Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients

HIV Infections Clinical Trial

Official title:

Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00893815
• Other study ID #: IDCRP-016
• Status: Active, not recruiting
• Start date: April 2009
• Est. completion date: December 2022

Study information

• Verified date: September 2021
• Source: Uniformed Services University of the Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: December 2022
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Memory

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (4)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 — View Citation

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):1485-9 — View Citation

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-infecte — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		within 30 days
Secondary	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.		within 30 days