Acute Hepatitis C in HIV co-infection
Conditions
Interventions
Trade Name: Incivo
Product Name: Telaprevir
Product Code: EMEA/H/C/002313
Pharmaceutical Form: Tablet
INN or Proposed INN: Telaprevir
CAS Number: 402957-28-2
Current Sponsor code: TPV
Other descriptiv
Sponsors
Universitätsklinikum Bonn
Eligibility
Sex/Gender
Male
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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.;Primary end point(s): Sustained virological response (SVR): Negative HCV RNA 24 weeks after end of treatment;Timepoint(s) of evaluation of this end point: 24 weeks after end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;Timepoint(s) of evaluation of this end point: Week 4, end of treatment, 12 weeks after end of treatment | — |
Countries
Germany
Contacts
Public ContactChristoph Boesecke
Universitätsklinikum Bonn
Outcome results
None listed