E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C / HIV-1 co-infection |
Coinfección de hepatitis C cronica / VIH -1 |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic Hepatitis C / HIV-1 co-infection |
Coinfección de hepatitis C cronica / VIH -1 |
|
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 | 10008912 |
E.1.2 | Term | Chronic hepatitis C |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
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 assess efficacy, as determined by the proportion of subjects with SVR12, defined as HCV RNA < Limit of quantification (LOQ) detectable or undetectable, at post-treatment Week 12. |
Evaluar la eficacia, determinada por el porcentaje de sujetos con RVS12, definida como ARN del VHC < LDC (detectable o indetectable) en la semana 12 después del tratamiento. |
|
E.2.2 | Secondary objectives of the trial |
? To assess the proportion of subjects with genotype 1 infection who achieve : -HCV RNA < LOQ (detectable or undetectable) -HCV RNA undetectable at weeks: 1, 2, 4, 6, 8, and 12; both Weeks 4 and 12; EOT, post-treatment Week 24 (SVR24); and post-treatment Week 48 (SVR48) for subjects who achieve VR (4&12) ? To assess safety, as measured by the frequency of SAEs and discontinuations due to AEs ? To assess the proportion of subjects who are receiving HAART and who maintain their HIV RNA < 40 copies/mL and the proportion of subjects who experience confirmed HIV RNA ? 400 copies/mL at end of treatment for subjects who are receiving HAART ? To assess the relationship between efficacy and the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene |
?Evaluar el porcentaje de sujetos con infección por el genotipo 1 que logran tener ARN del VHC < LDC (detectable o indetectable) y ARN del VHC indetectable en las semanas: 1, 2, 4, 6, 8, y 12; semanas 4 y 12; FDT, semana 24 (RVS24) postratamiento; y semana 48 postratamiento (RVS48) en sujetos que alcancen una RV (4 y 12).
? Evaluar la seguridad, determinada por la frecuencia de AAG e interrupciones debidas a AA; ? Evaluar el porcentaje de sujetos que están recibiendo TARGA y mantienen su ARN del VIH < 40 copias/ml y el porcentaje de sujetos que están recibiendo TARGA en los que se confirma ARN del VIH ? 400 copias/ml al final del tratamiento; ? Evaluar la asociación entre la eficacia y los polimorfismos de un solo nucleótido (SNP) rs12979860 del gen de IL-28B. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
?Males and females, 18 to 70 years of age; ?HCV Genotype 1a or 1b; ?HCV-Treatment naive; ?HCV RNA > 10,000 IU/mL at screening; ?HIV-1 infection;(approximately 250 subjects receiving HAART, up to 50 subjects not receiving HAART); ?For subjects receiving HAART, HIV RNA must be below < 40 copies/mL at screening and must be < 400 copies/ml for at least 6 months prior to screening; |
o Hombres y mujeres, de 18 a 70 años; o Sujetos infectados de forma crónica por el genotipo 1 del VHC (al menos un 40% de cada subtipo, 1a o 1b), o Tratamiento naive para VHC o ARN del VHC > 10.000 UI/ml en la selección; o Infección por el VIH-1 (unos 250 sujetos que recibirán TARGA, y hasta 50 que no recibirán TARGA). o En los sujetos que estén recibiendo TARGA, el ARN del VIH tiene que ser < 40 copias/ml en la selección, y debe ser < 400 copias/ml durante al menos 6 meses antes de la selección; |
|
E.4 | Principal exclusion criteria |
?Subjects (receiving HAART) who had first initiated anti-retroviral therapy within the last 6 months of Day 1; ?Subjects (receiving HAART) who have changed their anti-retroviral regimen within the last 3 months prior to Day 1 (other than prohibited HAART regimens (see section 3.4.1), which may be substituted at least one month prior to Day 1); ?Use of prohibited HAART;regimens (see section 3.4.1) within one month of Day 1 and throughout the treatment period of the trial; ?Laboratory values: neutrophil count < 1500 cells/?L (<1200 cells/ ?L for blacks), platelet count < 90,000 cells/?L, hemoglobin < 11 g/dL for females, hemoglobin < 12 g/dL for males; ?Total bilirubin ? 34 ?mol/L (or ? 2 mg/dL) unless subject has a documented history of Gilbert?s disease or antiretroviral regimen contains atazanavir. |
? Sujetos (que reciben TARGA) que hayan iniciado el primer tratamiento antirretroviral en los 6 meses anteriores al día 1; ? Sujetos (que reciben TARGA) que hayan cambiado su pauta antirretroviral en los 3 meses anteriores al día 1 (a excepción de las pautas de TARGA prohibidas ? Uso de de pautas de TARGA prohibidas en el mes anterior al día 1 y durante todo el periodo de tratamiento del ensayo; ? Hallazgos en la exploración física y en las determinaciones de laboratorio a) Bilirrubina total > o = 34 micromol/l (> o = 2 mg/dl) confirmada excepto si el sujeto tiene antecedentes documentados de enfermedad de Gilbert o un tratamiento antirretroviral que contenga atazanavir; b) Plaquetas < o = 90 x 109/l, confirmado; c) RAN < o = 1,5 x 109/l confirmado (RAN < o = 1,2 x 109/l en sujetos de raza negra, confirmado); d) Hemoglobina < o = 11 g/dl en las mujeres y < o = 12 g/dl en los varones, confirmada; |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects with SVR12, defined as HCV RNA < LOQ (detectable or undetectable) at post-treatment Week 12 |
El criterio principal de valoración de la eficacia es la tasa de RVS12, definida como ARN del VHC < LDC (detectable o indetectable) en la semana 12 después del tratamiento. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Follow-up Week 12 |
Seguimiento semana 12 |
|
E.5.2 | Secondary end point(s) |
1. To assess the proportion of subjects with Genotype 1 infection who achieve HCV RNA < LOQ (detectable or undetectable) at weeks: 1, 2, 4, 6, 8, and 12; both Weeks 4 and 12; EOT, post-treatment Week 24 (SVR24); and post-treatment Week 48 (SVR48) for subjects who achieve VR (4&12). 2. To assess the proportion of subjects with Genotype 1 infection who achieve HCV RNA undetectable at weeks: 1, 2, 4, 6, 8 and 12; both Weeks 4 and 12; EOT, post-treatment Week 12; post-treatment Week 24; and post-treatment Week 48 for subjects who achieve VR (4&12). 3. To assess safety, as measured by the frequency of SAEs and discontinuations due to AEs; 4. To assess the proportion of subjects who are receiving HAART and who maintain their HIV RNA < 40 copies/mL and the proportion of subjects who experience confirmed HIV RNA ? 400 copies/mL at end of treatment for subjects who are receiving HAART; 5. Proportion of subjects with SVR12 at post treatment Week 12 by the rs12979860 in the IL28B gene. |
? Porcentaje de sujetos con infección por el genotipo 1 que logran tener ARN del VHC < LDC (detectable o indetectable) en las semanas: 1, 2, 4, 6, 8, y 12; semanas 4 y 12; FDT, semana 24 después del tratamiento (RVS24) y semana 48 después del tratamiento (RVS48) en los sujetos que alcancen una RV (4 y 12). ? Porcentaje de sujetos con infección por el genotipo 1 que logran tener ARN del VHC indetectable en las semanas: 1, 2, 4, 6, 8, y 12; semanas 4 y 12; FDT, o en la semana 12 o la semana 24 después del tratamiento, y semana 48 después del tratamiento (RVS48) en los sujetos que alcancen una RV (4 y 12) ? Evaluar la seguridad midiendo la frecuencia de AAG y abandonos debidos a AA hasta el final del tratamiento (48 semanas como máximo) más 30 días ? Porcentaje de sujetos que están recibiendo TARGA y mantienen su ARN del VIH < 40 copias/ml y porcentaje de sujetos que están recibiendo TARGA en los que se confirma ARN del VIH > o = 400 copias/ml al final del tratamiento (48 semanas como máximo) ? Porcentaje de sujetos con RVS12 en la semana 12 postratamiento por SNP rs12979860 del gen de IL28 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. On-treatment Weeks 1, 2, 4, 6, 8, 12, EOT, post-treatment Week 24 and post-treatment Week 48 for subjects who achieve VR (4 & 12). 2. On-treatment Weeks 1, 2, 4, 6, 8, 12, EOT, post-treatment Weeks 12, 24 and post-treatment Week 48 for subjects who achieve VR (4 &12). 3. Throughout treatment period 4. End of treatment 5. Post-treatment Week 12 |
? Semanas de tratamiento 1, 2, 4, 6, 8, 12, Fin de tratamiento, semana 24 post-tratamiento y semana 48 post-tratamiento para sujetos con VR (4 & 12). ? Semanas de tratamiento 1, 2, 4, 6, 8, 12, Fin de tratamiento, semana 12, 24 post-tratamiento y semana 48 post-tratamiento para sujetos con VR (4 & 12). ? Durante el periodo de tratamiento ? Fin de tratamiento ? Semana post-tratamiento |
|
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 | Yes |
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 | Yes |
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 |
HCV and HIV Resistance Testing; Exploratory Biomarker Assessments |
Evaluación de resistencias a VHC y VIH; evaluaciones exploratorias de biomarcadores. |
|
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 28 |
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 |
Argentina |
Australia |
Belgium |
Brazil |
Canada |
France |
Germany |
Italy |
Puerto Rico |
Russian Federation |
Spain |
United Kingdom |
United States |
|
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
|
LPLV |
Última visita del último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |