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

May 26, 2009 updated by: Karolinska Institutet

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, SE-171 77
        • Karolinska University Hospital Solna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Pegasys (interferon)
Drug: ribavirin (COPEGUS)
ribavirin bid 800-1200 mg depending on HCV genotype and body weight
Other Names:
  • COPEGUS (RIBAVIRIN)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sustained virological response
Time Frame: 24 weeks end of treatment (EOT)
24 weeks end of treatment (EOT)

Secondary Outcome Measures

Outcome Measure
Time Frame
T-cell mediated immune responses
Time Frame: baseline to 24 weeks EOT
baseline to 24 weeks EOT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

The Swedish Research Council
Hoffmann-La Roche

Investigators

  • Principal Investigator: Annette Alaeus, MD;PhD, Infectious Diseases Unit, Dept of Medicine Solna, Karolinska Institutet Stockholm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 15, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (Estimate)

May 27, 2009

Study Record Updates

Last Update Posted (Estimate)

May 27, 2009

Last Update Submitted That Met QC Criteria

May 26, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-541

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Hepatitis C

Clinical Trials on pegylated interferon-alpha (Pegasys)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe