Clinical trial NCT00027040: A Study of Decreased Mental Function Associated With HIV
Official title: HIV-Associated Cognitive Impairment and Oxidative Stress: An In Vivo Proton Magnetic Resonance Spectroscopy Study of Cerebral Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Disorders
HIV Infections
Keywords: AIDS Dementia Complex
Selegiline
Oxidative Stress
Cognition
Neuroprotective Agents
Brain Injuries
Magnetic Resonance Spectroscopy
Protons
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-11-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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: 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 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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA CARE Ctr
state: California
city: San Diego
country: United States
facility: Univ of California, San Diego
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
city: New York
country: United States
facility: Mount Sinai Med Ctr
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Med Ctr
state: New York
city: Rochester
country: United States
facility: Univ of Rochester Medical Center
state: New York
city: Philadelphia
country: United States
facility: Univ of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hosp
state: Rhode Island
city: Providence
country: United States
facility: Stanley Street Treatment and Resource
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hosp
state: Rhode Island
city: Seattle
country: United States
facility: Univ of Washington
state: Washington
Study officials:
name: Giovanni Schifitto
role: STUDY_CHAIR
name: Bradford Navia
role: STUDY_CHAIR
References:
citation: 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.