E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HIV–HCV co-infected patients |
Pacientes coinfectados por VIH y VHC genotipo 1 |
|
E.1.1.1 | Medical condition in easily understood language |
HIV and hepatitis C con-infection |
Pacientes infectados con VIH y hepatitis C |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020161 |
E.1.2 | Term | HIV infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065949 |
E.1.2 | Term | HCV coinfection |
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 changes in plasma pharmacokinetic parameters (Cmax, Cmin, AUC0-8, t 12, and Cl) of Telaprevir 750 mg/8h administered with Atazanavir 200 mg/8h not powered, taking as reference the observed pharmacokinetic parameters when given with Atazanavir/ritonavir 300/ 100 mg per day or Raltegravir. |
Evaluar los cambios en los parámetros farmacocinéticos plasmáticos (Cmax, Cmin, AUC0-8, t 1/2, y Cl) de Telaprevir 750 mg/8h administrado junto con Atazanavir 200 mg/12 h no potenciado, tomando como referencia los parámetros farmacocinéticos observados cuando se administra con Atazanavir/ritonavir 300 /100 mg día o Raltegravir. |
|
E.2.2 | Secondary objectives of the trial |
To assess changes in plasma pharmacokinetic parameters of Atazanavir 200mg/12h with regard to his administration as 300/100 mg per day and if the concentrations achieved with this dose are suitable when administered together with Telaprevir 750 mg/8h |
Evaluar los cambios en los parámetros farmacocinéticos plasmáticos de Atazanavir 200 mg/12h respecto a su administración como 300/100 mg día y si las concentraciones alcanzadas con esta pauta son adecuadas cuando se administra junto con Telaprevir 750 mg/8h. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. HIV–HCV co-infected patients over 18 years old under treatment with Pegylated Interferon, Ribavirine and Telaprevir according to the advices of Agencia Española del Medicamento y Productos Sanitarios.
2. Signed informed consent. |
1. Pacientes mayores de 18 años coinfectados por VIH y VHC genotipo 1 en tratamiento con Interferón-α pegilado, Ribavirina y Telaprevir según las recomendaciones de la Agencia Española del Medicamento y Productos Sanitarios.
2. Consentimiento informado del paciente
|
|
E.4 | Principal exclusion criteria |
1. The usual exclusion criteria in clinical practice to start treatment with these drugs (Pegylated interferon, Ribavirine, Telaprevir and Atazanavir) according to national and international recommendations.
2. Concomitant medication or medicinal products that can interfere the pharmacokinetics of Telaprevir or Atazanavir.
3. Medical history of bad absorption or diarrhea (>3 stools) that could alter the absorption of these drugs. |
1. Los criterios de exclusión habituales en la práctica clínica para iniciar tratamiento con estos fármacos (Interferón-α pegilado, Ribavirina, Telaprevir y Atazanavir) según las recomendaciones nacionales e internacionales.
2. Uso concomitante de fármacos o productos medicinales que pudieran alteran la farmacocinética de Telaprevir o Atazanavir.
3. Historia clínica que sugiera malabsorción o presencia de diarrea (>3 deposiciones/día) que pudiera interferir con la absorción de los fármacos en estudio. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To assess changes pharmacokinetic parameters (Cmax, Cmin, AUC0-8, t 12, and Cl) of Telaprevir 750 mg/8h administered with Atazanavir 200 mg/8h not powered. |
Evaluar parámetros farmacocinéticos plasmáticos (Cmax, Cmin, AUC0-8, t1/2, y Cl) de Telaprevir administrado como 750 mg/8h administrado junto con Atazanavir no potenciado (200 mg/12 h). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Blood samples will be taken before Telaprevir and antiretroviral therapy and 1,2,3,4,6,7,8,10 and 12 hours after the dose of Telaprevir and antiretroviral therapy. |
Se obtendrán muestras de sangre inmediatamente antes y tras 1, 2, 3, 4, 6, 7, 8, 10 y 12 horas tras la toma de Telaprevir y terapia antirretroviral. |
|
E.5.2 | Secondary end point(s) |
To assess pharmacokinetic parameters of Atazanavir 200mg/12h with regard to his administration as 300/100 mg per day. |
Evaluar los parámetros farmacocinéticos de Atazanavir administrado como 200 mg/12h respecto a su administración como 300/100 mg/día. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Between 7-10 days after the change of treatment, blood samples will be taken before and after 1, 2, 3, 5, 6, 7, 8, 10, 12 hours after the dose of Telaprevir and Atazanavir. |
Entre 7 y 10 días después del cambio de tratamiento, se tomarán muestras de sangre inmediatamente antes y tras 1, 2, 3, 5, 6, 7, 8, 10, 12 horas tras la toma observada de Telaprevir y de Atazanavir. |
|
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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
|
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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
|
LVLS |
UVUP (ultima visita, último paciente incluido) |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |