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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00002148
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Cognitive Disorders HIV Infections Drug: OPC 14117 Phase 1

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Masking: Double
Primary Purpose: Treatment
Official Title: Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Patients must have:

  • HIV seropositivity.
  • Cognitive impairment.

Prior Medication:


  • 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:


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002148

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

ClinicalTrials.gov Identifier: NCT00002148     History of Changes
Other Study ID Numbers: 242A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 1996

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

Additional relevant MeSH terms:
HIV Infections
Cognition Disorders
AIDS Dementia Complex
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders