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临床试验/NCT00055185
NCT00055185已完成2 期

Safety and Efficacy of PRO 542 in the Treatment of HIV-Infected Patients

Progenics Pharmaceuticals, Inc.1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2003年4月最近更新:
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

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

申办方类型
Industry

研究点 (1)

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