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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002148
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1996
  Purpose

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.


Condition Intervention Phase
Cognitive Disorders
HIV Infections
Drug: OPC 14117
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 30
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002148

Locations
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 212876965
United States, New York
Columbia Univ
New York, New York, United States, 10032
Univ of Rochester Med Ctr
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002148     History of Changes
Other Study ID Numbers: 242A, 02-D94
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Cognition Disorders
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Free Radical Scavengers
Antioxidants
OPC 14117

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
AIDS Dementia Complex
Cognition Disorders
Dementia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014