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

25. januar 2008 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

59

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 1
Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 24 weeks
Legemiddel: Peg interferon + Ribavirin
Peg interferon 180 mcg/weekly Ribavirin 800 mg/daily during 24 weeks
Andre navn:
  • Pegasys
Legemiddel: Peg interferon + Ribavirin
Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 48 weeks
Andre navn:
  • Pegasys
Aktiv komparator: 2
Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 48 weeks
Legemiddel: Peg interferon + Ribavirin
Peg interferon 180 mcg/weekly Ribavirin 800 mg/daily during 24 weeks
Andre navn:
  • Pegasys
Legemiddel: Peg interferon + Ribavirin
Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 48 weeks
Andre navn:
  • Pegasys

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
% of patients with RNA-HCV undetectable 24 weeks
Tidsramme: 24 weeks after the end of treatment
24 weeks after the end of treatment

Sekundære resultatmål

Resultatmål
Tidsramme
% of patients at the end of treatment
Tidsramme: 48 weeks of treatmemt
48 weeks of treatmemt

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Valencia

Samarbeidspartnere

Hoffmann-La Roche

Etterforskere

  • Studieleder: Enrique Ortega, Dr, Hospital General Universitario de Valencia

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2005

Primær fullføring (Forventet)

1. april 2008

Studiet fullført (Forventet)

1. desember 2008

Datoer for studieregistrering

Først innsendt

25. januar 2008

Først innsendt som oppfylte QC-kriteriene

25. januar 2008

Først lagt ut (Anslag)

11. februar 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. februar 2008

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. januar 2008

Sist bekreftet

1. januar 2008

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KHRONOS
  • 2005-000203-34

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