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

NCT ID: NCT00909129

Last Updated: 2009-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Human Immunodeficiency Virus Chronic Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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HIV-1 HCV coinfected patients

HIV-1 HCV coinfected patients undergoing HCV therapy

Group Type EXPERIMENTAL

pegylated interferon-alpha (Pegasys)

Intervention Type DRUG

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

ribavirin (COPEGUS)

Intervention Type DRUG

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

Interventions

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pegylated interferon-alpha (Pegasys)

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

Intervention Type DRUG

ribavirin (COPEGUS)

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

Intervention Type DRUG

Other Intervention Names

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Pegasys (interferon) COPEGUS (RIBAVIRIN)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Karolinska Institutet Sweden

Principal Investigators

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Annette Alaeus, MD;PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Karolinska University Hospital Solna

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type RESULT
PMID: 18495540 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20608766 (View on PubMed)

Other Identifiers

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03-541

Identifier Type: -

Identifier Source: org_study_id

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