A Study of Decreased Mental Function Associated With HIV
NCT ID: NCT00027040
Last Updated: 2015-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2005-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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TREATMENT
Interventions
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Selegiline hydrochloride
Eligibility Criteria
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Inclusion Criteria
* Are enrolled in ACTG protocol A5090.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Giovanni Schifitto
Role: STUDY_CHAIR
Bradford Navia
Role: STUDY_CHAIR
Locations
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UCLA CARE Ctr
Los Angeles, California, United States
Univ of California, San Diego
San Diego, California, United States
Stanford University
Stanford, California, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Mount Sinai Med Ctr
New York, New York, United States
Columbia Presbyterian Med Ctr
New York, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, United States
Rhode Island Hosp
Providence, Rhode Island, United States
Stanley Street Treatment and Resource
Providence, Rhode Island, United States
The Miriam Hosp
Providence, Rhode Island, United States
Univ of Washington
Seattle, Washington, United States
Countries
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References
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Schifitto G, Yiannoutsos CT, Ernst T, Navia BA, Nath A, Sacktor N, Anderson C, Marra CM, Clifford DB; ACTG 5114 Team. Selegiline and oxidative stress in HIV-associated cognitive impairment. Neurology. 2009 Dec 8;73(23):1975-81. doi: 10.1212/WNL.0b013e3181c51a48. Epub 2009 Nov 4.
Other Identifiers
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AACTG A5114s
Identifier Type: -
Identifier Source: secondary_id
ACTG A5114s
Identifier Type: -
Identifier Source: secondary_id
A5114s
Identifier Type: -
Identifier Source: org_study_id
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