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	Treatment or Intervention
Cognitive Disorders HIV Infections	Drug: Selegiline hydrochloride

Further Study Details: 

Expected Total Enrollment:  90

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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).

California
      UCLA CARE Ctr, Los Angeles,  California,  90095,  United States
      Univ of California, San Diego, San Diego,  California,  92103,  United States
      Stanford University, Stanford,  California,  94305-5107,  United States
Maryland
      Johns Hopkins Hosp, Baltimore,  Maryland,  21287,  United States
New York
      Univ of Rochester Medical Center, Rochester,  New York,  14642,  United States
      Mount Sinai Med Ctr, New York,  New York,  10029,  United States
      Columbia Presbyterian Med Ctr, New York,  New York,  10032,  United States
Pennsylvania
      Univ of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States
Rhode Island
      The Miriam Hosp, Providence,  Rhode Island,  02906,  United States
      Rhode Island Hosp, Providence,  Rhode Island,  02906,  United States
      Stanley Street Treatment and Resource, Providence,  Rhode Island,  02906,  United States
Washington
      Univ of Washington, Seattle,  Washington,  98104,  United States

Study chairs or principal investigators

Giovanni Schifitto,  Study Chair
Bradford Navia,  Study Chair

Study ID Numbers:  ACTG A5114s; AACTG A5114s
Record last reviewed:  December 2004
Last Updated:  April 7, 2005
Record first received:  November 16, 2001
ClinicalTrials.gov Identifier:  NCT00027040
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08