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Home > "A" Clinical Trials Conditions > A Study of Decreased Mental Function Associated with HIV A Study of Decreased Mental Function Associated with HIV
A Study of Decreased Mental Function Associated with HIV
For Condition: HIV Infections,Cognitive Disorders
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Placebo Control
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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).
Total Enrollment: 90
Location and Contact Information:
Overall Study Official:
BradfordNavia, Study Chair,
Univ of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Carol Greisberger 716-275-5871
Mount Sinai Med Ctr *Not yet recruiting*
New York City, New York, 10029
United States
Not yet recruiting Eileen Chusid 212-241-0433
Univ of California, San Diego *Recruiting*
San Diego, California, 92103
United States
Recruiting Jill Kunkel 619-543-8080
Univ of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Joseph Quinn 215-349-8092
Stanford University *Recruiting*
Stanford, California, 94305-5107
United States
Recruiting Debbie Slamowitz 650-723-2804
UCLA CARE Ctr *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Susan McCarthy 310-206-8029
Stanley Street Treatment and Resource *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Joan Gormley 401-793-4396
Univ of Washington *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Jeanne Conley 206-731-8877
The Miriam Hosp *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Joan Gormley 401-793-4396
Johns Hopkins Hosp *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting Charles Raines 410-614-4487
Columbia Presbyterian Med Ctr *Recruiting*
New York City, New York, 10032
United States
Recruiting Mykyelle Crawford 212-305-2665
Rhode Island Hosp *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Joan Gormley 401-793-4396
Additional Information:
Study ID Numbers: ACTG A5114s; AACTG A5114s
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027040
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A Study of Decreased Mental Function Associated with HIV
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