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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by University of Valencia.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University of Valencia
ClinicalTrials.gov Identifier:
NCT00611819
First received: January 25, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Co-Infection HIV-HCV
Drug: Peg interferon + Ribavirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by University of Valencia:

Primary Outcome Measures:
  • % of patients with RNA-HCV undetectable 24 weeks [ Time Frame: 24 weeks after the end of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • % of patients at the end of treatment [ Time Frame: 48 weeks of treatmemt ] [ Designated as safety issue: Yes ]

Enrollment: 59
Study Start Date: November 2005
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Pegasys
Active Comparator: 2
Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 48 weeks
Drug: Peg interferon + Ribavirin
Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 48 weeks
Other Name: Pegasys

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611819

Locations
Spain
Hospital de Elche
Elche, Alicante, Spain, 03202
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08915
Hospital de Jerez
Jerez de la Frontera, Cádiz, Spain, 11009
Hospital Xeral-Cíes
Vigo, Pontevedra, Spain, 36204
Hospital de Gandia
Gandia, Valencia, Spain, 46700
Hospital General de Alicante
Alicante, Spain, 03010
Hospital del Mar
Barcelona, Spain, 08003
Hospital General de Castellón
Castellón, Spain, 12004
Hospital Clínico San Cecilio
Granada, Spain, 18013
Hospital Infanta Elena
Huelva, Spain, 21004
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital la Paz
Madrid, Spain, 28046
Hospital General de Murcia
Murcia, Spain, 3003
Hospital Carlos Haya
Málaga, Spain, 29010
Hospital Virgen Macarena
Sevilla, Spain, 41008
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Hospital la Fe
Valencia, Spain, 46009
Hospital Arnau de Vilanova
Valencia, Spain, 46015
Sponsors and Collaborators
University of Valencia
Hoffmann-La Roche
Investigators
Study Director: Enrique Ortega, Dr Hospital General Universitario de Valencia
  More Information

No publications provided

Responsible Party: Enrique Ortega, Hospital General Universitario of Valencia
ClinicalTrials.gov Identifier: NCT00611819     History of Changes
Other Study ID Numbers: KHRONOS, 2005-000203-34
Study First Received: January 25, 2008
Last Updated: January 25, 2008
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by University of Valencia:
hepatitis
co-infection

Additional relevant MeSH terms:
Infection
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Coinfection
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Parasitic Diseases
Interferons
Ribavirin
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014