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Trial record 16 of 33 for:    " April 22, 2009":" May 22, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Infectious Diseases Clinical Research Program
University of California, San Diego
Information provided by (Responsible Party):
Dr. Nancy Crum-Cianflone, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier:
NCT00893815
First received: May 4, 2009
Last updated: October 7, 2014
Last verified: October 2014
  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

Resource links provided by NLM:


Further study details as provided by Uniformed Services University of the Health Sciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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).

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893815

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
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
Infectious Diseases Clinical Research Program
University of California, San Diego
Investigators
Principal Investigator: Brian K Agan, MD Infectious Disease Clinical Research Program (IDCRP)
  More Information

No publications provided by Uniformed Services University of the Health Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: October 7, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Uniformed Services University of the Health Sciences:
HIV
Neurocognitive function

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014