NCT00002093已完成3 期
A Randomized Phase III Clinical Trial of Daunoxome Versus Combination Chemotherapy With Adriamycin/Bleomycin/Vincristine (ABV) in the Treatment of HIV-Associated Kaposi's Sarcoma.
Nexstar Pharmaceuticals25 个研究点 分布在 1 个国家开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 25
研究概览
简要总结
To compare the toxicity profiles (severity and time to onset from initiation of therapy) between daunorubicin (liposomal) and combination chemotherapy with doxorubicin/bleomycin/vincristine (ABV), with both regimens administered in combination with antiretroviral therapy. To compare the duration of responses, response rates, and times to response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- •Patients must have:
- •HIV infection.
- •Advanced Kaposi's sarcoma.
- •Prior Medication:
- •Prior intralesional vinblastine.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms and conditions are excluded:
- •Acute intercurrent infection other than genital herpes.
- •Uncompensated cardiovascular, hepatic, renal, or pulmonary disease unrelated to Kaposi's sarcoma.
- •Symptomatic peripheral neuropathy.
- •Any condition that compromises ability to give informed consent or complete the study.
- •Concurrent Medication:
- •Concurrent ganciclovir.
- •Patients with the following prior conditions are excluded:
- •Symptomatic AIDS-defining opportunistic infection within 2 weeks of entry.
- •History of malignancy other than Kaposi's sarcoma, basal cell carcinoma, or carcinoma in situ of the cervix.
- •Prior Medication:
- •Prior systemic chemotherapy.
- •Intralesional therapies within 7 days prior to study entry.
- •Growth factors (G-CSF or GM-CSF), immune modifiers, or investigational agents within 14 days prior to study entry.
- •Interferon preparations (alpha or beta) within 28 days prior to study entry.
- •Prior Treatment:
- •Excluded within 7 days prior to study entry:
- •Radiation.
- •Local therapies (e.g., cryotherapy).
研究者
研究点 (25)
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