A Study of Decreased Mental Function Associated With HIV

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00027040

Collaborator

(none)

Enrollment

Locations

7.5

Patients Per Site

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Disorders HIV Infections	Drug: Selegiline hydrochloride	N/A

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 Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

HIV-Associated Cognitive Impairment and Oxidative Stress: An In Vivo Proton Magnetic Resonance Spectroscopy Study of Cerebral Injury

Actual Study Completion Date :

Jun 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA CARE Ctr	Los Angeles	California	United States	90095
2	Univ of California, San Diego	San Diego	California	United States	92103
3	Stanford University	Stanford	California	United States	94305-5107
4	Johns Hopkins Hosp	Baltimore	Maryland	United States	21287
5	Mount Sinai Med Ctr	New York	New York	United States	10029
6	Columbia Presbyterian Med Ctr	New York	New York	United States	10032
7	Univ of Rochester Medical Center	Rochester	New York	United States	14642
8	Univ of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
9	Rhode Island Hosp	Providence	Rhode Island	United States	02906
10	Stanley Street Treatment and Resource	Providence	Rhode Island	United States	02906
11	The Miriam Hosp	Providence	Rhode Island	United States	02906
12	Univ of Washington	Seattle	Washington	United States	98104