E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute Hepatitis C in HIV co-infection |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
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 determine whether a strategy of triple therapy with pegylated interferon, ribavarin and telaprevir is non-inferior to treatment with pegylated interferon and ribavarin alone in terms of the proportion achieving a sustained virological response. |
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E.2.2 | Secondary objectives of the trial |
To determine whether a response guided strategy of shortened treatment with triple therapy with pegylated interferon and ribavarin plus telaprevir for 12 weeks is non-inferior to treatment for 24 weeks in terms of the proportion of patients achieving a sustained virological response. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Documented current acute hepatitis C genotype 1 infection with detectable HCV-RNA (PCR-assay) with an estimated duration less than 24 weeks as defined below: a. First HCV RNA positive AND b. Prior negative anti-HCV antibody or HCV RNA test within 6 months OR c. rise of liver transaminases above 2.5 x ULN within the past 6 months with prior normal transaminases during the year before AND d. exclusion of other causes of acute hepatitis
2. Confirmed HIV infection
3. Receiving a atazanavir-, etravirine-, rilpivirine-, efavirenz- or raltegravir-based ART regimen or able to switch regimen to these agents with an undetectable HIV viral load for at least 3 months, or not receiving ART with no immediate plans to start ART during the first 6 months of study 4. CD4 T cell count >200/ìl at screening in patients under ART, CD4 T cell count >500/ìl at screening in patients without ART
5. Patients who are 18 years or older
6. Able to give informed consent |
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E.4 | Principal exclusion criteria |
1. HCV infection with non-1 genotype
2. Acute opportunistic infection requiring treatment
3. Malignancy requiring chemotherapy or radiotherapy
4. Active HBV infection (HBs Ag + with positive hepatitis B DNA unless tenofovir containing ART)
5. Known autoimmune disease
6. Hepatic failure
7. History of ischaemic heart disease or other serious cardiac disease
8. Current symptoms of depression, or past history of depression for which the patient is currently taking medication, or history of other serious psychiatric disease
9. Haemoglobinopathy or severe anaemia of any cause
10. Serious abnormality on screening blood tests including, but not limited to: Hemoglobin <8g/dl, absolute neutrophil count <750/mm3, platelets <50000/mm3, creatinine clearance <60ml/min
11. Pregnancy or breast feeding
12. Known hypersensitivity to one of the trial drugs or its excipients
13. Other contraindicated concomitant Treatment
14. Active drug abuse that would make it difficult to comply with the protocol
15. Any other reason why, in the opinion of the investigator, the patient should not be enrolled in the trial. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Sustained virological response (SVR): Negative HCV RNA 24 weeks after end of treatment |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 weeks after end of treatment |
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E.5.2 | Secondary end point(s) |
Negative HCV RNA 12 weeks after end of treatment
Negative HCV RNA at end of treatment (EOT)
Reduction in HCV RNA from baseline to week 4
CD4 count change from baseline to EOT
HIV RNA change from baseline to EOT
Total grade III / IV adverse events by EOT
Adherence to medication |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 4, end of treatment, 12 weeks after end of treatment |
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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 | No |
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) | 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) | 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 | Yes |
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
| 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 | 2 |
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
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The trial will be completed when all patients have been followed up until 24 weeks after the end of treatment. |
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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 | 6 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |