search
Back to results

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

Primary Purpose

Cognitive Disorders, HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
OPC 14117
Sponsored by
University of Rochester
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Disorders focused on measuring Cognition Disorders, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Free Radical Scavengers, Antioxidants, OPC 14117

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Johns Hopkins Hosp
  • Columbia Univ
  • Univ of Rochester Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
University of Rochester
search

1. Study Identification

Unique Protocol Identification Number
NCT00002148
Brief Title
Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia
Official Title
Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
March 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Rochester

4. Oversight

5. 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.
Detailed Description
Patients receive OPC-14117 or placebo bid for 12 weeks, followed by 12 weeks of open label therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Disorders, HIV Infections
Keywords
Cognition Disorders, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Free Radical Scavengers, Antioxidants, OPC 14117

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
Double
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
OPC 14117

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212876965
Country
United States
Facility Name
Columbia Univ
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Univ of Rochester Med Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9222182
Citation
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. doi: 10.1212/wnl.49.1.142.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs