A Study of Decreased Mental Function Associated With HIV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00027040
First received: November 16, 2001
Last updated: October 25, 2012
Last verified: October 2012
  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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 90
Study Completion Date: June 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00027040

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
Sponsors and Collaborators
Investigators
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 April 17, 2014