NCT00002148

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

March 1, 1996

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Cognitive DisordersHIV Infections

Keywords

Cognition DisordersAcquired Immunodeficiency SyndromeAIDS-Related ComplexFree Radical ScavengersAntioxidantsOPC 14117

Interventions

OPC 14117DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Johns Hopkins Hosp

Baltimore, Maryland, 212876965, United States

Location

Columbia Univ

New York, New York, 10032, United States

Location

Univ of Rochester Med Ctr

Rochester, New York, 14642, United States

Location

Related 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. doi: 10.1212/wnl.49.1.142.

    PMID: 9222182BACKGROUND

MeSH Terms

Conditions

Cognitive DysfunctionHIV InfectionsCognition DisordersAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

OPC 14117

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental DisordersBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1996-03

Locations

US(3)