Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients

NCT00893815 | Completed Results DMC

• 3 other identifiers: IDCRP-016Y1-AI-5072P30MH062512
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 3

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.

Conditions

HIV Infections; Memory

Keywords

HIV; Neurocognitive function

Outcome Measures

Primary Outcomes (1)

• 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.

  All participants underwent a comprehensive battery of standardized neuropsychological test and questionnaires that have been shown to be sensitive to HIV-associated neurocognitive disorders. Neuropsychological test were scored by trained psychometrists. Raw scores were converted to demographically adjusted t scores corrected for effects of age, education, gender, and ethnicity. Scores were then converted to deficit scores that give differential weight to impair rather than normal scores. The Global Deficit score was used to summarize neuropsychological test results by quantifying the number and degree of impaired performances. A score of of ≥0.5 has been shown to be a sensitive and specific indicator of global neurocognitive impairment.

  within 30 days

Secondary Outcomes (1)

• The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas.

  within 30 days

Study Arms (3)

1

HIV-Positive and Early HIV infection (\<6 years of HIV infection since diagnosis \[based on DoD standard testing\], no prior AIDS-defining condition, and CD4 nadir \>200 cells/mm3)

2

HIV-Positive and Late HIV-infection (HIV infected, not meeting all 3 criteria)

3

HIV-negative (HIV uninfected based on DoD standard testing)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• HIV-infected patients who are 18-50 years of age
• Current participants in the U.S. Military HIV Natural History Study (RV168)

You may not qualify if:

• 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:
• 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)
• 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.

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Infectious Diseases Clinical Research Program: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• University of California, San Diego: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (3)

• 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.

  PMID: 23144815 RESULT

• 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.

  PMID: 23303852 RESULT

• 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.

  PMID: 22431801 RESULT

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Infectious Diseases Clinical Research Program
• Organization: Henry Jackson Foundation

contactus@idcrp.org

Study Officials

• Brian K Agan, MD

  Infectious Disease Clinical Research Program (IDCRP)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2009
• First Posted: May 6, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: August 28, 2025
• Results First Posted: August 28, 2025

Record last verified: 2025-08

Locations

US (3)