NCT00002130已完成不适用
A Long-Term, Follow-On Safety Study of Four Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Chemoprophylaxis for Pneumocystis carinii, candida, and mycobacteria.
- •Acyclovir for acute treatment of herpes.
排除标准
- •Concurrent Medication:
- •Antiretroviral agents, including ddI, ddC, AZT, and d4T.
- •Immunosuppressive agents.
- •Investigational HIV drugs/therapies including vaccines.
- •Interferon or other immunomodulating agents.
- •Corticosteroids (other than topical).
- •Megestrol acetate.
- •Agents known to cause neutropenia.
- •Ganciclovir.
- •Cytotoxic chemotherapy.
- •Concurrent Treatment:
- •Radiation therapy.
- •Patients with the following prior conditions are excluded:
- •Poor compliance (less than 80 percent of drug taken) on the Phase I protocol (FDA 234A or FDA 234B).
- •Missed more than one clinic visit on the Phase I protocol.
- •Prior Medication:
- •Acyclovir as prophylaxis for herpes within 48 hours prior to study entry.
- •Patients meet the following criteria:
- •Successful completion of short-term therapy with vesnarinone on FDA 234A or FDA 234B.
- •Active illicit drug abuse.
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Study of Multiple Doses of Vesnarinone in Advanced HIV DiseaseHIV InfectionsNCT00002337Otsuka America Pharmaceutical56
已完成
1 期
A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3HIV InfectionsNCT00002129Otsuka America Pharmaceutical36
已完成
4 期
Tenofovir DF (Disoproxil Fumarate) in Combination With Emtricitabine in HIV-1 PatientsHIV InfectionsNCT00106379Gilead Sciences52
已完成
1 期
A Multicenter Study To Determine Foscarnet Dose Response in HIV Infected Patients With PGL and/or Constitutional DiseaseHIV InfectionsNCT00000729National Institute of Allergy and Infectious Diseases (NIAID)10
已完成
2 期
Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative MenHIV InfectionNCT00131677Centers for Disease Control and Prevention400