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临床试验/NCT00194857
NCT00194857终止4 期

A Randomized Clinical Trial Comparing Two Management Strategies for Treatment of Neutropenia and Anemia Associated With Pegylated Interferon Plus Ribavirin Treatment of Compensated Chronic Hepatitis C in Adult Subjects Infected With HIV.

Weill Medical College of Cornell University2 个研究点 分布在 1 个国家开始时间: 2002年2月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
终止
试验地点
2
主要终点
change in hemoglobin

研究概览

简要总结

This study is designed to test two separate strategies for treatment of anemia (low hemoglobin) and neutropenia (low white blood cells) in HIV/HCV coinfected patients who are being treated with pegylated interferon and ribavirin.

详细描述

This is a multi-center, randomized, open-labeled trial in subjects co-infected with hepatitis C (HCV) and human immunodeficiency virus type 1 (HIV-1) who are naïve to anti-HCV therapy. Subjects will receive PEG interferon alfa-2b (PEG-IFN) 1.5 mcg/kg/week administered once weekly plus ribavirin (RBV) 13 + 2 mg/kg/day. The goal of this study is to evaluate two different treatment options for anemia and neutropenia associated with the initiation of pegylated interferon and ribavirin. This will result in completion of therapy, and possibly a better viral sustained response.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • hemoglobin > 11
  • absolute neutrophil count >1,200
  • naive to peg interferon and ribavirin

排除标准

  • Prior treatment for hepatitis C
  • Pregnant or nursing

结局指标

主要结局

change in hemoglobin

change in absolute neutrophil count

次要结局

  • HCV RNA
  • depression
  • fatigue

研究者

申办方类型
Other

研究点 (2)

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