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

Phase 1

• Conditions: Hepatitis C and co-infected with HIV; MedDRA version: 14.1Level: LLTClassification code 10019752Term: Hepatitis C virus (HCV)System Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-021337-31-GB
• Lead Sponsor: Janssen R&D Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-26
• Study Completion: 2013-08-28
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 106

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>- 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 Outcome Measures

Name	Time	Method
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