- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00027040
A Study of Decreased Mental Function Associated With HIV
HIV-Associated Cognitive Impairment and Oxidative Stress: An In Vivo Proton Magnetic Resonance Spectroscopy Study of Cerebral Injury
The purpose of this study is to compare pictures of the brain of HIV-infected people with memory problems before and after treatment with selegiline. Selegiline is the study drug received through A5090.
HIV patients generally develop memory problems late in the disease. This will be examined using noninvasive proton magnetic resonance spectroscopy (1H-MRS). The effect of the drug selegiline on memory problems also will be examined.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
HIV-associated cognitive impairment generally develops during the later stages of the disease. This study proposes to non-invasively examine the pattern and extent of cerebral injury associated with HIV infection and its response to selegiline by using 1H-MRS. The following hypotheses will be tested: selegiline, a compound with antioxidant and anti-apoptotic properties, will reverse the metabolic abnormalities measured by 1H-MRS, and these changes will parallel the degree of improvement in cognitive and functional performance.
This is a substudy of ACTG A5090. The pattern and extent of cerebral injury associated with HIV infection and its response to selegiline are examined using a 1H-MRS. 1H-MRS evaluations are performed at screening and Week 24 (or at the time of premature discontinuation) of Step 1 of A5090. The screening MRS exams may only be performed once all A5090 screening evaluations (including the lumbar puncture) have been completed and it has been determined that the patient is eligible for A5090 study entry.
The screening MRS must be performed prior to A5090 study drug administration. The Week-24 MRS must be performed while the patient is still on blinded study drug.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095
- UCLA CARE Ctr
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San Diego, California, United States, 92103
- Univ of California, San Diego
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Stanford, California, United States, 94305-5107
- Stanford University
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hosp
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New York
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New York, New York, United States, 10029
- Mount Sinai Med Ctr
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New York, New York, United States, 10032
- Columbia Presbyterian Med Ctr
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Rochester, New York, United States, 14642
- Univ of Rochester Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Univ of Pennsylvania
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Stanley Street Treatment and Resource
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Providence, Rhode Island, United States, 02906
- Rhode Island Hosp
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Providence, Rhode Island, United States, 02906
- The Miriam Hosp
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Washington
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Seattle, Washington, United States, 98104
- Univ of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Patients may be eligible for this study if they:
- Are enrolled in ACTG protocol A5090.
- Meet the inclusion/exclusion criteria set forth for the Step 1 phase of AACTG protocol A5090.
Exclusion Criteria
Patients will not be eligible for this study if they have:
- Claustrophobia (unless sedation with lorazepam or zolpidem allows for safe performance of the MRS).
- Metallic implants/medical devices (e.g., skull implants or cardiac devices).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Investigators
- Study Chair: Bradford Navia
- Study Chair: Giovanni Schifitto
Publications and helpful links
Study record dates
Study Major Dates
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Neurocognitive Disorders
- Cognition Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Neuroprotective Agents
- Protective Agents
- Psychotropic Drugs
- Antidepressive Agents
- Monoamine Oxidase Inhibitors
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Selegiline
Other Study ID Numbers
- A5114s
- AACTG A5114s
- ACTG A5114s
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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