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

Primary Purpose

Human Immunodeficiency Virus, Chronic Hepatitis C

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

pegylated interferon-alpha (Pegasys)

ribavirin (COPEGUS)

About this trial

This is an interventional basic science trial for Human Immunodeficiency Virus focused on measuring HIV-1, Chronic hepatitis C, Immune activation, HCV kinetics, IP-10

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Karolinska University Hospital Solna

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIV-1 HCV coinfected patients

Arm Description

HIV-1 HCV coinfected patients undergoing HCV therapy

Outcomes

Primary Outcome Measures

Sustained virological response

Secondary Outcome Measures

T-cell mediated immune responses

Full Information

NCT ID

NCT00909129

First Posted

May 15, 2009

Last Updated

May 26, 2009

Sponsor

Karolinska Institutet

Collaborators

The Swedish Research Council, Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00909129

Brief Title

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

Acronym

DICO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2009

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Karolinska Institutet

Collaborators

The Swedish Research Council, Hoffmann-La Roche

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Human Immunodeficiency Virus, Chronic Hepatitis C

Keywords

HIV-1, Chronic hepatitis C, Immune activation, HCV kinetics, IP-10

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HIV-1 HCV coinfected patients

Arm Type

Experimental

Arm Description

HIV-1 HCV coinfected patients undergoing HCV therapy

Intervention Type

Drug

Intervention Name(s)

pegylated interferon-alpha (Pegasys)

Other Intervention Name(s)

Pegasys (interferon)

Intervention Description

Pegylated interferon-alpha 2a 180 micrograms s.c. weekly

Intervention Type

Drug

Intervention Name(s)

ribavirin (COPEGUS)

Other Intervention Name(s)

COPEGUS (RIBAVIRIN)

Intervention Description

ribavirin bid 800-1200 mg depending on HCV genotype and body weight

Primary Outcome Measure Information:

Title

Sustained virological response

Time Frame

24 weeks end of treatment (EOT)

Secondary Outcome Measure Information:

Title

T-cell mediated immune responses

Time Frame

baseline to 24 weeks EOT

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Annette Alaeus, MD;PhD

Organizational Affiliation

Infectious Diseases Unit, Dept of Medicine Solna, Karolinska Institutet Stockholm

Official's Role

Principal Investigator

Facility Information:

Facility Name

Karolinska University Hospital Solna

City

Stockholm

ZIP/Postal Code

SE-171 77

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

18495540

Citation

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.

Results Reference

result

PubMed Identifier

20608766

Citation

Falconer 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.

Results Reference

derived

Learn more about this trial

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

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