A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pivotal Clinical Study Evaluating the Safety and Efficacy of WF10 (TCDO) Intravenous Solution in the Management of Patients With Late-Stage HIV Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 59
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give WF10 to adults with late-stage HIV disease. WF10 is suspected to help the immune system fight infection and slow HIV disease progression.
详细描述
Patients are randomized to 1 of 2 treatment groups to receive 4 IV treatment cycles of either WF10 or control (physiological saline solution). Patients are monitored throughout the study for: a) clinical progression; b) number, duration, and cause of hospitalizations; c) quality of life; and d) density of CD38 antigen on CD8+ T cells. Patients receive treatment for 11 weeks but will continue to be followed for a maximum of 96 weeks. During the follow-up period, patients are evaluated initially at Week 18, then at Weeks 24, 36, and 48. If the study is continued beyond Week 48, follow-up visits are conducted at Weeks 72 and 96.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
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 study if they:
- •Are HIV-positive.
- •Have a CD4 cell count of less than 50 cells/mm3 within 14 days prior to study entry.
- •Are at least 18 years old.
- •Have received anti-HIV drugs at some time in the past.
- •Agree to practice abstinence or use effective methods of birth control, including the pill, during the study.
排除标准
- •Patients will not be eligible for this study if they:
- •Are being treated for any form of cancer within 30 days of study entry.
- •Have ever received an HIV vaccine.
- •Have received steroids within 30 days prior to study entry. (Note: Testosterone is allowed.)
- •Have received certain medications, including anti-HIV treatments that are not approved by the FDA.
- •Have participated in another WF10 study.
- •Have an illness or any condition that might exclude them from this study.
- •Are pregnant or breast-feeding.
- •Abuse drugs or medications.
- •Received a blood transfusion within 45 days prior to study entry.