Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia

HIV Infections Clinical Trial

Official title:

Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002148
• Other study ID #: 242A
• Secondary ID: 02-D94
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To assess the tolerability and safety of OPC-14117. To evaluate effects of OPC-14117 on cognitive function, quality of life, and activities of daily living.

Description:

Patients receive OPC-14117 or placebo bid for 12 weeks, followed by 12 weeks of open label therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Patients must have:

• HIV seropositivity.

• Cognitive impairment.

Prior Medication:

Allowed:

• Prior OPC-14117 other than on the current study.

• Antiretroviral therapy if stable for 6 weeks prior to study entry (12 weeks for stavudine).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Current opportunistic CNS infection (i.e., toxoplasmosis or cryptococcal meningitis).

• Severe pre-morbid psychiatric illness including schizophrenia and major depression that would interfere with protocol compliance.

• CNS neoplasms.

• Any other clinically significant condition or laboratory abnormality that would interfere with ability to participate on study.

• Current participation in other drug studies.

Patients with the following prior conditions are excluded:

• Past history of opportunistic CNS infection (i.e., toxoplasmosis or cryptococcal meningitis).

• 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.

• History of adverse reaction / allergy to OPC-14117.

• Prior participation on this study.

Prior Medication:

Excluded:

• Other investigational drugs within the past 30 days. Alcoholism within past 6 months (more than 2 drinks daily).

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Disorders
• HIV Infections

Intervention

Drug:
• OPC 14117

Locations

Country	Name	City	State
United States	Johns Hopkins Hosp	Baltimore	Maryland
United States	Columbia Univ	New York	New York
United States	Univ of Rochester Med Ctr	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

References & Publications (1)

Safety and tolerability of the antioxidant OPC-14117 in HIV-associated cognitive impairment. The Dana Consortium on the Therapy of HIV Dementia and Related Cognitive Disorders. Neurology. 1997 Jul;49(1):142-6. — View Citation