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

June 23, 2005 updated by: University of Rochester
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 212876965
        • Johns Hopkins Hosp
    • New York
      • New York, New York, United States, 10032
        • Columbia Univ
      • Rochester, New York, United States, 14642
        • Univ of Rochester Med Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (ESTIMATE)

August 31, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

March 1, 1996

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 242A
  • 02-D94

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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