A Phase III open-label study to evaluate the safety, tolerability and efficacy of TMC435 plus PegIFNa-2a (Pegasys) and ribavirin (Copegus) triple therapy in chronic hepatitis C genotype-1 infected subjects who are co-infected with human immunodeficiency virus type 1 (HIV-1).

Janssen R&D Ireland0 个研究点目标入组 100 人开始时间: 2011年8月30日最近更新: 2014年2月10日

试验速览

暂无简介。

•Genotype 1 hepatitis C infection (confirmed at screening); Documented HIV-1 (human immunodeficiency virus 1) infection; must agree to use 2 forms of effective contraception throughout study (both males and females); must be on a stable regimen of the protocol-allowed HIV treatments for at least 4 weeks prior to screening or if not on medication for HIV infection, are unlikely to require treatment initiation in the next 12 months.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 98
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•Genotype 1 hepatitis C infection (confirmed at screening); Documented HIV-1 (human immunodeficiency virus 1) infection; must agree to use 2 forms of effective contraception throughout study (both males and females); must be on a stable regimen of the protocol-allowed HIV treatments for at least 4 weeks prior to screening or if not on medication for HIV infection, are unlikely to require treatment initiation in the next 12 months.

发起方

Janssen R&D Ireland