E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic hepatitis C infection |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic hepatitis C infection |
|
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 | 16.1 |
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 | 100000004848 |
|
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 |
The primary objective is to assess the antiviral efficacy of telaprevir, Peg-IFN-alfa-2a, and RBV in HCV-1/HIV-1 coinfected subjects as measured by sustained virologic response (SVR12planned). SVR12planned is defined as having an undetectable HCV RNA level 12 weeks after the last planned dose of HCV study medication. |
|
E.2.2 | Secondary objectives of the trial |
Reference is made to section 2.1 (p.33 - 34) of the Clinical Trial Protocol. |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
- A substudy of VX-950HPC3008 to evaluate the intensive steady-state pharmacokinetic profile of telaprevir and selected antiretrovirals - final - dated 31 October 2011
Objective: The objective of this substudy is to obtain intensive steady-state PK profiles of telaprevir and selected HIV ARVs in plasma.
- A darunavir substudy of VX-950HPC3008 to evaluate the steady-state pharmacokinetics of telaprevir and darunavir, the short-term HCV RNA response, maintenance of HIV virologic control, and safety in HCV/HIV coinfected subjects adding telaprevir plus pegylated-interferon-alfa- 2a/ribavirin to a darunavir/ritonavir-based regimen - final - dated 05 April 2012
Objectives: The primary objective of this substudy is to obtain the intensive steady-state PK profiles of telaprevir, DRV, and ritonavir in plasma, and to characterize the subject’s total and unbound
(free) concentrations of telaprevir and DRV.
The secondary objective of this substudy is to evaluate HCV ribonucleic acid (RNA) responses, maintenance of HIV virologic control, and safety during the first 12 weeks of study treatment. |
|
E.3 | Principal inclusion criteria |
- HCV RNA more than 6 months prior screening or histological diagnosis based on liver biopsy or fibroscan) HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL.
- Confirmed diagnosis of HIV-1 infection >6 months before the screening visit.
- CD4 count >300 cells/mm3 at screening and no value <200 cells/mm3 within 6 months of screening visit.
- HIV-1 RNA undetectable by an ultrasensitive assay at least once within 90 days of the screening visit.
- No HIV RNA values >200 copies/mL within 6 months of the screening visit.
- HIV-1 RNA <50 copies/mL by Roche Taqman HIV-1 RNA v2 at screening. |
|
E.4 | Principal exclusion criteria |
- Anticipated need to switch HAART regimens from screening through the Telaprevir treatment period
- Infection or co-infection with HCV other than genotype 1
- Contraindication to the administration of Peg-IFN-alfa or RBV
- Hepatitis B virus (HBV) co-infection
- Acute or active condition of HIV-associated opportunistic infection within 6 months of screening
- Pre-existing psychiatric condition
- Evidence of hepatic decompensation. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks after the last planned dose of study drug |
|
E.5.2 | Secondary end point(s) |
- Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels
- Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels
- Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels
- Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels
- Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels
- Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels
- Proportion of patients having confirmed detectable HCV ribonucleic acid (RNA levels)
- Proportion of patients having an increase > 1 log in HCV RNA level from the lowest level reached, or a value of HCV RNA > 100 IU/mL in subjects whose HCV RNA has previously become < 25 IU/mL during treatment
- Evaluate safety and tolerability of telaprevir in combination with Peg-IFN-alfa-2a and RBV and permitted HIV ARVs as assessed by AEs
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- 24 weeks after last planned dose of study drug
- week 4 of study drug
- week 12 of study drug
- week 4 and week 12 of study drug
- actual end of study drug (week 24, week 48 or early discontinuation)
- planned end of study drug (week 24 or week 48)
- follow-up period after previous undetectable HCV RNA levels at actual end of study drugs (week 24 or 48 or early discontinuation)
- from day 1 till week 24 or 48
- from time signed and dated ICF until follow-up visit 4 weeks after intake last medication
|
|
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 | No |
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 | 22 |
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 |
France |
Sweden |
Australia |
Brazil |
Spain |
Poland |
Russian Federation |
United Kingdom |
|
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
|
|
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 | 1 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |