Clinical trial NCT00893815: Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients
Official title: Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Memory
Keywords: HIV
Neurocognitive function
Lead sponsor: Uniformed Services University of the Health Sciences
Sponsor class: FED
Collaborators: name: Infectious Diseases Clinical Research Program
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: University of California, San Diego
First posted: 2009-05-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of 50 HIV-negative patients and at least 200 HIV-positive patients who are 18-50 years of age and current participants of "A Retrospective and Prospective Observational Study of the Natural History of HIV Infection in Active Duty U.S. Military Personnel and Department of Defense Beneficiaries"(RV168).

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: within 30 days
Secondary outcomes:
measure: 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.
timeFrame: within 30 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Infectious Disease Clinical Research Program (IDCRP)
name: Brian K Agan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.