E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute Hepatitis C in HIV infected patients |
|
E.1.1.1 | Medical condition in easily understood language |
Acute Hepatitis C in HIV infected patients |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To document that a 8-week treatment of acute HCV with grazoprevir
(MK-5172), elbasvir (MK-8742) is effective. |
|
E.2.2 | Secondary objectives of the trial |
To document that treatment of acute HCV with grazoprevir (MK-5172),
elbasvir (MK-8742) is safe |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. HIV positive
2. Acute HCV genotype 1 or 4 infection (≤26 weeks old at the baseline
visit) according to definition mentioned above |
|
E.4 | Principal exclusion criteria |
1. Not on cART and a CD4 <500 at the time of screening
2. Patients on cART for >6 months with a HIV viral load >400 copies
3. Disallowed co-medication that cannot be stopped or replaced:
Therefore ALL co-medication, including over-the-counter drugs should
be checked for potential drug-drug interactions using the investigators
brochure (appendix A). In particular, care should be taken for patients
that are taking >10mg atorvastatin or >5mg rosuvastatin per day and
the dose should be reduced to the lowest dose available (10mg for
atorvastatin and 5 for rosuvastatin). Alternatively a switch to
pravastatin may be preferred. When in doubt about drug-drug
interactions, contact the coordinating investigator.
4. History of liver cirrhosis of any etiology. Inclusion of patients with a
chronic well-controlled HBV (HBV-DNA <below the limit of detection) is
allowed if fibroscan excludes >F1 fibrosis. Fibroscan reports <5 years
old can be used for screening.
5. Protease inhibitor based and NNRTI based cART regimens are not
allowed. Therefore, the inability to switch to a HAART regimen consisting
of 2 nucleoside/tide reverse transcriptase inhibitors and an allowed
third agent which can be raltegravir (Isentress®) 400mg BID,
dolutegravir (Tivicay) 50mg QD or rilpivirine 25mg QD. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
SVR 12 weeks after the end of all therapy in the ITT population |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1. SVR12 in all genotype 1 infected patients in the mITT.
2. SVR12 in genotype 4 infected patients (ITT and mITT)
3. SVR12 in all patients included (=genotype 1 and 4, ITT and mITT)
4. SVR12 in RVR2 and RVR4 (mITT)
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5. SVR12 in all patients (=genotype 1+4) according to IL28 genotype
(*)
6. SVR24 (mITT and ITT)(%)
7. Cost-effectivity of treatment during the acute phase of HCV in
comparison with treatment 12 months later for chronic HCV or treatment
only at a certain level of liver fibrosis. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
12 or 24 weeks after end of therapy |
|
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 | No |
E.6.5 | Efficacy | No |
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) | 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 | 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) | 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
| 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 | 2 |
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
|
end of trial is last patient visit at week 24 after the end of treatment. |
het einde van de studie is als de laatste patient 24 weken na het staken van behandeling op de visit komt. |
|
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |