NCT00002087已完成1 期
Safety, Tolerance, Efficacy and Pharmacokinetics of Multiple Doses of sCD4-PE40 in the Treatment of HIV-Infected Individuals
Pharmacia and Upjohn2 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
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
To investigate the safety and tolerance of an increasing number of infusions per week of alvircept sudotox ( sCD4-PE40; soluble CD4-Pseudomonas exotoxin ) at a fixed dose when administered to HIV-1-infected individuals. To investigate the effect of sCD4-PE40 on the following parameters: T lymphocyte subsets, plasma HIV RNA and cellular HIV proviral DNA in PBMC and CD4 cells, p24 levels, serum beta-2 microglobulin, and neopterin levels.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •HIV positivity confirmed by Western blot.
- •CD4 count of 100 - 500 cells/mm3 on a morning draw within 3 weeks prior to study entry.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms and conditions are excluded:
- •Concurrent neoplasms other than basal cell carcinoma of the skin, in situ carcinoma of the cervix, or nondisseminated Kaposi's sarcoma.
- •Hemophilia or other clotting disorders.
- •Major organ allograft.
- •Significant cardiac, hepatic, renal, or CNS disease.
- •Prior Medication:
- •Antiretroviral agents within 2 months prior to study entry.
- •Known anti-HIV medication within 60 days prior to study entry.
- •Prior immunomodulators (e.g., systemic steroids, interferons, or interleukins) or other chemotherapy.
- •Prior Treatment:
- •Prior radiation therapy. Active substance abuse.
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Phase I, Dose-Escalating Safety and Tolerance Study of sCD4-PE40 in HIV-Infected PersonsHIV InfectionsNCT00000743National Institute of Allergy and Infectious Diseases (NIAID)64
已完成
1 期
Study of Intravenous Aflibercept in Combination With FOLFIRI in Japanese Patients With Metastatic Colorectal CancerNeoplasm MetastasisColorectal NeoplasmsNCT00921661Sanofi16
Unknown
1 期
A Phase I Study of AL8326 in Advanced Solid TumorAdvanced Solid TumorsNCT04890587Advenchen Laboratories Nanjing Ltd.40
已完成
1 期
PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic MalignanciesAcute Myelogenous LeukemiaB-cell Acute Lymphoblastic LeukemiaBlastic Plasmacytoid Dendritic Cell NeoplasmChronic Myeloid Leukemia, Blast CrisisNCT02730312Xencor, Inc.120
已完成
1 期
Study Evaluating The Safety And Tolerability Of ILV-094 In Subjects With PsoriasisPsoriasisNCT00563524Wyeth is now a wholly owned subsidiary of Pfizer76