NCT00004987Unknown1 期
Intraperitoneal Dextrin Sulfate in Patients With Advanced HIV Disease: A Phase I Trial
Steinhart Medical Associates2 个研究点 分布在 1 个国家开始时间: 1999年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to look at the safety and effectiveness of dextrin sulfate in AIDS patients who have failed conventional anti-HIV treatment.
详细描述
Patients have intraperitoneal (IP) catheter placement done at study entry. Infusion with the carrier vehicle (icodextrin 4%) begins 2 weeks later, and 2 days after that, treatment with dextrin sulphate (DS) commences. DS is given three times per week. A nurse delivers initial treatments and the patient and caregiver will be trained to give subsequent treatments until DS has been given a total of 8 weeks. Patient evaluations are done regularly during treatment and observation continues for 24 weeks.
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 may be eligible for this trial if they:
- •Are HIV-positive.
- •Have been diagnosed with AIDS and are under treatment to prevent opportunistic (AIDS-related) infection.
- •Have had a CD4 cell count greater than 50 microL for at least the past 3 months.
- •Have had a viral load of at least 50,000 copies/ml for at least the past 3 months.
- •Have used up all other treatment options.
- •Are able to understand and give written consent.
排除标准
- •Patients may not be eligible for this trial if they:
- •Have been in any other study in the 6 weeks before beginning this study.
- •Have an active, opportunistic infection or other infection.
- •Have any other long-term medical condition or nervous disorder that might make it difficult for them to finish the study.
研究者
研究点 (2)
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