Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients
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Purpose
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.
| Condition |
|---|
|
HIV Infections Memory |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients |
- 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 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 ]
| Estimated Enrollment: | 250 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | December 2014 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
HIV-Positive and Early HIV infection
|
|
2
HIV-Positive and Late HIV-infection
|
|
3
HIV-negative
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | 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 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.
Contacts and Locations| United States, California | |
| Naval Medical Center San Diego | |
| San Diego, California, United States, 92134 | |
| United States, Maryland | |
| Walter Reed National Military Medical Center | |
| Bethesda, Maryland, United States, 20889 | |
| United States, Texas | |
| Brooke Army Medical Center | |
| Ft. Sam Houston, Texas, United States, 78234 | |
| Principal Investigator: | Brian K Agan, MD | Infectious Disease Clinical Research Program (IDCRP) |
More Information
No publications provided
| Responsible Party: | Dr. Nancy Crum-Cianflone, Research Physician, Uniformed Services University of the Health Sciences |
| ClinicalTrials.gov Identifier: | NCT00893815 History of Changes |
| Other Study ID Numbers: | IDCRP-016 |
| Study First Received: | May 4, 2009 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Uniformed Services University of the Health Sciences:
|
HIV Neurocognitive function |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on March 05, 2013
