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

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. Identifier: NCT00909129
Recruitment Status : Completed
First Posted : May 27, 2009
Last Update Posted : May 27, 2009
The Swedish Research Council
Hoffmann-La Roche
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Chronic Hepatitis C Drug: pegylated interferon-alpha (Pegasys) Drug: ribavirin (COPEGUS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
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 the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Sustained virological response [ Time Frame: 24 weeks end of treatment (EOT) ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00909129

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Karolinska University Hospital Solna
Stockholm, Sweden, SE-171 77
Sponsors and Collaborators
Karolinska Institutet
The Swedish Research Council
Hoffmann-La Roche
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Principal Investigator: Annette Alaeus, MD;PhD Infectious Diseases Unit, Dept of Medicine Solna, Karolinska Institutet Stockholm
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Annette Alaeus, Karolinska Institutet Sweden Identifier: NCT00909129    
Other Study ID Numbers: 03-541
First Posted: May 27, 2009    Key Record Dates
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:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Immunologic Deficiency Syndromes
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