EUCTR2010-021337-31-ESActive, not recruitingPhase 1
A Phase III open-label study to evaluate the safety, tolerability and efficacy of TMC435 plus PegIFN?-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).
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Tibotec Pharmaceuticals
- Enrollment
- 106
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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.
- •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
Exclusion Criteria
- •Non genotype 1 hepatitis C; liver disease not related to hepatitic C infection; co-infection with hepatitis B virus; primary HIV-1 infection or HIV-2 infection; any currently active AIDS (acquired immunodeficiency syndrome) defining illness; hepatic decompensation; significant laboratory abnormalities or other active diseases; pregnant or planning to become pregnant.
Investigators
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