Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients

Status:	Active, not recruiting
Conditions:	Cognitive Studies, HIV / AIDS
Therapuetic Areas:	Immunology / Infectious Diseases, Psychiatry / Psychology
Healthy:	No
Age Range:	18 - 50
Updated:	7/21/2018
Start Date:	April 2009
End Date:	December 2018

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.

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.

We found this trial at

sites

Walter Reed National Military Medical Center

8901 Rockville Pike
Bethesda, Maryland 20889

(301) 295-4000