Interactions of Hepatitis C Viral (HCV) Dynamics and Immune Activation in HIV Coinfected Patients During HCV Treatment

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus; Chronic Hepatitis C
• Interventions: Drug: pegylated interferon-alpha (Pegasys); Drug: ribavirin (COPEGUS)

• Registration Number: NCT00909129
• Lead Sponsor: Karolinska Institutet

Brief Summary

The purpose of this study is to investigate T-cell mediated immune responses to HIV-1 and HCV and determine how these responses are affected by HCV treatment and correlates to response. Furthermore, to study Interferon-inducible protein-10 (IP-10) dynamics during HCV treatment, and correlate this to treatment outcome.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-05
• Study First Submitted: 2009-05-15
• Study First Submitted QC: 2009-05-26
• Last Update Submitted: 2009-05-26
• Study First Posted: 2009-05-27
• Last Update Posted: 2009-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• HIV-1 Hepatitis C coinfected adult patients
• Hepatitis C treatment naive
• Stable HIV-1 infection with or without cART
• > 300 CD4+ cell count

Exclusion Criteria

• Decompensated liver disease
• Ongoing depression
• Ongoing drug abuse
• Other contraindications for interferon or ribavirin treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIV-1 HCV coinfected patients	ribavirin (COPEGUS)	HIV-1 HCV coinfected patients undergoing HCV therapy
HIV-1 HCV coinfected patients	pegylated interferon-alpha (Pegasys)	HIV-1 HCV coinfected patients undergoing HCV therapy

Primary Outcome Measures

Name	Time	Method
Sustained virological response	24 weeks end of treatment (EOT)

Secondary Outcome Measures

Name	Time	Method
T-cell mediated immune responses	baseline to 24 weeks EOT

Trial Locations

Locations (1)

Karolinska University Hospital Solna; 🇸🇪 Stockholm, Sweden