NCT00002006已完成1 期
A Phase I/II Pilot Study of Simultaneously Administered Rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility
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
- 2
研究概览
简要总结
To assess the safety and efficacy of subcutaneously administered sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the neutrophil count in HIV-infected adults who have developed neutropenia as a result of receiving the antiretroviral agent, zidovudine ( AZT ). To assess the safety and efficacy of subcutaneously administered GM-CSF in increasing and maintaining the neutrophil count in HIV-infected adults with pre-existing neutropenia who are at high risk of developing hematologic intolerance while receiving the antiretroviral agent, AZT, for the first time. To assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated infectious complications.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Treatment:
- •Minimal local irradiation for tumors.
- •Patients must have:
- •Diagnosis of AIDS or AIDS related complex (ARC).
- •Neutropenia, due either to zidovudine (AZT) or HIV infection.
- •Life expectancy = or > 6 months.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Significant malabsorption as defined by greater than 10 percent weight loss and one or more of the following:
- •Serum carotene less than 75 IU/ml.
- •Vitamin A level less than 75 IU/ml.
- •More than 4 foul-smelling or greasy stools per day.
- •Other criteria of malabsorption.
- •Kaposi's sarcoma (KS) or other tumor which is likely to require specific antitumor therapy during study, other than minimal local irradiation.
- •Active, life-threatening infection with bacterial, viral, fungal, or protozoan pathogens or fever of 39 degrees C within 10 days of study entry, unless it is apparent that the fever is not due to a severe underlying infection.
- •Concurrent Medication:
- •Excluded within 4 weeks of study entry:
- •Any investigational drug.
- •Immunomodulating agents.
- •Hormonal therapy.
- •Cytolytic chemotherapeutic agents.
- •Antiretroviral agent other than zidovudine (AZT).
- •Excluded within 4 months of study entry:
- •Excluded within 3 months of study entry:
- •Ribavirin.
- •Patients with the following are excluded:
- •Significant malabsorption.
- •Tumor likely to require specific antitumor therapy during study.
- •Other significant medical problems and conditions specified in Patient Exclusion Co-Existing Conditions.
- •Uncorrected nutritional deficiencies that may contribute to neutropenia.
- •Hypersensitivity to zidovudine (AZT) or other nucleoside analogs.
- •Profound dementia or altered mental status that would prohibit the giving of informed consent.
- •Prior Treatment:
- •Excluded within 1 month of study entry:
- •Transfusion.
- •Excluded within 4 weeks of study entry:
- •Radiation therapy to greater than 100 cm2 body area.
- •Current drug or alcohol abuse. Unprotected sexual behavior or other activities which might introduce a new inoculation of HIV during the study.
- •Patients must be willing to refrain from unprotected sexual or other activities which might introduce a new inoculum of HIV during the study.
研究者
研究点 (2)
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