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NCT00909129 Clinical Trial

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

Chronic Hepatitis C Clinical Trial

— DICO  

Official title:
Hepatitis C Virus Dynamic and Immune Activation in HIV-1 Coinfected Patients Treated With Pegylated Interferon Alfa-2a and Ribavirin

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00909129
Other study ID # 03-541
Secondary ID
Status Completed
Phase N/A
First received May 15, 2009
Last updated May 26, 2009

Study information
Verified date May 2009
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• pegylated interferon-alpha (Pegasys)
Pegylated interferon-alpha 2a 180 micrograms s.c. weekly
• ribavirin (COPEGUS)
ribavirin bid 800-1200 mg depending on HCV genotype and body weight

Locations
Country Name City State
Sweden Karolinska University Hospital Solna Stockholm

Sponsors (3)
Lead Sponsor Collaborator
Karolinska Institutet Hoffmann-La Roche, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Gonzalez VD, Falconer K, Michaëlsson J, Moll M, Reichard O, Alaeus A, Sandberg JK. Expansion of CD56- NK cells in chronic HCV/HIV-1 co-infection: reversion by antiviral treatment with pegylated IFNalpha and ribavirin. Clin Immunol. 2008 Jul;128(1):46-56. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Sustained virological response 24 weeks end of treatment (EOT) No
Secondary T-cell mediated immune responses baseline to 24 weeks EOT No
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