A Study of Decreased Mental Function Associated With HIV

NCT ID: NCT00027040

Last Updated: 2015-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cognitive Disorders HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Selegiline hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients may be eligible for this study if they:

* Are enrolled in ACTG 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giovanni Schifitto

Role: STUDY_CHAIR

Bradford Navia

Role: STUDY_CHAIR

Locations

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UCLA CARE Ctr

Los Angeles, California, United States

Site Status

Univ of California, San Diego

San Diego, California, United States

Site Status

Stanford University

Stanford, California, United States

Site Status

Johns Hopkins Hosp

Baltimore, Maryland, United States

Site Status

Mount Sinai Med Ctr

New York, New York, United States

Site Status

Columbia Presbyterian Med Ctr

New York, New York, United States

Site Status

Univ of Rochester Medical Center

Rochester, New York, United States

Site Status

Univ of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Rhode Island Hosp

Providence, Rhode Island, United States

Site Status

Stanley Street Treatment and Resource

Providence, Rhode Island, United States

Site Status

The Miriam Hosp

Providence, Rhode Island, United States

Site Status

Univ of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Schifitto G, Yiannoutsos CT, Ernst T, Navia BA, Nath A, Sacktor N, Anderson C, Marra CM, Clifford DB; ACTG 5114 Team. Selegiline and oxidative stress in HIV-associated cognitive impairment. Neurology. 2009 Dec 8;73(23):1975-81. doi: 10.1212/WNL.0b013e3181c51a48. Epub 2009 Nov 4.

Reference Type RESULT
PMID: 19890073 (View on PubMed)

Other Identifiers

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AACTG A5114s

Identifier Type: -

Identifier Source: secondary_id

ACTG A5114s

Identifier Type: -

Identifier Source: secondary_id

A5114s

Identifier Type: -

Identifier Source: org_study_id

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