A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients With Dementia - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002154 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients With Dementia
Official Title ^ICMJE	Parallel Group, Placebo-Controlled, Tolerability and Safety Study of Thioctic Acid and Deprenyl in HIV Dementia
Brief Summary	The purpose of this study is to see if it is safe and effective to give thioctic acid and deprenyl (selegiline hydrochloride), alone or in combination, to HIV-infected patients who have mild to moderate dementia (a decline in their mental abilities).
Detailed Description	Patients are randomized to receive thioctic acid alone, deprenyl alone, thioctic acid/deprenyl, or placebo alone for 10 weeks, after which all patients may receive active drug on an open-label basis. Patients must have seven clinic visits.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind, Safety Study
Condition ^ICMJE	Cognitive Disorders HIV Infections
Intervention ^ICMJE	Drug: Thioctic acid Drug: Selegiline hydrochloride
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	32
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria Concurrent Medication: Allowed: Antiretrovirals provided dose has been stable for at least 6 weeks prior to study entry. Patients must have: HIV seropositivity. Mild to moderate cognitive impairment (problems with short term memory, concentration, and feeling slowed down). No active opportunistic CNS infection. Ability to give informed consent. Prior Medication: Allowed: Prior antiretrovirals provided dose has been stable for at least the past 6 weeks. Prior thioctic acid or deprenyl. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Severe premorbid psychiatric illness including schizophrenia and major depression that would interfere with study compliance. CNS neoplasms. Any other clinically significant condition or laboratory abnormality that would preclude participation on study. Current participation in other drug studies. Concurrent Medication: Excluded: Chemotherapy for malignancy. Patients with the following prior conditions are excluded: History of chronic neurological disorders such as serious head injury, documented stroke, multiple sclerosis, uncontrolled epilepsy, Tourette's syndrome, and other neurodegenerative processes such as Huntington's disease. Prior participation in this study. History of adverse reaction/allergy to thioctic acid or deprenyl. Prior Medication: Excluded: Other investigational drugs within 30 days prior to study entry.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002154
Responsible Party
Study ID Numbers ^ICMJE	250A, 03-D95
Study Sponsor ^ICMJE	The Dana Foundation
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	March 1996
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP