NCT00002070已完成3 期
Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
Schering-Plough28 个研究点 分布在 1 个国家开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 28
研究概览
简要总结
To determine whether co-administration of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) improves tolerance to ganciclovir in patients previously intolerant because of neutropenia defined as an absolute neutrophil count less than 500 cells/mm3. To assess if improved tolerance of ganciclovir is associated with a favorable outcome as defined by a delayed time to progression of retinitis; to confirm the safety and co-administration of ganciclovir and GM-CSF; to assess the changes in the expression of HIV p24 antigen in the serum and number of T4+ lymphocytes in the blood of patients receiving ganciclovir with or without GM-CSF.
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
- •Patient must have the following:
- •AIDS as defined by CDC criteria.
- •Retinitis as diagnosed by the study ophthalmologist.
- •Performance status 0, 1, or
- •Ability to give informed consent and suitability of intravenous access for scheduled blood tests.
- •Patient may have Kaposi's sarcoma or basal skin cancer.
排除标准
- •Co-existing Condition:
- •Patients with the following are excluded:
- •Active acute infection requiring treatment.
- •Corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy.
- •Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer.
- •Patients with the following are excluded:
- •Active acute infection requiring treatment.
- •Corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy.
- •Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer.
- •Prior Medication:
- •Granulocyte macrophage colony-stimulating factor (GM-CSF).
- •Colony stimulating factor.
- •Interleukin
- •Excluded within 7 days of study entry:
- •Zidovudine (AZT).
- •Trimethoprim / sulfamethoxazole (TMP / SMX).
- •Pyrimethamine.
- •Excluded within 30 days of study entry:
- •Biologic response modifiers.
- •Cytotoxic agents.
- •Investigational agents.
- •Prior Treatment:
- •Radiation therapy.
- •Required within 1 week of study entry:
- •One or more doses of ganciclovir.
研究者
研究点 (28)
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