Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Infectious Diseases Clinical Research Program
University of California, San Diego
Information provided by (Responsible Party):
Dr. Nancy Crum-Cianflone, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier:
NCT00893815
First received: May 4, 2009
Last updated: October 7, 2014
Last verified: October 2014

May 4, 2009
October 7, 2014
April 2009
June 2011   (final data collection date for primary outcome 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. [ Time Frame: within 30 days ] [ Designated as safety issue: No ]
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. [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00893815 on ClinicalTrials.gov Archive Site
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. [ Time Frame: within 30 days ] [ Designated as safety issue: No ]
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. [ Time Frame: 2 days ] [ Designated as safety issue: No ]
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Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients
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.

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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

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).

  • HIV Infections
  • Memory
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  • 1
    HIV-Positive and Early HIV infection
  • 2
    HIV-Positive and Late HIV-infection
  • 3
    HIV-negative
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
December 2014
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00893815
IDCRP-016
Yes
Dr. Nancy Crum-Cianflone, Uniformed Services University of the Health Sciences
Uniformed Services University of the Health Sciences
  • Infectious Diseases Clinical Research Program
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • University of California, San Diego
Principal Investigator: Brian K Agan, MD Infectious Disease Clinical Research Program (IDCRP)
Uniformed Services University of the Health Sciences
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP