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NCT00893815 · ClinicalTrials.gov registry record
Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients
A clinical trial, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
- Completed
- Registry status
- 250
- Enrollment target
NCT00893815: Completed study, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
NCT00893815 is a clinical trial that has completed, run by Henry M. Jackson Foundation for the Advancement of Military Medicine. The registered enrollment target is 250 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00893815 has completed, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
- COMPLETED
- Registry status
- 250 participants
- Enrollment target
Study 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.
Primary Outcome
All participants underwent a comprehensive battery of standardized neuropsychological test and questionnaires that have been shown to be sensitive to HIV-associated neurocognitive disorders. Neuropsychological test were scored by trained psychometrists. Raw scores were converted to demographically adjusted t scores corrected for effects of age, education, gender, and ethnicity. Scores were then converted to deficit scores that give differential weight to impair rather than normal scores. The Glo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2009-04 |
| Est. Completion | 2011-09 |
What the finished NCT00893815 record still lists
NCT00893815 is an observational study that tracks outcomes without assigning an intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00893815 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00893815 about?
NCT00893815 is a clinical study titled "Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients". 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 a...
What is the current status of trial NCT00893815?
This trial is currently completed. The enrollment target is 250 participants. The study started on 2009-04. Estimated completion is 2011-09.
Who is sponsoring clinical trial NCT00893815?
This trial is sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine, which has 60 total clinical trials registered on ClinicalTrials.gov.
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