E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hepatitis C and co-infected with HIV |
Hepatitis C y co-infectados por el Virus de Inmunodeficiencia Humana (VIH) |
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E.1.1.1 | Medical condition in easily understood language |
Hepatitis C and co-infected with HIV |
Hepatitis C y co-infectados por el Virus de Inmunodeficiencia Humana (VIH) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019752 |
E.1.2 | Term | Hepatitis C virus (HCV) |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety and tolerability of TMC435 in combination with pegylated interferon alpha-2a (PegIFN?- 2a)/ribavirin (RBV) in HCV genotype-1 infected subjects, co-infected with HIV-1. To evaluate the proportion of subjects with sustained virologic response (SVR) 24 weeks after the planned end of treatment (SVR24). |
Ealuar la seguridad, la tolerabilidad y la eficacia de TMC435 en combinación con interferon pegilado alpha-2a (PegIFN?- 2a)/ribavirin (RBV) en pacientes infectados por el genotipo 1 del virus de la hepatitis C (VHC) co-infectados por el virus de la inmunodeficiencia humana (VIH-1). Evaluar la proporción de pacientes con respuesta virológica sostenida (RVS) 24 semanas después del final previsto del tratamiento (RVS24). |
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E.2.2 | Secondary objectives of the trial |
See Protocol Section 2.1 Objectives p.30 |
Ver sección del protocolo 2.1 Objetivos P.30 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
Infección hepatitis C Genotipo 1 (Confirmado en la visita de selección); infección documentada por VIH-1 (virus de inmunodeficiencia humana 1); deben estar de acuerdo en utilizar 2 métodos efectivos de contracepción a lo largo del estudio (tanto varones como mujeres); deben encontrarse en un régimen estable de tratamientos para VIH permitidos por el protocolo durante al menos 4 semanas antes de la visita de selección. |
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E.4 | Principal 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. |
Hepatitis C no genotipo 1; enfermedad del hígado no relacionada a infección hepática C, co-infeccion con virus hepatitis B, infección primaria VIH-1 o VIH-2; cualquier enfermedad actual definitoria de SIDA ( Sindrome adquirido de inmunodeficiencia humana); descompensación hepática, importantes anormalidades de laboratorio u otras enfermedades activas, estar embarazada o planear quedarse embarazada. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Sustained virologic response - Undetectable HCV RNA (<25 IU/ml undetectable) |
Respuesta virológica sostenida (RVS) - ARN del VHC indetectable (< 25 UI/ml indetectables) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 weeks after planned end of treatment |
24 semanas después del final previsto del tratamiento |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
tolerability |
tolerabilidad |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
France |
Germany |
Portugal |
Spain |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LSLV |
Última visita del último paciente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |