Two Different Treatments 24 vs 48 Weeks Chronic Hepatitis C Genotypes 2 and/or 3 in co-Infected HIV-HCV

January 25, 2008 updated by: University of Valencia

Open, Randomized and Multicenter Phase IV Study to Compare the Efficacy and Safety of Two Different Treatments Duration 24 Versus 48 Weeks in Chronic Hepatitis C Genotypes 2 and/or 3 co-Infected HIV-HCV Patients.

The rapidly progression of the disease in HIV-HCV co-infected patients justify the treatment.

Combination of Peg interferon and Ribavirin is the best treatment because it improve the compliance of treatment.

In APRICOT study genotypes 2 and 3 patients received 48 weeks and the rates of end of treatment response was 64% and the sustained virological response (24 weeks after the end of treatment) 62%.

In mono-infected patients trials showed there are not differences in the sustained virological response between 24 and 48 weeks of treatment, however exit the doubt concerning the different kinetic viral in HIV-HCV co-infected patients and this could be related with a lost of profit with a shorter duration of treatment, only 24 weeks.

In this study we woud like to evaluate if 24 weeks of treatment in HIV-HCV co-infected patients genotype 2 or 3 will have the same rate of clearance of virus at the end of follow-up period.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients will randomized to receive 180 µg/weekly of Pef interferon alpha-2a and 800 mg/daily of Ribavirin during 24 weeks or 48 weeks.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 4

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

  • Spain
      • Alicante, Spain, 03010
        • Hospital General de Alicante
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Castellón, Spain, 12004
        • Hospital General de Castellon
      • Granada, Spain, 18013
        • Hospital Clínico San Cecilio
      • Huelva, Spain, 21004
        • Hospital Infanta Elena
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Murcia, Spain, 3003
        • Hospital General de Murcia
      • Málaga, Spain, 29010
        • Hospital Carlos Haya
      • Sevilla, Spain, 41008
        • Hospital Virgen Macarena
      • Valencia, Spain, 46015
        • Hospital Arnau de Vilanova
      • Valencia, Spain, 46009
        • Hospital La Fe
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
    • Alicante
      • Elche, Alicante, Spain, 03202
        • Hospital de Elche
    • Barcelona
      • Badalona, Barcelona, Spain, 08915
        • Hospital Germans Trias i Pujol
    • Cádiz
      • Jerez de la Frontera, Cádiz, Spain, 11009
        • Hospital de Jerez
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36204
        • Hospital Xeral-Cíes
    • Valencia
      • Gandia, Valencia, Spain, 46700
        • Hospital de Gandia

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients of 18-65 years of age
  • Serologic evidence of chronic hepatitis C infection by detectable plasma HCV-RNA
  • Serologic evidence of HIV-1 infection by ELISA and Western-blot
  • Stable status of HIV-1 infection in the opinion of the investigator
  • Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 6 months after treatment end. This may include, but is not limited to, using birth control pills, IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state.
  • Willingness to give written informed consent and willingness to participate to and comply with the study

Exclusion Criteria:

  • Women with ongoing pregnancy or breast feeding
  • IFN or ribavirin therapy at any previous time
  • Any investigational drug <6 weeks prior to the first dose of study drug
  • History or other evidence of a medical condition associated with chronic liver disease other than HCV
  • Hepatocarcinoma observed
  • History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
  • Active HIV-related opportunistic infection and/or malignancy requiring acute systemic therapy
  • Absolute neutrophil count <1500 cells/mm3
  • Hgb <12 g/dL in women or 13 g/dL in men or any patient for whom anemia would be medically problematic
  • Hemoglobinopathy (e.g. thalassemia) or any other cause of or tendency for hemolysis
  • Platelet count <90000 cells/mm3
  • Serum creatinine level >1.5 times the upper limit of normal at screening
  • History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
  • History of a severe seizure disorder or current anticonvulsant use
  • History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
  • History or other evidence of chronic pulmonary disease associated with functional limitation
  • History of significant cardiac disease that could be worsened by acute anemia
  • History of thyroid disease poorly controlled on prescribed medications. Patients with elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease are excluded
  • Evidence of severe retinopathy
  • History of major organ transplantation with an existing functional graft
  • History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
  • History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) <6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
  • Drug use within 6 months of 1st dose and excessive alcohol consumption

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 24 weeks
Drug: Peg interferon + Ribavirin
Peg interferon 180 mcg/weekly Ribavirin 800 mg/daily during 24 weeks
Other Names:
  • Pegasys
Drug: Peg interferon + Ribavirin
Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 48 weeks
Other Names:
  • Pegasys
Active Comparator: 2
Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 48 weeks
Drug: Peg interferon + Ribavirin
Peg interferon 180 mcg/weekly Ribavirin 800 mg/daily during 24 weeks
Other Names:
  • Pegasys
Drug: Peg interferon + Ribavirin
Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 48 weeks
Other Names:
  • Pegasys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
% of patients with RNA-HCV undetectable 24 weeks
Time Frame: 24 weeks after the end of treatment
24 weeks after the end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
% of patients at the end of treatment
Time Frame: 48 weeks of treatmemt
48 weeks of treatmemt

Collaborators and Investigators

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

Sponsor

University of Valencia

Collaborators

Hoffmann-La Roche

Investigators

  • Study Director: Enrique Ortega, Dr, Hospital General Universitario de Valencia

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 Major Dates

Study Start

November 1, 2005

Primary Completion (Anticipated)

April 1, 2008

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

January 25, 2008

First Submitted That Met QC Criteria

January 25, 2008

First Posted (Estimate)

February 11, 2008

Study Record Updates

Last Update Posted (Estimate)

February 11, 2008

Last Update Submitted That Met QC Criteria

January 25, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KHRONOS
  • 2005-000203-34

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.

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