NCT00002008已完成1 期
An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sandoz
- 试验地点
- 4
研究概览
简要总结
To determine the safety, immunogenicity, biological activity, ad pharmacokinetics of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) human granulocyte-macrophage colony-stimulating factor ( GM-CSF ), given by subcutaneous ( SC ) injection to patients with leukopenia in association with HIV infection.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •Serum antibody to HIV with or without evidence of HIV.
- •Antigenemia.
- •Anticipated survival of at least 6 months.
- •Kaposi's sarcoma.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Malignancy other than Kaposi's sarcoma.
- •Excessive diarrhea (more than 5 liquid or non-liquid stools per day).
- •Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection.
- •Primary hematologic or infectious disorders unrelated to AIDS virus infection.
- •Dementia or altered mental status that would prohibit the giving and understanding of informed consent.
- •Patients with the following are excluded:
- •History of malignancy other than Kaposi's sarcoma.
- •Currently hospitalized or hospitalized within 4 weeks for the treatment of opportunistic infection.
- •Prior Medication:
- •Excluded within 3 weeks of study entry:
- •Marrow suppressive medication.
- •Excluded within 4 weeks of study entry:
- •Any investigational drug.
- •Prior Treatment:
- •Excluded within 4 weeks of study entry:
- •Systemic cytotoxic chemotherapy.
- •Irradiation.
- •Risk Behavior:
- •Excluded within 3 months of study entry:
- •Regular, excessive users of alcohol, hallucinogens, or agents which are addicting.
研究者
研究点 (4)
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