Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | September 2011 |
| End Date: | June 2014 |
Safety and Efficacy of 120mg and 240mg BI 201335 Once Daily in Combination With Pegylated Interferon Alpha and Ribavirin for Treatment of Chronic Hepatitis C (HCV) Genotype 1 Infection in HIV/HCV Co-infected Patients. A Multinational, Randomised, Parallel Group, Open-label Trial.
the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12
or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to
re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or
continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV
treatment-naive or relapsers patients coinfected with HIV
or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to
re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or
continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV
treatment-naive or relapsers patients coinfected with HIV
Inclusion criteria:
1. Chronic hepatitis C (HCV) genotype 1 infection
2. Chronic Human Immunodeficiency Virus (HIV) -1 infection
3. HCV treatment naive or HCV treatment experienced but only relapsers
4. Age 18 to 70 years
5. Antiretroviral treatment naive or on stable Highly Active Antiretroviral Therapy
(HAART)
6. Karnofsky score >70
7. HCV viral load >1.000 IU/mL
Exclusion criteria:
1. HCV infection of mixed genotype (1/2, 1/3, 1/4)
2. Evidence of acute or chronic liver due to chronic HCV infection
3. Hepatitis B virus (HBV) infection with presence of HBs-Ag
4. Active malignancy or history or malignancy within the last 5 years
5. Received concomitant systemic antiviral (other than antiretroviral), hematopoietic
growth factor or immunomodulatory treatment in 28 days prior enrolment.
6. Decompensated liver disease,as evidenced by ascites, hepatic encephalopathy,
esophageal variceal bleeding, and/or laboratory values that add up to >/= 7 points
according tho the Child-Turcotte-Pugh classification
7. Hemoglobin
8. Patients with stable cardiac disease and Hemoglobin <12g/dL
9. Known hypersensitivity to any ingredient of the study drugs
We found this trial at
21
sites
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