NCT00002070已完成3 期
Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
Schering-Plough14 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
- 14
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 (14)
Loading locations...
相似试验
已完成
1 期
Granulocyte-Macrophage Colony-Stimulating Factor and Zidovudine: A Phase I Study of Concurrent Administration in Patients With AIDS and Severe ARCHIV InfectionsCytopeniasNCT00000711National Institute of Allergy and Infectious Diseases (NIAID)60
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 SarcomaHIV InfectionsSarcoma, KaposiNCT00000681National Institute of Allergy and Infectious Diseases (NIAID)24
已完成
不适用
The Safety and Effectiveness of Ganciclovir Used Alone or in Combination With Granulocyte-Macrophage Colony Stimulating Factor in the Treatment of Cytomegalovirus (CMV) of the Eye in Patients With AIDSCytomegalovirus RetinitisHIV InfectionsNCT00000989National Institute of Allergy and Infectious Diseases (NIAID)50
已完成
1 期
Phase I Trial of mBACOD and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in AIDS-Associated Large Cell, Immunoblastic, and Small Non-cleaved LymphomaLymphoma, Non-HodgkinHIV InfectionsNCT00000689National Institute of Allergy and Infectious Diseases (NIAID)18
已完成
1 期
Filgrastim, Cladribine, Cytarabine, and Mitoxantrone With Sorafenib in Treating Patients With Newly-Diagnosed, Acute Myeloid Leukemia or High-Risk Myelodysplastic SyndromeMyeloproliferative Neoplasmde Novo Myelodysplastic SyndromeAcute Biphenotypic LeukemiaAcute Myeloid LeukemiaMyelodysplastic SyndromeNCT02728050University of Washington84