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

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University of Rochester

Status and phase

Completed
Phase 1

Conditions

HIV Infections
Cognitive Disorders

Treatments

Drug: OPC 14117

Study type

Interventional

Funder types

Other

Identifiers

NCT00002148
02-D94
242A

Details and patient eligibility

About

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.

Full description

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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