ClinicalTrials.gg
CompletedNCT00002148Updated Jun 24, 2005

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

A Phase 1 interventional study of OPC 14117 in Cognitive Disorders and HIV Infections, sponsored by University of Rochester. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by University of Rochester · Phase 1, Interventional, and Treatment

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Phase
Phase 1
Study type
Interventional
Enrollment
30
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 14 studies in Cognitive Dysfunction by University of Rochester — 1 open to participants now, 2 under way, none of them phase 3. Cognitive Dysfunction · University of Rochester.

Enrollment
8th of 11
30 · median 40
Phase 1
Only one
of the 14
Registered
1st of 14
by date

Among the 14 studies in Cognitive Dysfunction by University of Rochester, this one is the 8th largest by enrollment of the 11 interventional ones that give a count, is the only one in phase 1, and was the 1st registered.

Cognitive Dysfunction

3,876 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

Browse Cognitive Dysfunction studies →

Open to participants now

1 of the 14 studies in Cognitive Dysfunction by University of Rochester is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

Where they have run

Who these studies take

Of the 753 Cognitive Dysfunction studies recruiting now, 364 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 260 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

Read the detailed description

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

03

Conditions studied

  • Cognitive Disorders
  • HIV Infections

Keywords

  • Cognition Disorders
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Free Radical Scavengers
  • Antioxidants
  • OPC 14117
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients must have:

  • 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

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 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 drugs within the past 30 days. Alcoholism within past 6 months (more than 2 drinks daily).
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Masking
Double
Enrollment
30 participants

Interventions

  • DrugOPC 14117
06

Study locations

3 sites
  • Johns Hopkins Hosp
    Baltimore, Maryland 212876965, United States
  • Columbia Univ
    New York, New York 10032, United States
  • Univ of Rochester Med Ctr
    Rochester, New York 14642, United States
07

References and documents

Publications

  • 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. PubMed 9222182 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00002148
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 1996. You cannot join it, but the record below documents what was studied.

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