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

Launched by THE DANA FOUNDATION · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• • 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.