NCT00002129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/mm3
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
研究概览
简要总结
To examine the safety and tolerance of three doses of oral vesnarinone in HIV-infected patients with CD4 count > 300 cells/mm3.
详细描述
Twelve patients per dose level receive vesnarinone at 1 of 3 doses for 12 weeks. At least six patients at a given dose level must have completed 2 weeks of treatment before dose is escalated in subsequent patients.
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, mycobacteria, and herpes simplex.
- •Patients must have:
- •Asymptomatic HIV infection.
- •CD4 count > 300 cells/mm
- •No prior AIDS-defining illness or current constitutional symptoms of HIV disease.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Current history of cardiac disease, including patients who exhibit long QT syndrome on EKG screening.
- •Active malignancy other than cutaneous basal cell carcinoma or in situ carcinoma of the cervix.
- •Concurrent Medication:
- •Antiretroviral agents, including ddI, ddC, and AZT.
- •Immunosuppressive agents.
- •Investigational HIV drugs/therapies including vaccines.
- •Interferon.
- •Steroids (other than topical).
- •Hematopoietins.
- •Megestrol acetate.
- •Trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg sulfamethoxazole thrice weekly.
- •Cytotoxic chemotherapy.
- •Concurrent Treatment:
- •Radiation therapy.
- •Patients with the following prior conditions are excluded:
- •Prior history of cardiac disease.
- •History of agranulocytosis or severe (grade 3) drug-induced neutropenia or documented abnormalities in granulocyte number or function.
- •Prior Medication:
- •AZT, ddI, and ddC within 14 days prior to study entry.
- •Prior cytotoxic chemotherapy.
- •Prior Treatment:
- •Radiation therapy (including electron beam irradiation) within 30 days prior to study entry.
- •Active illicit drug abuse.
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's SarcomaSarcoma, KaposiHIV InfectionsNCT00002131Otsuka America Pharmaceutical28
已完成
1 期
A Study of Multiple Doses of Vesnarinone in Advanced HIV DiseaseHIV InfectionsNCT00002337Otsuka America Pharmaceutical56
已完成
不适用
A Long-Term, Follow-On Safety Study of Four Doses of OPC-8212 (Vesnarinone) in HIV-Infected PersonsHIV InfectionsNCT00002130Otsuka America Pharmaceutical
已完成
1 期
A Study of CI-1012 in HIV-Infected PatientsHIV InfectionsNCT00002196Parke-Davis32
Unknown
1 期
Open-label, Phase I/IIa Study of VAC-3S in HIV-1 Patients Who Showed an Immune Response to VAC-3S During IVVAC-3S/P1HIVNCT02390466InnaVirVax15