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| Sponsor: | Otsuka America Pharmaceutical |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002337 |
Purpose
To evaluate the safety and tolerability of four doses of oral vesnarinone in patients with advanced HIV disease.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Vesnarinone |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Safety and Tolerability Study of Four Doses of OPC-8212 (Vesnarinone) in Advanced HIV Disease |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded within 30 days prior to study entry:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00002337 History of Changes |
| Other Study ID Numbers: | 234B, 22-93-252 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Acquired Immunodeficiency Syndrome Antiviral Agents vesnarinone |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Vesnarinone Adjuvants, Immunologic |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Cardiotonic Agents Cardiovascular Agents Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protective Agents |