Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4
Open, Randomized, Multicenter Phase IV Study to Evaluate Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Patients Genotype 1 and/or 4
A study concerning viral kinetic with 10 co-infected HIV-HCV patients on treatment with peginterferon alfa-2a + ribavirin o IFN + ribavirin was reported in Conference on Retroviruses and Opportunistic Infections 2002 by Dr. Torriani shown half-life of HCV virions and the viral clearance was larger than mono-infected patients.
The doubt is if this difference in viral kinetic of HIV-HCV co-infected patients versus mono-infected is related with the loss of profited on treatment.
In the APRICOT trial patients genotype 2/3 were treated for 48 weeks and the relapse rates was only 2%.
The present study want to evaluate is the treatment extent for 24 weeks more in patients genotype 1 and/or 4 will be improve the percentage of patients with viral clearance at the end of the follow-up period, to prevent relapsed in patients with response at the end of treatment.
Patients will be randomized to received 180 µg/week of peginterferon alfa-2a + 1000-1200 mg/day of ribavirin during 24 weeks more or control.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Barcelona、西班牙、08025
- Hospital Santa Creu i Sant Pau
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Cádiz、西班牙、11009
- Hospital Puerta Del Mar
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Granada、西班牙、18013
- Hospital Clinico Universitario San Cecilio
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Madrid、西班牙、28040
- Hospital Clínico San Carlos
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Madrid、西班牙、28046
- Hospital La Paz
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Madrid、西班牙、28041
- Hospital 12 De Octubre
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Sevilla、西班牙、41013
- Hospital Virgen del Rocio
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Sevilla、西班牙、41014
- Hospital De Valme
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Sevilla、西班牙、41008
- Hospital Virgen Macarena
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Valencia、西班牙、46014
- Consorcio Hospital General
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Valladolid、西班牙、47011
- Hospital Clínico de Valladolid
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Alava
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Vitoria、Alava、西班牙、01009
- Hospital de Txagorritxu
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Barcelona
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Hospitalet de Llobregat、Barcelona、西班牙、08907
- Hospital de Bellvitge
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Cádiz
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Jerez de la Frontera、Cádiz、西班牙、11407
- Hospital de Jerez
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Gran Canaria
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Las Palmas、Gran Canaria、西班牙、35016
- Hospital Insular
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Guipúzcoa
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San Sebastián、Guipúzcoa、西班牙、20014
- Hospital De Donostia
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La Coruña
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Santiago、La Coruña、西班牙、15705
- Complejo Hospitalario Universitario
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Madrid
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Alcorcón、Madrid、西班牙、28922
- Fundacion Hospital de Alcorcon
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Mallorca
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Palma de Mallorca、Mallorca、西班牙、07014
- Hospital Son Dureta
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients on treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day) who are RNA-HCV undetectable at 44 week
- RNA-HCV positive at 48 week before study and genotype 1 or 4.
- HIV-1 positive: ELISA y Western-blot.
- Stable status of HIV-1 infection in the opinion of the investigator, (patients who are not expected to progress during the study).
- Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 6 months after treatment end. This may include, but is not limited to, using birth control pills, IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state.
- Willingness to give written informed consent and willingness to participate to and comply with the study.
Exclusion Criteria:
- Patients with RNA-HCV detectable after 44 weeks of treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day).
- Patients with other treatment for chronic hepatitis, different which of inclusion criteria is described.
- More of tree weeks from the end of treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day) to the inclusion in "EXTRADOS" trial.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:2个
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实验性的:1
Peginterferon alfa-2a 180 mcg/week + 1000-1200 mg/day ribavirin during 24 weeks
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Peginterferon alfa-2a 180 mcg/week ribavirin 1000-1200 mg/day during 24 weeks
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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% of patients with RNA-HCV undetectable
大体时间:at 48 week of study (24 weeks after the end of treatment period of trial).
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at 48 week of study (24 weeks after the end of treatment period of trial).
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次要结果测量
结果测量 |
大体时间 |
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% of percentage of patients with RNA-HCV undetectable
大体时间:24 weeks of trial period
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24 weeks of trial period
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合作者和调查者
调查人员
- 学习椅:José Hernández-Quero, Dr、Hospital Clinico Universitario San Cecilio
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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