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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00909129
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.
Collaborators:
The Swedish Research Council
Hoffmann-La Roche
Information provided by:
Karolinska Institutet
May 15, 2009
May 27, 2009
May 27, 2009
Not Provided
Not Provided
Sustained virological response [ Time Frame: 24 weeks end of treatment (EOT) ]
Same as current
No Changes Posted
T-cell mediated immune responses [ Time Frame: baseline to 24 weeks EOT ]
Same as current
Not Provided
Not Provided
 
Interactions of Hepatitis C Viral (HCV) Dynamics and Immune Activation in HIV Coinfected Patients During HCV Treatment
Hepatitis C Virus Dynamic and Immune Activation in HIV-1 Coinfected Patients Treated With Pegylated Interferon Alfa-2a and Ribavirin
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Human Immunodeficiency Virus
  • Chronic Hepatitis C
  • 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)
Experimental: HIV-1 HCV coinfected patients
HIV-1 HCV coinfected patients undergoing HCV therapy
Interventions:
  • Drug: pegylated interferon-alpha (Pegasys)
  • Drug: ribavirin (COPEGUS)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
Not Provided
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT00909129
03-541
Yes
Not Provided
Not Provided
Annette Alaeus, Karolinska Institutet Sweden
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
Karolinska Institutet
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP