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

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002148 on ClinicalTrials.gov Archive Site
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Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia
Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia

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.

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

Interventional
Phase 1
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
  • Cognitive Disorders
  • HIV Infections
Drug: OPC 14117
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002148
242A, 02-D94
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University of Rochester
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NIH AIDS Clinical Trials Information Service
March 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP