NCT00002218已完成1 期
A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients
Parke-Davis11 个研究点 分布在 1 个国家目标入组 40 人开始时间: 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
- 入组人数
- 40
- 试验地点
- 11
研究概览
简要总结
To determine the maximum tolerated dose of CI-1012 in late-stage HIV-1-infected patients. To determine the antiretroviral activity of CI-1012 when added to combination therapy. To assess the multiple-dose pharmacokinetic characteristics of CT-1012 when added to combination therapy. To assess the effect of CI-1012 on the pharmacokinetics of other antiretroviral agents.
详细描述
Doses are escalated based on safety assessments: As soon as a dose meets the criteria for "tolerated" or "not tolerated", doses are escalated or terminated, respectively. All patients are treated for 2 weeks, with follow-up visits scheduled 1 week and 1 month post-treatment.
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:
- •Serological evidence of late-stage HIV-1 infection (ELISA and Western Blot).
- •CD4 T cell count less than or equal to 200 mm
- •HIV-1 RNA greater than or equal to 5,000 copies/mL.
排除标准
- •Prior Medication:
- •Anti-HIV treatment within 8 weeks prior to entry.
- •Systemic steroids within 4 weeks prior to entry.
- •Prior Treatment:
- •Treatment with anticancer agents within 4 weeks prior to study.
研究者
研究点 (11)
Loading locations...
相似试验
已完成
1 期
A Study of CI-1012 in HIV-Infected PatientsHIV InfectionsNCT00002196Parke-Davis32
已完成
1 期
Phase I Trial of S-1153 in Patients With HIV InfectionHIV InfectionsNCT00002214Lexigen Pharmaceuticals40
Unknown
1 期
Study of Single IV Administration of P2G12HIV InfectionNCT02923999St George's, University of London18
尚未招募
1 期
Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIVHuman Papilloma VirusHuman Immunodeficiency VirusAnal Intraepithelial NeoplasiaHigh-Grade Squamous Intraepithelial LesionsNCT06233331Emory University9
Unknown
1 期
Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)Esophageal CancerNCT00915850Wakayama Medical University32