NCT00055185已完成2 期
Safety and Efficacy of PRO 542 in the Treatment of HIV-Infected Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to determine any adverse effects of PRO 542 after administration and to determine the anti-HIV effects of PRO 542 in the patient.
详细描述
A 2 arm study involving a series of 3 triweekly doses of PRO 542. One arm will involve patients on a stable dose of anti-retroviral therapy and the other arm will consist of patients not receiving anti-retroviral therapy. Three patients will be enrolled in each arm followed by a safety evaluation. Following the safety evaluation, 3 more patients may be enrolled in each arm. After the first 12 patients, an additional 12 patients may be enrolled pending safety data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Confirmed diagnosis of HIV
- •Patients must be on a stable dose of acceptable anti-HIV therapy or receiving no anti-HIV therapy for at least four (4) weeks prior to the start of this study
- •HIV-1 determination by RNA-PCR greater than or equal to 100,000 copies/ml
- •CD4 count >50/cubic mm at screening
排除标准
- •Patients who have previously received PRO 542
- •Patients with active, significant infection (other than HIV) not controlled by antibiotics
- •Pregnant or lactating women
- •Patients with an estimated life expectancy of <3 months
- •Patients currently receiving steroids or other immunosuppressive therapy or immunoglobulin therapy except for topical or inhaled steroids
- •Patients with known allergy or hypersensitivity to PRO 542 or immunoglobulin preparations
研究者
研究点 (1)
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