E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic hepatitis C infection |
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E.1.1.1 | Medical condition in easily understood language |
Chronic hepatitis C infection |
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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 | 20.0 |
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 | 100000004848 |
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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 |
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 study medication. |
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E.2.2 | Secondary objectives of the trial |
Reference is made to section 2.1 (p.33 - 34) of the Clinical Trial Protocol. |
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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 |
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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. |
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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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks after the last planned dose of study drug |
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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
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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
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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 | 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 | 7 |
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 |
Australia |
Brazil |
France |
Poland |
Russian Federation |
Spain |
Sweden |
United Kingdom |
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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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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 |