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| Sponsor: | Uniformed Services University of the Health Sciences |
|---|---|
| Collaborators: |
Infectious Diseases Clinical Research Program National Institute of Allergy and Infectious Diseases (NIAID) University of California, San Diego |
| Information provided by: | Uniformed Services University of the Health Sciences |
| ClinicalTrials.gov Identifier: | NCT00893815 |
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: | Case Control, Cross-Sectional |
| Official Title: | Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients |
| Estimated Enrollment: | 250 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
HIV-Positive and Early HIV infection
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2
HIV-Positive and Late HIV-infection
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3
HIV-negative
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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:
Exclusion Criteria:
HIV Negative Group:
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Nancy Crum-Cianflone, MD, MPH | 619-532-7475 | nancy.crum@med.navy.mil |
| Contact: Braden Hale, MD | 619-532-7475 | braden.hale@med.navy.mil |
| United States, California | |
| Naval Medical Center San Diego | Recruiting |
| San Diego, California, United States, 92134 | |
| Contact: Raechel Tejidor, MPH 619-532-7587 raechel.tejidor@med.navy.mil | |
| United States, District of Columbia | |
| Walter Reed Army Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20307 | |
| Contact: Marilyn Dennis 202-782-8708 marilyn.dennis@amedd.army.mil | |
| United States, Maryland | |
| National Naval Medical Center | Recruiting |
| Bethesda, Maryland, United States, 20889 | |
| Contact: Howard Holsinger 301-295-2984 Howard.Holsinger@med.navy.mil | |
| United States, Texas | |
| Brooke Army Medical Center | Recruiting |
| Ft. Sam Houston, Texas, United States, 78234 | |
| Contact: Judy Wessely 210-916-6015 jwessely@idcrp.org | |
| Principal Investigator: | Nancy Crum-Cianflone, MD, MPH | Infectious Diseases Clinical Research Program |
More Information
| Responsible Party: | Infectious Diseases Clinical Research Program/Henry M. Jackson Foundation ( Nancy Crum-Cianflone ) |
| Study ID Numbers: | IDCRP-016 |
| Study First Received: | May 4, 2009 |
| Last Updated: | November 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00893815 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
HIV Neurocognitive function |
|
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |