Interactions of Hepatitis C Viral (HCV) Dynamics and Immune Activation in HIV Coinfected Patients During HCV Treatment
DICO
Hepatitis C Virus Dynamic and Immune Activation in HIV-1 Coinfected Patients Treated With Pegylated Interferon Alfa-2a and Ribavirin
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2009
CompletedFirst Posted
Study publicly available on registry
May 27, 2009
CompletedMay 27, 2009
May 1, 2009
May 15, 2009
May 26, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sustained virological response
24 weeks end of treatment (EOT)
Secondary Outcomes (1)
T-cell mediated immune responses
baseline to 24 weeks EOT
Study Arms (1)
HIV-1 HCV coinfected patients
EXPERIMENTALHIV-1 HCV coinfected patients undergoing HCV therapy
Interventions
Pegylated interferon-alpha 2a 180 micrograms s.c. weekly
ribavirin bid 800-1200 mg depending on HCV genotype and body weight
Eligibility Criteria
You may qualify if:
- HIV-1 Hepatitis C coinfected adult patients
- Hepatitis C treatment naive
- Stable HIV-1 infection with or without cART
- \> 300 CD4+ cell count
You may not qualify if:
- Decompensated liver disease
- Ongoing depression
- Ongoing drug abuse
- Other contraindications for interferon or ribavirin treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- The Swedish Research Councilcollaborator
- Hoffmann-La Rochecollaborator
Study Sites (1)
Karolinska University Hospital Solna
Stockholm, SE-171 77, Sweden
Related Publications (2)
Gonzalez VD, Falconer K, Michaelsson 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. doi: 10.1016/j.clim.2008.03.521. Epub 2008 May 20.
PMID: 18495540RESULTFalconer K, Askarieh G, Weis N, Hellstrand K, Alaeus A, Lagging M. IP-10 predicts the first phase decline of HCV RNA and overall viral response to therapy in patients co-infected with chronic hepatitis C virus infection and HIV. Scand J Infect Dis. 2010 Dec;42(11-12):896-901. doi: 10.3109/00365548.2010.498019. Epub 2010 Jul 7.
PMID: 20608766DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Annette Alaeus, MD;PhD
Infectious Diseases Unit, Dept of Medicine Solna, Karolinska Institutet Stockholm
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 15, 2009
First Posted
May 27, 2009
Last Updated
May 27, 2009
Record last verified: 2009-05