Overview

This trial is active, not recruiting.

Conditions hiv infections, memory
Sponsor Uniformed Services University of the Health Sciences
Collaborator Infectious Diseases Clinical Research Program
Start date April 2009
End date June 2011
Trial size 250 participants
Trial identifier NCT00893815, IDCRP-016

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional
Arm
HIV-Positive and Early HIV infection
HIV-Positive and Late HIV-infection
HIV-negative

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.
time frame: 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.
time frame: within 30 days

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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.

Additional Information

Official title Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients
Principal investigator Brian K Agan, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Uniformed Services University of the Health Sciences.