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

Phase 1

Active, not recruiting

• Conditions: Hepatitis C and co-infected with HIV; MedDRA version: 14.0Level: LLTClassification code 10019752Term: Hepatitis C virus (HCV)System Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-021337-31-ES
• Lead Sponsor: Tibotec Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-27
• Study Completion: 2013-08-28
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Not 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.
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.

Study & Design

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