Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia
Completed · Phase 1
Conditions studied: Cognitive Disorders, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002148
- Run by
- University of Rochester
- People needed
- 30
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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).
Where it is running
- Johns Hopkins Hosp — Baltimore, Maryland, United States
- Columbia Univ — New York, New York, United States
- Univ of Rochester Med Ctr — Rochester, New York, United States
Full record on ClinicalTrials.gov
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