Interactions of Hepatitis C Viral (HCV) Dynamics and Immune Activation in HIV Coinfected Patients During HCV Treatment (DICO)
This study has been completed.
Sponsor:
Karolinska Institutet
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
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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:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Interferon
Ribavirin
Interferon alfa-2a
Peginterferon Alfa-2a
Hepatitis A Vaccines
U.S. FDA Resources
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)
|
![](https://webarchive.library.unt.edu/web/20130305100143im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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
![](https://webarchive.library.unt.edu/web/20130305100143im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 |
![](https://webarchive.library.unt.edu/web/20130305100143im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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:
Acquired Immunodeficiency Syndrome HIV Infections Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Immunologic Deficiency Syndromes Hepatitis C, Chronic Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |
Immune System Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections Interferon-alpha Interferon Alfa-2a Interferons Ribavirin Peginterferon alfa-2a Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2013