NCT00002281已完成不适用
An Open Label Phase I/II Study of Recombinant Granulocyte Colony-Stimulating Factor (r-metHuG-CSF) and Recombinant Erythropoietin (rHuEPO) Given Subcutaneously Along With Zidovudine (AZT) to Patients With AIDS or ARC
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 24
- 试验地点
- 2
研究概览
简要总结
To evaluate the safety, tolerance and biological activity of filgrastim (granulocyte colony-stimulating factor; G-CSF) given by daily subcutaneous (SC) injection prior to and concomitantly with erythropoietin (EPO) and zidovudine (AZT) in patients with AIDS or severe AIDS related complex (ARC). To evaluate the safety, tolerance, and biological activity of EPO given 3 times weekly by SC injection concomitantly with G-CSF and prior to and concomitantly with AZT in patients with AIDS or severe ARC. To study the safety and tolerance of 3 dose levels of AZT given to patients with AIDS or severe ARC concomitantly treated with G-CSF and EPO. To study the effect of G-CSF alone and in combination with EPO on HIV replication in vivo as measured by circulating HIV p24 antigen, plasma HIV viremia and semiquantitative HIV cocultures.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Treatment:
- •Radiation or laser therapy to Kaposi's sarcoma lesions provided the dose does not exceed 3000 rads to any one lesion group and/or greater than 10 cm2 total body surface area.
- •Patients must have:
- •A diagnosis of AIDS or AIDS related complex (ARC) as defined by current CDC guidelines.
- •Life expectancy > 6 months.
- •Defined blood cell counts that may be achieved by transfusion.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •History of malignancy other than Kaposi's sarcoma (KS).
- •Presence of > 50 cutaneous KS lesions or progression of KS over the previous 30 days.
- •Presence of opportunistic infection requiring ongoing therapy with known bone marrow suppressive agents.
- •History of cardiovascular disease.
- •History of seizures.
- •HIV related dementia or altered mental status that would prohibit the giving and understanding of informed consent.
- •Presence of iron deficiency anemia as defined by serum ferritin < 30 ng or iron to TIBC ratio < 15 percent.
- •A PT > 15 and a PTT > 40 unless due to a documented circulating lupus anticoagulant.
- •Concurrent Medication:
- •Trimethoprim / sulfamethoxazole.
- •Fansidar.
- •Non-FDA approved antiretrovirals.
- •Hyperimmunization with polio virus.
- •Ribavirin.
- •Isoprinosine.
- •Dextran sulfate.
- •Fu zheng herbs.
- •AL 721 or its congeners.
- •Imuthiol.
- •Interferons.
- •Chronic use of acyclovir (> 10 days out of 30 days).
- •= or > 3g/day oral vitamin C.
- •Patients with the following are excluded:
- •Co-existing conditions and symptoms described in Patient Exclusion Co-existing Conditions.
- •Prior Medication:
- •Excluded within 2 weeks of study entry:
- •Any non-FDA approved drug.
- •Excluded within 4 weeks of study entry:
- •Systemic cytotoxic chemotherapy for Kaposi's sarcoma.
- •Investigational agents.
- •Excluded:
- •Colony stimulating factors.
- •Prior Treatment:
- •Excluded within 4 weeks of study entry:
- •Radiation therapy for Kaposi's sarcoma exceeding 3000 rads to any one lesion group and/or greater than 10 cm2 total body surface area.
- •Risk Behavior:
- •Excluded within 3 months of study entry:
- •Regular excessive use of alcohol, hallucinogens or other psychotropic agents which are possibly addicting.
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
An Open-Label Phase I/II Study of Recombinant Granulocyte Colony Stimulating Factor (r-metHuG-CSF) and Recombinant Erythropoietin (rHuEPO) Given Subcutaneously Along With Zidovudine (AZT) to Patients With the Acquired Immune Deficiency Syndrome (AIDS) or Severe AIDS-Related Complex (ARC)HIV InfectionsNCT00002255Amgen
已完成
1 期
A Phase I - II Safety Study of Filgrastim (Neupogen) to Improve Left Ventricular Function After Severe Acute Myocardial InfarctionAcute Myocardial InfarctionNCT00215124The Cleveland Clinic
已完成
3 期
Reduced Dose of Pegfilgrastim as Support for Chemotherapy for Breast CancerNeutropeniaNCT05283616Cancer Institute and Hospital, Chinese Academy of Medical Sciences122
已完成
1 期
A Phase I Study of the Combination of Recombinant GM-CSF, AZT, and Chemotherapy (ABV) (Adriamycin, Bleomycin, Vincristine) in AIDS and Kaposi's SarcomaSarcoma, KaposiHIV InfectionsNCT00000681National Institute of Allergy and Infectious Diseases (NIAID)24
已完成
1 期
A Phase I Trial of Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (rHuGM-CSF), Recombinant Alpha Interferon and Azidothymidine (AZT) in AIDS-Associated Kaposi's SarcomaSarcoma, KaposiHIV InfectionsNCT00000694National Institute of Allergy and Infectious Diseases (NIAID)18