NCT00002009已完成1 期
A Phase I/II Study of 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 maximum tolerated dose (MTD) and toxicity of sargramostim (recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF) given by continuous intravenous infusion (CIV) in patients with leukopenia in association with AIDS virus infection. In addition, single dose and steady state pharmacokinetics will also be determined.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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:
- •Met the CDC criteria for the diagnosis of AIDS.
- •Total peripheral blood leukocyte count = or < 3000 cells/mm3 measured on at least two occasions separated by a minimum of one week.
- •Must have or have recovered from one or more opportunistic infection.
- •Serum antibody to HTLV-III/LAV with or without viremia.
- •Anticipated survival of at least 6 months.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •AIDS related complex (ARC).
- •History of malignancy other than Kaposi's sarcoma (KS).
- •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 infections.
- •Presence of renal dysfunction.
- •Other evidence of primary hematologic or infectious disorders unrelated to AIDS virus infection.
- •Patients with the following are excluded:
- •AIDS related complex (ARC).
- •History of malignancy other than Kaposi's sarcoma (KS).
- •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 an opportunistic infection.
- •Dementia or altered mental status that would prohibit the giving and understanding of informed consent.
- •Prior Medication:
- •Any marrow suppressive medications such as trimethoprim-sulfamethoxazole combination (TMP-PurposeX) or Fansidar.
- •Excluded within 6 weeks of study entry:
- •Any investigational drug.
- •Prior Treatment:
- •Excluded within 6 weeks of study entry:
- •Systemic cytotoxic chemotherapy or irradiation.
- •Risk Behavior:
- •Excluded within 3 months of study entry:
- •Regular, excessive use of alcohol, hallucinogens or agents which are addicting.
研究者
研究点 (4)
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