Cognitive DisordersNCT00027040
A Study of Decreased Mental Function Associated With HIV
A study testing Selegiline hydrochloride in people with Cognitive Disorders and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Disorders, HIV Infections
- What is being tested?
- Selegiline hydrochloride
- How many people
- 90 participants
- Where
- 12 sitesUnited States
- Study dates
- Start not givento Jun 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Johns Hopkins Hosp
Baltimore, Maryland, 21287
UCLA CARE Ctr
Los Angeles, California, 90095
Mount Sinai Med Ctr
New York, New York, 10029
Columbia Presbyterian Med Ctr
New York, New York, 10032
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
Rhode Island Hosp
Providence, Rhode Island, 02906
Stanley Street Treatment and Resource
Providence, Rhode Island, 02906
The Miriam Hosp
Providence, Rhode Island, 02906
Univ of Rochester Medical Center
Rochester, New York, 14642
Univ of California, San Diego
San Diego, California, 92103
Univ of Washington
Seattle, Washington, 98104
Stanford University
Stanford, California, 94305-5107
About this study
Official title: HIV-Associated Cognitive Impairment and Oxidative Stress: An In Vivo Proton Magnetic Resonance Spectroscopy Study of Cerebral Injury
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.
Read the 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.
- Conditions
- Cognitive Disorders, HIV Infections
- Being tested
- Selegiline hydrochloride
- Keywords
- AIDS Dementia Complex, Selegiline, Oxidative Stress, Cognition, Neuroprotective Agents, Brain Injuries, Magnetic Resonance Spectroscopy, Protons
- Medical subject headings
- Cognitive Dysfunction, HIV Infections, AIDS Dementia Complex, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selegiline hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2001 (estimated)
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DisordersStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Enrolment
- 90 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Giovanni Schifitto, Study chairBradford Navia, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027040
- Sponsor's protocol ID
- A5114s
- Other IDs
- AACTG A5114s, ACTG A5114s
- Status last verified
- Oct 2012
- First submitted
- 16 Nov 2001
- Last updated
- 16 Jan 2015
- Results posted
- No
Publications
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.
PubMed 19890073
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV-Associated Cognitive Impairment and Oxidative Stress: An In Vivo Proton Magnetic Resonance Spectroscopy Study of Cerebral Injury
- ClinicalTrials.gov ID
- NCT00027040
- Acronym / sponsor ID
- A5114s
- Conditions
- Cognitive Disorders, HIV Infections
- Keywords
- AIDS Dementia Complex, Selegiline, Oxidative Stress, Cognition, Neuroprotective Agents, Brain Injuries, Magnetic Resonance Spectroscopy, Protons
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Jun 2005 (actual)
- First posted
- 19 Nov 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Are enrolled in ACTG protocol A5090.
- Meet the inclusion/exclusion criteria set forth for the Step 1 phase of AACTG protocol A5090.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selegiline hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
- Results publication: PubMed 19890073Schifitto 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.
Related trials for Cognitive Disorders
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Active, not recruiting
Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
Dementia, Cognitive Impairment
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
Recruiting
Tdcs And cogNitive traininG cOmbined for AUD (TANGO)
Alcohol Use Disorder, Addiction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Schifitto study chair
Bradford Navia study chair
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selegiline hydrochloride in people with Cognitive Disorders and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00027040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2015.