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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: May 27, 2009
Last Update Posted: May 27, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
The Swedish Research Council
Hoffmann-La Roche
Information provided by:
Karolinska Institutet
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: None (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) ]

Secondary Outcome Measures:
  • T-cell mediated immune responses [ Time Frame: baseline to 24 weeks EOT ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909129

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

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
First Submitted: May 15, 2009
First Posted: May 27, 2009
Last Update Posted: May 27, 2009
Last Verified: May 2009

Keywords provided by Karolinska Institutet:
Chronic hepatitis C
Immune activation
HCV kinetics

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Immunologic Deficiency Syndromes
Hepatitis C, Chronic
Acquired Immunodeficiency Syndrome
HIV Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents