Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients
Despite the advent of highly active antiretroviral therapy (HAART), the prevalence of neurocognitive impairment among HIV-infected patients continues to be an important issue. Although severe forms of AIDS-related dementia have diminished, milder forms of cognitive impairment have been noted among approximately 30% of asymptomatic HIV patients. Studies among HIV-infected U.S. military personnel regarding neurocognitive function have largely been limited to the early 1990s, before the advent of HAART. In these studies subtle neurobehavioral changes were noted among asymptomatic HIV-positive military personnel.
This study proposes to determine the prevalence of neurocognitive deficits among HIV-positive military beneficiaries during the era of HAART who are participants of the U.S. Military HIV Natural History Study. The prevalence ascertained in this study will be compared to HIV-negative military beneficiaries who are demographically similar to the HIV positive group. The sample size of the study is to have complete testing on 200 HIV positive and 50 HIV-negative participants; due to the possibility of attrition before study completion, the investigators will enroll up to 300 participants (240 HIV-positive and 60 HIV-negative) to achieve this sample size. The investigators' rates among HIV-positive patients found in this study will also be contextualized in the setting of the prevalence of prior neurocognitive deficits seen in a HIV positive U.S. military population studied in the 1990s, contemporary rates among civilian HIV-infected persons, and normative values in the general HIV-negative population. Compared to other data in the field of neuropsychology, this study is novel in that the HIV population studied is composed largely of HIV patients who have been diagnosed early in their HIV infection; have open, free access to antiretrovirals to begin therapy earlier than most other cohorts; and consists of highly-functioning, educated individuals.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
San Diego, California, Estados Unidos, 92134
- Naval Medical Center San Diego
-
-
Maryland
-
Bethesda, Maryland, Estados Unidos, 20889
- Walter Reed National Military Medical Center
-
-
Texas
-
Fort Sam Houston, Texas, Estados Unidos, 78234
- Brooke Army Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
HIV Positive Group:
Inclusion Criteria:
- HIV-infected patients who are 18-50 years of age
- Current participants in the U.S. Military HIV Natural History Study (RV168)
Exclusion Criteria:
- Current suicidal ideation
- Inability or unwillingness to complete the full or abbreviated neuropsychological battery and other questionnaires
- An acute medical condition that may impact the participant's ability to complete the tests or that may have a significant impact on the test results as deemed by the site research physicians (e.g., pneumonia, influenza); the subject may participate at a later date if the physician deems that the acute medical illness is resolved.
HIV Negative Group:
Inclusion Criteria:
- Between 18 and 50 years of age.
- A military beneficiary
- HIV negative by an ELISA drawn within one year of study enrollment (or willingness to have HIV test performed which has a negative result)
Exclusion Criteria:
- Inability or unwillingness to complete the full or abbreviated neuropsychological battery and other questionnaires
- Presence of current suicidal thoughts
- An acute medical condition that may impact the participant's ability to complete the tests or that may have a significant impact on the test results as deemed by the site research physicians (e.g., pneumonia, influenza); the subject may participate at a later date if the physician deems that the acute medical illness is resolved.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
1
HIV-Positive and Early HIV infection
|
|
2
HIV-Positive and Late HIV-infection
|
|
3
HIV-negative
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
To determine the prevalence of neurocognitive deficits among HIV-positive patients as defined by the global deficit score based on the neuropsychological testing battery and to compare this rate to HIV-negative military personnel.
Periodo de tiempo: within 30 days
|
within 30 days
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
To determine the prevalence of impairment among HIV-positive compared to HIV-negative military beneficiaries in eight major ability areas: Verbal Fluency, Attention/Working Memory, Speeded Information Processing, Visuospatial Functioning, & Learning.
Periodo de tiempo: within 30 days
|
within 30 days
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Brian K Agan, MD, Infectious Disease Clinical Research Program (IDCRP)
Publicaciones y enlaces útiles
Publicaciones Generales
- Moore DJ, Roediger MJ, Eberly LE, Blackstone K, Hale B, Weintrob A, Ganesan A, Agan BK, Letendre SL, Crum-Cianflone NF. Identification of an abbreviated test battery for detection of HIV-associated neurocognitive impairment in an early-managed HIV-infected cohort. PLoS One. 2012;7(11):e47310. doi: 10.1371/journal.pone.0047310. Epub 2012 Nov 8.
- Crum-Cianflone NF, Moore DJ, Letendre S, Poehlman Roediger M, Eberly L, Weintrob A, Ganesan A, Johnson E, Del Rosario R, Agan BK, Hale BR. Low prevalence of neurocognitive impairment in early diagnosed and managed HIV-infected persons. Neurology. 2013 Jan 22;80(4):371-9. doi: 10.1212/WNL.0b013e31827f0776. Epub 2013 Jan 9.
- Crum-Cianflone NF, Roediger MP, Moore DJ, Hale B, Weintrob A, Ganesan A, Eberly LE, Johnson E, Agan BK, Letendre S. Prevalence and factors associated with sleep disturbances among early-treated HIV-infected persons. Clin Infect Dis. 2012 May;54(10):1485-94. doi: 10.1093/cid/cis192. Epub 2012 Mar 19.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Infecciones por VIH
Otros números de identificación del estudio
- IDCRP-016
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Infecciones por VIH
-
Icahn School of Medicine at Mount SinaiIRRASReclutamientoHemorragia Intraventricular (HIV)Estados Unidos
-
Yale UniversityTerminadoPrecocidad | Recién nacidos de muy bajo peso al nacer | Hemorragia Intraventricular (HIV) | Sangrado en el cerebroEstados Unidos
-
China Medical University HospitalDesconocidoDisplasia broncopulmonar | Bebés extremadamente prematuros | TLP grave que las terapias convencionales han fallado | Sin anomalías congénitas graves | no Hiv Severa Ni FPV QuísticaTaiwán