
Quiénes están siendo reclutados

HIV Infections

A partir de 18 años
Cómo está diseñado el estudio

Estudio de Tratamiento

Intervencional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 14 de diciembre de 2016
Extraido de una base de datos validada por el gobierno.Reclamar como socio

To evaluate the safety of anti-HIV CTL therapy in early stage patients and to verify the safety when combined with antiviral therapy with zidovudine/lamivudine/indinavir and low-dose interleukin-2 (IL-2). To compare the effects on plasma and cell-associated viral load following combination drug therapy with and without antiviral CTL in early-stage patients. To study in detail the immune effects of lowering viral burden with antiviral combination drugs with and without T cell infusion on antiviral CTL activity, viral suppression and proliferation, circulating T cell phenotype, T cell apoptosis, CD4 cell numbers, DTH reaction, and inflammatory cytokine levels. In an HIV-infected person, there is an ongoing struggle between HIV replication and host immune control. In the past decade most therapeutic strategies have targeted the virus. This approach has been frustrated by viral mutation to evade drug sensitivity. Promising drugs have recently been approved and there are encouraging sustained results from combination antiviral chemotherapy. However, even the most potent drug regimens do not seem to be curative, may eventually lead to drug resistance and may not completely restore lost immune function. The addition of immune-based therapy to antiviral drugs may lead to better viral control. In an HIV-infected person, there is an ongoing struggle between HIV replication and host immune control. In the past decade most therapeutic strategies have targeted the virus. This approach has been frustrated by viral mutation to evade drug sensitivity. Promising drugs have recently been approved and there are encouraging sustained results from combination antiviral chemotherapy. However, even the most potent drug regimens do not seem to be curative, may eventually lead to drug resistance and may not completely restore lost immune function. The addition of immune-based therapy to antiviral drugs may lead to better viral control. This study has 2 regimens of 8 patients each. Patients are randomized as to CTL infusion only. Patients are stratified by viral load (less than 10,000 copies/ml vs. greater than or equal to 10,000 copies/ml). All patients receive combination drug therapy with AZT/3TC/indinavir for 9 months at which time patients have the option of continuing their study regimen another year or changing therapy. Patients in the T cell treatment regimen (regimen 2) receive 2 infusions of ex vivo expanded autologous anti-HIV CTL at 3 and 6 months after beginning AZT/3TC/indinavir therapy. The second infusion is administered with low-dose sc IL-2 1 day before and 4 days following T cell infusion.

Título OficialControlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte (CTL) Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic HIV-1 Infection 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 14 de diciembre de 2016
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 16 pacientesNúmero 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.

Cómo se administran los tratamientos a los participantes
Los participantes se dividen en diferentes grupos, y cada uno recibe un tratamiento específico al mismo tiempo. Esto ayuda a los investigadores a comparar la eficacia de los distintos tratamientos entre sí.

Otras formas de asignar tratamientos
Asignación a un solo grupo
: Todos reciben el mismo tratamiento.

Asignación cruzada
: Los participantes cambian de tratamiento durante el estudio.

Asignación factorial
: Los participantes reciben diferentes combinaciones de tratamientos.

Asignación secuencial
: Los participantes reciben tratamientos uno tras otro en un orden específico, posiblemente según su respuesta individual.

Otra asignación
: La asignación de tratamientos no sigue un diseño estándar o predefinido.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios
Cualquier sexoSexo biológico de los participantes elegibles para inscribirse.
A partir de 18 añosRango de edades de los participantes que pueden unirse al estudio.
Voluntarios sanos no permitidosIndica si personas sanas, sin la condición que se estudia, pueden participar.
Condiciones
Patología
HIV Infections
Criterios

Inclusion Criteria Patients must have: * Serologically confirmed HIV-1 infection. * CD4 count \>= 400/mm3. Exclusion Criteria Co-existing Condition: Patients with any of the following conditions or symptoms are excluded: * Symptoms of HIV-1 disease, except lymphadenopathy. * Symptoms of cardiac disease. * Evidence of clinical pulmonary disease. * Significant medical disease. Patients with any of the following prior conditions are excluded: * History of symptoms of HIV-1 disease, except lymphadenopathy. * Participation in another experimental AIDS treatment clinical trial within 4 weeks into entry. * History of significant psychiatric disease. * History of pancreatitis, history of neuropathy or neurotoxic drug therapy. * History of serious allergies requiring either systemic steroid therapy or prior hospitalization. * History of significant arrhythmia, infarction or heart failure. Immunomodulatory therapy such as steroids or cyclosporine, systemic chemotherapy or alpha-interferon. Prior Medication: Exclusion: * Past treatment with any protease inhibitor. * History of neurotoxic drug therapy. Risk Behavior: Excluded * Patients with current substance abuse. * Excessive alcohol intake.



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 una ubicación
Suspendido
The Ctr For Blood Research IncBoston, United StatesVer ubicación

Suspendido1 Centros de Estudio