An open label, randomised, non-inferiority trial of pegylated interferon, ribavirin and telaprevir versus pegylated interferon and ribavirin alone in the response guided treatment of acute hepatitis C genotype 1 virus infection in patients with HIV-1 co-infection: The CHAT Study

Phase 1

• Conditions: Acute Hepatitis C in HIV co-infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-001419-21-DE
• Lead Sponsor: niversitätsklinikum Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-09
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 40

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified