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Neurovascular Magnetic Resonance Imaging in the Assessment of HIV-Associated Neurocognitive Disorders

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Qué se está recopilando

Colección de datos

Recopilados desde hoy en adelante - Prospectivo
Quiénes están siendo reclutados

Infecciones Transmitidas por la Sangre+17

+ Enfermedades Urogenitales

+ Enfermedades Genitales

De 25 a 61 años
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Cómo está diseñado el estudio

Observacional
Inicio del estudio: septiembre de 2012
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Resumen

Patrocinador PrincipalNational Institutes of Health Clinical Center (CC)
Última actualización: 5 de diciembre de 2019
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 13 de septiembre de 2012

Fecha en la que se inscribió al primer participante.

With combination antiretroviral therapy, HIV/AIDS has been transformed from a progressive, usually fatal infection to a manageable chronic condition. Yet, HIV associated neurocognitive disorders (HAND) pose a significant clinical problem, even among patients with controlled HIV viremia. There is evidence of accelerated vascular aging and other vascular disorders in HIV-infected (HIV+) people, and studies suggest an association between vascular disorders and unfavorable neurocognitive outcomes. Thus, one possible contributing factor to the high rates of HANDs and depression could be vascular dysfunction, similar to vascular depression and vascular dementia that occur in elderly non-HIV+ individuals. One commonly used diagnostic marker of vasculopathy is thickening of the vessel wall. Multiple studies have already established the correlation between vessel wall thickening and vascular disease manifestations. This prospective observational study aims to examine the relationships between neurocognitive and depression outcomes and vessel wall thickness as a marker of vascular disease in HIV+ adults. We will be using neuropsychological testing, brain imaging, blood biomarkers, and state-of-the-art high-resolution MR imaging of the carotid vessel walls. HIV infected patients (n=40) and HIV-negative controls (n=40) will be recruited. Participants who consent to longitudinal follow-up will be followed for two years with clinical evaluations every 6 months and repeat imaging studies at 12 and 24 months. Cross sectional data analysis will compare markers of vascular and neurocognitive disorders between HIV-infected and HIV-negative participants. The longitudinal data analysis will assess and compare the temporal progression of vascular disease (imaging and blood biomarker findings) in relation to changes in neurocognitive and depression scores in both groups.

NCT01692236
Patrocinador PrincipalNational Institutes of Health Clinical Center (CC)
Última actualización: 5 de diciembre de 2019
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 84 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 25 a 61 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Infecciones Transmitidas por la SangreEnfermedades UrogenitalesEnfermedades GenitalesTrastornos MentalesEnfermedades CardiovascularesEnfermedades TransmisiblesTrastorno depresivoSíndromes de Deficiencia InmunológicaEnfermedades del sistema inmunitarioInfeccionesInfecciones por RetroviridaeInfecciones por virus de ARNEnfermedades de Transmisión SexualEnfermedades por virus lentoEnfermedades ViralesEnfermedades de transmisión sexual, viralesInfecciones por VIHSíndrome de Inmunodeficiencia AdquiridaTrastorno Depresivo MayorEnfermedades Vasculares

Criterios

INCLUSION CRITERIA: Inclusion criteria for all participants: Age 25-61 years. Willingness to allow stored samples, human leukocyte antigen (HLA) testing, and future genetic testing. Hemoglobin less than or equal to 9.0 g/dL, HCT less than or equal to 28%, platelets less than or equal to 50,000/microL. English language fluency (required for neuropsychological testing). Additional inclusion criteria for HIV+ participants: Documented HIV infection by standard HIV testing. Prior documentation of HIV- antibody status at the NIH will be accepted in lieu of repeat testing. HIV viral load below the limit of detection on combination antiretroviral therapy for less than or equal to 1 year. Under the care of a primary care physician. Additional inclusion criteria for HIV-negative participants: 1. HIV-antibody negative. EXCLUSION CRITERIA: Exclusion criteria for all participants: Contraindication to MRI scanning, including pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments. Subjects with a condition precluding entry into scanner and acquisition of scans (e.g., morbid obesity, claustrophobia, back pain, motion disorders). Glomerular filtration rate <45 mL/min/1.73 m(2) as estimated using the Modified Diet in Renal Disease equation. Allergy to qadolinium (MRI contrast) Evidence of current or prior central nervous system opportunistic infection(s) and/or space-occupying lesions such as primary CNS lymphoma. Prior history of intrathecal chemotherapy or radiation therapy to the brain. History of or current diagnosis of systemic vasculitis. Active systemic infection or malignancy requiring therapy. Psychiatric condition interfering with ability to participate in study procedures or provide informed consent. Patient or provider report of alcohol or drug abuse ongoing or within 3 months prior to participation. Sickle cell disease (due to known association with vasculopathy). Systolic blood pressure less than or equal to 180 mmHg at screening. Persons infected with hepatitis C virus (HCV) who are being treated or planning to seek treatment for HCV. Women who are lactating, pregnant, or actively seeking to become pregnant. Other known clinical condition or conditions discovered on MRI that, at the discretion of the investigators, precludes serial clinical, neuropsychological, or imaging evaluation. Additional exclusion criteria for HIV+ participants 1. HIV acquired perinatally (due to potential effects of HIV and antiretroviral therapy on neurocognitive and vascular development).

Plan de Estudio

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Objetivos del Estudio

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

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Este estudio tiene una ubicación

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesAbrir National Institutes of Health Clinical Center, 9000 Rockville Pike en Google Maps
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