NCT02006745

Open Label Trial of PEG-IFN, RBV & TVR vs. PEG-IFN & RBV Alone in Tx of HCV-1 in HIV-1 Co-infected Patients (CHAT)

Open Label, Randomised, Pilot Trial of Pegylated Interferon, Ribavirin & Telaprevir vs Pegylated Interferon & Ribavirin Alone in Response Guided Treatment of Acute Hepatitis C Genotype 1 Virus Infection in Patients With HIV-1 Co-infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: St Stephens Aids Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to explore the treatment of patients with acute hepatitis C infection (infection acquired within the last 6 months) who are also infected with human immunodeficiency virus (HIV).

Detailed description

In this study, we will compare two treatment options for hepatitis C in patients who also have HIV infection, to see if there are any differences in the numbers of patients treated who successfully got rid of the hepatitis C virus when the treatment was complete. We will also compare how well the two treatment options are tolerated by the patients taking them.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Ribavirin	24 weeks in those achieving RVR (undetectable HCV RNA at 4 weeks) or 48 weeks in those not achieving RVR
DRUG	Telaprevir	12 weeks in those achieving RVR, 24 weeks in those not achieving RVR (HCV RNA \>25 but \<1000 iU/mL at week 4) or 48 weeks in those not achieving RVR (HCV RNA \>1000 iU/mL at week 4).

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2013-12-10
• Last updated: 2017-04-12

Locations

1 site across 1 country: United Kingdom