NCT00002337已完成1 期
A Phase I Safety and Tolerability Study of Four Doses of OPC-8212 (Vesnarinone) in Advanced HIV Disease
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
研究概览
简要总结
To evaluate the safety and tolerability of four doses of oral vesnarinone in patients with advanced HIV disease.
详细描述
Fourteen patients per dose level receive vesnarinone at 1 of 4 doses for 12 weeks. At least seven patients at a given dose level must have completed 4 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 other opportunistic infections.
- •Acyclovir for up to 14 days for acute herpes outbreaks.
- •Patients must have:
- •Documented HIV infection.
- •CD4 count 50 - 300 cells/mm
- •No active opportunistic infections.
- •No fever, diarrhea, or Herpes zoster.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Clinically significant current cardiac disease, including patients who exhibit long QTC syndrome on EKG screening and who have an abnormal cardiothoracic ratio on chest x-ray at baseline.
- •Active malignancy (other than cutaneous Kaposi's sarcoma or cutaneous basal cell carcinoma or in situ carcinoma of the cervix).
- •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).
- •Hematopoietins.
- •Megestrol acetate.
- •Agents known to cause neutropenia.
- •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 or worse) drug-induced neutropenia or documented abnormalities in granulocyte function.
- •Prior Medication:
- •AZT, ddI, ddC, d4T, or other nucleoside analog antiretroviral therapy within 14 days prior to study entry.
- •Prior cytotoxic chemotherapy.
- •Acyclovir for herpes prophylaxis within 48 hours prior to study entry.
- •Prior Treatment:
- •Excluded within 30 days prior to study entry:
- •Erythropoietin, transfusion, or blood product use.
- •Radiation therapy (including electron beam irradiation). Active use of illicit drugs (specifically cocaine, amyl nitrate, heroin, and other cardioactive agents).
研究者
研究点 (1)
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