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A Study of Decreased Mental Function Associated With HIV

This study is ongoing, but not recruiting participants.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00027040
  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

MedlinePlus related topics:   AIDS    Head and Brain Injuries    Stress   

ChemIDplus related topics:   Selegiline    Selegiline hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Placebo Control
Official Title:   HIV-Associated Cognitive Impairment and Oxidative Stress: An In Vivo Proton Magnetic Resonance Spectroscopy Study of Cerebral Injury

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

Estimated Enrollment:   90

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
Univ of Rochester Medical Center    
      Rochester, New York, United States, 14642
Mount Sinai Med Ctr    
      New York, New York, United States, 10029
Columbia Presbyterian Med Ctr    
      New York, New York, United States, 10032
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

Haga clic aquí para ver información sobre este ensayo clínico en español.  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   ACTG A5114s, AACTG A5114s
First Received:   November 16, 2001
Last Updated:   August 6, 2008
ClinicalTrials.gov Identifier:   NCT00027040
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

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
AIDS Dementia Complex
Acquired Immunodeficiency Syndrome
Stress
Cognition Disorders
Immunologic Deficiency Syndromes
Virus Diseases
Selegiline
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
HIV Infections
Sexually Transmitted Diseases
Brain Injuries
Dementia
Retroviridae Infections
Delirium

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Antiparkinson Agents
Enzyme Inhibitors
Infection
Neuroprotective Agents
Protective Agents
Pharmacologic Actions
Therapeutic Uses
Lentivirus Infections
Monoamine Oxidase Inhibitors
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 04, 2008




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