A Study of Decreased Mental Function Associated With HIV
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Purpose
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 | Intervention |
|---|---|
|
Cognitive Disorders HIV Infections |
Drug: Selegiline hydrochloride |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | HIV-Associated Cognitive Impairment and Oxidative Stress: An In Vivo Proton Magnetic Resonance Spectroscopy Study of Cerebral Injury |
| Estimated Enrollment: | 90 |
| Study Completion Date: | June 2005 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, California | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| Univ of California, San Diego | |
| San Diego, California, United States, 92103 | |
| Stanford University | |
| Stanford, California, United States, 94305-5107 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21287 | |
| United States, New York | |
| Columbia Presbyterian Med Ctr | |
| New York, New York, United States, 10032 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, Pennsylvania | |
| Univ of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Rhode Island | |
| The Miriam Hosp | |
| Providence, Rhode Island, United States, 02906 | |
| Rhode Island Hosp | |
| Providence, Rhode Island, United States, 02906 | |
| Stanley Street Treatment and Resource | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Washington | |
| Univ of Washington | |
| Seattle, Washington, United States, 98104 | |
| Study Chair: | Giovanni Schifitto | |
| Study Chair: | Bradford Navia |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00027040 History of Changes |
| Other Study ID Numbers: | A5114s, AACTG A5114s, ACTG A5114s |
| Study First Received: | November 16, 2001 |
| Last Updated: | October 25, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
AIDS Dementia Complex Selegiline Oxidative Stress Cognition |
Neuroprotective Agents Brain Injuries Magnetic Resonance Spectroscopy Protons |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Cognition Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Selegiline Neuroprotective Agents Monoamine Oxidase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Central Nervous System Agents Therapeutic Uses Antiparkinson Agents Anti-Dyskinesia Agents |
ClinicalTrials.gov processed this record on May 16, 2013