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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 2, 1999 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00002130 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | A Long-Term, Follow-On Safety Study of Four Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons |
| Official Title ICMJE | A Long-Term, Follow-On Safety Study of Four Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons |
| Brief Summary | To examine the continued safety and tolerability of four doses of vesnarinone in HIV-infected patients who have completed a short-term study (less than 12 months on continuous treatment) of the drug. |
| Detailed Description | Patients who have completed a limited duration study (less than 12 months of continuous treatment) of vesnarinone on protocols FDA 234A or FDA 234B and who have no current signs or symptoms of AIDS-defining illnesses may roll over to this study and continue receiving their regimen of vesnarinone for 12 months beyond their original participation. |
| Study Phase | |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Open Label, Safety Study |
| Condition ICMJE | HIV Infections |
| Intervention ICMJE | Drug: Vesnarinone |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria Concurrent Medication: Allowed:
Exclusion Criteria Concurrent Medication: Excluded:
Concurrent Treatment: Excluded:
Patients with the following prior conditions are excluded:
Prior Medication: Excluded:
Patients meet the following criteria: Successful completion of short-term therapy with vesnarinone on FDA 234A or FDA 234B. Active illicit drug abuse. |
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00002130 |
| Responsible Party | |
| Study ID Numbers ICMJE | 234C, 22-93-253 |
| Study Sponsor ICMJE | Otsuka America Pharmaceutical |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | April 1996 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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