Cognitive DisordersPhase 1NCT00002148
Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia
A Phase 1 study testing OPC 14117 in people with Cognitive Disorders and HIV Infections, run by University of Rochester at 3 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Disorders, HIV Infections
- What is being tested?
- OPC 14117
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins Hosp
Baltimore, Maryland, 212876965
Columbia Univ
New York, New York, 10032
Univ of Rochester Med Ctr
Rochester, New York, 14642
About this study
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.
- Conditions
- Cognitive Disorders, HIV Infections
- Being tested
- OPC 14117
- Keywords
- Cognition Disorders, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Free Radical Scavengers, Antioxidants, OPC 14117
- Medical subject headings
- Cognitive Dysfunction, HIV Infections, Cognition Disorders, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPC 14117Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002148
- Sponsor's protocol ID
- 242A
- Other IDs
- 02-D94
- Status last verified
- Mar 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia
- ClinicalTrials.gov ID
- NCT00002148
- Acronym / sponsor ID
- 242A
- Conditions
- Cognitive Disorders, HIV Infections
- Keywords
- Cognition Disorders, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Free Radical Scavengers, Antioxidants, OPC 14117
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University of RochesterUniversity, hospital or other
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients receive OPC-14117 or placebo bid for 12 weeks, followed by 12 weeks of open label therapy.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV seropositivity.
- Cognitive impairment.
- Prior OPC-14117 other than on the current study.
- Antiretroviral therapy if stable for 6 weeks prior to study entry (12 weeks for stavudine).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPC 14117 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 9222182Safety 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OPC 14117 in people with Cognitive Disorders and HIV Infections, run by University of Rochester at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.