TMC435-TiDP16-C212 - Trial of TMC435 in Genotype 1 Hepatitis C and Human Immunodeficiency Virus Co-Infected Patients.

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).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021337-31-GB

Enrollment

100

Registered

2011-07-26

Start date

2011-11-03

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C and co-infected with HIV MedDRA version: 14.1 Level: LLT Classification code 10019752 Term: Hepatitis C virus (HCV) System Organ Class: 10022891 - Investigations

Interventions

Product Name: JNJ-38733214-AAA - capsule , hard - 150mg Product Code: TMC435 (or R494617) Pharmaceutical Form: Capsule, hard INN or Proposed INN: simeprevir CAS Number: 923604-59-5 Current Sponsor cod

Eligibility

Sex/Gender

All

Inclusion criteria

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 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

Exclusion criteria

Exclusion 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 or if not on medication for HIV infection, are unlikely to require treatment initiation in the next 12 months.

Design outcomes

Primary

Measure	Time frame
Main Objective: - To evaluate the safety and tolerability of TMC435 plus PegIFNa-2a and RBV triple therapy in HCV genotype-1 infected subjects, co-infected with HIV-1. - To evaluate the proportion of subjects with SVR 12 weeks after the planned end of treatment (SVR12).;Secondary Objective: See Protocol Section 2.1 Objectives p.37-38;Primary end point(s): proportion of subjects with sustained virologic response – undetectable HCV RNA (<25 IU/ml undetectable);Timepoint(s) of evaluation of this end point: 12 weeks after planned end of treatment	—

Measure

Time frame

Main Objective: - To evaluate the safety and tolerability of TMC435 plus PegIFNa-2a and RBV triple therapy in HCV genotype-1 infected subjects, co-infected with HIV-1. - To evaluate the proportion of subjects with SVR 12 weeks after the planned end of treatment (SVR12).;Secondary Objective: See Protocol Section 2.1 Objectives p.37-38;Primary end point(s): proportion of subjects with sustained virologic response – undetectable HCV RNA (<25 IU/ml undetectable);Timepoint(s) of evaluation of this end point: 12 weeks after planned end of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): See Protocol Section 11.4.2 Secondary Efficacy Endpoints p89;Timepoint(s) of evaluation of this end point: See Protocol Section 11.4.2 Secondary Efficacy Endpoints p89	—

Countries

Canada, France, Germany, Portugal, Spain, United Kingdom, United States

Contacts

Public ContactJanssen Biologics BV

Janssen-Cilag International NV - Clinical Registry Group

ClinicalTrialsEU@its.jnj.com+31071524 2166

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026