NCT00002007已完成不适用
A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sandoz
- 试验地点
- 1
研究概览
简要总结
To evaluate the safety of repeated courses of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) administered subcutaneously to patients with HIV infection and leukopenia. To determine if administration of GM-CSF will prevent some or all of the hematologic toxicity associated with zidovudine ( AZT ) treatment in patients with pre-existing leukopenia. To assess any clinical and/or virologic benefits from administering alternating weeks of GM-CSF and AZT to patients with symptomatic HIV infection who have a history of cytologically confirmed Pneumocystis carinii pneumonia ( PCP ) or a circulating absolute CD4 lymphocyte count less than 200 cells/mm3.
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
- •Patients must have:
- •Serum antibody to HIV with or without evidence of HIV antigenemia.
- •White blood cells (WBC) = or < 4500 cells/mm3 measured on at least 2 occasions separated by a minimum of 1 week.
- •Qualifying indications for AZT therapy.
- •Life expectancy = or > 6 months.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Current or past history of malignancy including Kaposi's sarcoma.
- •Excessive diarrhea or significant malabsorption.
- •If patients have had > 10 percent weight loss within the past 3 months, they should not have malabsorption as evidenced by serum carotene < 75 IU/ml, serum vitamin A < 75 IU/ml, significant malabsorption 4 foul-smelling or greasy stools per day or other criteria.
- •Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (IO).
- •Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP).
- •Active OI requiring systemic treatment.
- •Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia.
- •Concurrent Medication:
- •Excluded within 4 weeks of study entry:
- •Zidovudine (AZT).
- •Other antiviral agent associated with leukopenia.
- •Investigational drug.
- •Immunomodulators.
- •Interferon.
- •Steroids.
- •Excluded within 8 weeks of study entry:
- •Ribavirin.
- •Excluded within 4 months of study entry:
- •Patients with the following are excluded:
- •Current or past history of malignancy including Kaposi's sarcoma.
- •Excessive diarrhea or significant malabsorption.
- •Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (OI).
- •Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP).
- •Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia.
- •Prior Medication:
- •Prophylactic therapy for Pneumocystis carinii pneumonia (PCP) that may cause leukopenia.
- •Risk Behavior:
- •Current drug or alcohol abusers.
- •Unprotected sexual contact or other activities that may result in reinfection with HIV.
- •Patients must be willing to refrain from unprotected sexual contact or other activities that may result in reinfection with HIV.
研究者
研究点 (1)
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