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

This study has been completed.
Sponsor:
Collaborators:
The Swedish Research Council
Hoffmann-La Roche
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00909129
First received: May 15, 2009
Last updated: May 26, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention
Human Immunodeficiency Virus
Chronic Hepatitis C
Drug: pegylated interferon-alpha (Pegasys)
Drug: ribavirin (COPEGUS)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Hepatitis C Virus Dynamic and Immune Activation in HIV-1 Coinfected Patients Treated With Pegylated Interferon Alfa-2a and Ribavirin

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Sustained virological response [ Time Frame: 24 weeks end of treatment (EOT) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • T-cell mediated immune responses [ Time Frame: baseline to 24 weeks EOT ] [ Designated as safety issue: No ]

Enrollment: 25
Arms Assigned Interventions
Experimental: HIV-1 HCV coinfected patients
HIV-1 HCV coinfected patients undergoing HCV therapy
Drug: pegylated interferon-alpha (Pegasys)
Pegylated interferon-alpha 2a 180 micrograms s.c. weekly
Other Name: Pegasys (interferon)
Drug: ribavirin (COPEGUS)
ribavirin bid 800-1200 mg depending on HCV genotype and body weight
Other Name: COPEGUS (RIBAVIRIN)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909129

Locations
Sweden
Karolinska University Hospital Solna
Stockholm, Sweden, SE-171 77
Sponsors and Collaborators
Karolinska Institutet
The Swedish Research Council
Hoffmann-La Roche
Investigators
Principal Investigator: Annette Alaeus, MD;PhD Infectious Diseases Unit, Dept of Medicine Solna, Karolinska Institutet Stockholm
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Annette Alaeus, Karolinska Institutet Sweden
ClinicalTrials.gov Identifier: NCT00909129     History of Changes
Other Study ID Numbers: 03-541
Study First Received: May 15, 2009
Last Updated: May 26, 2009
Health Authority: Sweden: Medical Products Agency

Keywords provided by Karolinska Institutet:
HIV-1
Chronic hepatitis C
Immune activation
HCV kinetics
IP-10

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Ribavirin
Interferons
Interferon-alpha
Peginterferon alfa-2a
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents

ClinicalTrials.gov processed this record on September 16, 2014