E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C / HIV-1 co-infection |
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E.1.1.1 | Medical condition in easily understood language |
Chronic Hepatitis C / HIV-1 co-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 | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10008912 |
E.1.2 | Term | Chronic hepatitis C |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 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. |
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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 |
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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; |
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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/μL (<1200 cells/ μL for blacks), platelet count < 90,000 cells/μL, hemoglobin < 11 g/dL for females, hemoglobin < 12 g/dL for males;
•Total bilirubin ≥ 34 μmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilbert’s disease or antiretroviral regimen contains atazanavir. |
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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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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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. |
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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 |
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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 | 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 |
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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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 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 |
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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 | 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 |