Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected With Both HIV and Hepatitis C Virus (HCV)

28. oktober 2021 oppdatert av: National Institute of Allergy and Infectious Diseases (NIAID)

A Prospective, Multicenter, Phase II/III, Open-Label, Controlled, Randomized Trial Evaluating the Efficacy, Safety, and Tolerability of Interferon-alfa-2a Plus Ribavirin Versus PEG-interferon-alfa-2a Plus Ribavirin for Chronic Hepatitis C Virus (HCV) Infection in Individuals Co-Infected With Human Immunodeficiency Virus-1 (HIV-1)

The purpose of this study is to see if treatment with PEG-interferon-alfa-2a (PEG-IFN) plus ribavirin is a more effective treatment for hepatitis C virus (HCV) than interferon-alfa-2a (IFN) plus ribavirin for patients infected with both HCV and HIV. The study will also compare the 2 regimens to see which has fewer side effects.

HCV infection is common in patients infected with HIV. Patients infected with both HIV and HCV viruses seem to have more severe hepatitis C. A combination of IFN and ribavirin has been shown to lessen the severity of HCV. PEG-IFN is a modified form of IFN that stays in the blood longer, which means that patients would not have to take the treatment as often. This study will compare the safety and effectiveness of PEG-IFN to IFN when each is combined with ribavirin.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Infection with HCV is common in patients infected with HIV owing to similar routes of transmission. The cellular immunosuppression caused by HIV infection appears to lead to an increased HCV plasma load, more progressive liver disease, and, in patients with chronic hepatitis C, increased mortality. Ribavirin treatment combined with IFN has shown improved sustained virologic response rates over IFN monotherapy. PEG-IFN, a chemically modified formulation of IFN, circulates for a much longer time in the blood than the parent compound. Pharmacokinetic and pharmacodynamic data suggest that PEG-IFN injected weekly would have the potential for superior efficacy as compared with IFN injected 3 times per week. The efficacy and safety profiles of combination therapy with PEG-IFN and ribavirin are not well known. This study will compare combination therapy consisting of PEG-IFN and ribavirin with that of IFN and ribavirin.

Patients are stratified according to HCV genotype and CD4 count and viral load, then randomized to either Arm A (IFN plus ribavirin) or Arm B (PEG-IFN plus ribavirin). Patients receive up to 48 weeks of treatment. Virologic response is assessed at Week 24 and a decision to continue or discontinue treatment is made. If a virologic response is shown at Week 24, the patient continues treatment for an additional 24 weeks. If no virologic response is observed, then the histologic response is assessed by a liver biopsy. If biopsy shows a histologic response is present, treatment is continued for 24 weeks. If biopsy shows no histologic response, treatment is discontinued. [AS PER AMENDMENT 07/20/01: Patients with virologic response who discontinue after Week 24 will have liver biopsy at time of discontinuation. Patients with no virologic response continuing study treatment after having a liver biopsy within 2 weeks of Week 24, who also demonstrate histologic response and decide to discontinue after Week 24, are strongly encouraged to have a 2nd liver biopsy at the end of treatment. Patients with no virologic response who discontinue after Week 24 will not have liver biopsy at time of discontinuation.] Physical examinations are done regularly and blood samples collected for routine laboratory tests, confidential genetic testing, and to measure HCV and HIV-1 plasma viral loads. Women able to become pregnant have regular pregnancy tests. All patients are followed for an additional 24 weeks after treatment discontinuation.

Patients may enroll in 1 or none of the following substudies: A5091s, Hepatic C Viral Kinetics in Subjects Co-infected with Human Immunodeficiency Virus-1 (HIV-1) and Hepatitis C Virus Genotype 1 (HCV-1); [AS PER AMENDMENT 07/20/01: The following text has been deleted: or A5092s, Evaluation of the Effects of Ribavirin on Zidovudine (ZDV) or Stavudine (d4T) Triphosphate Formation] [AS PER AMENDMENT 07/20/01: Substudy A5092s, Evaluation of the Effects of Ribavirin on Zidovudine (ZDV) or Stavudine (d4T) Triphosphate Formation is now a stand-alone study.]

Studietype

Intervensjonell

Registrering

132

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • California
      • San Diego, California, Forente stater, 92103
        • Ucsd, Avrc Crs
      • San Francisco, California, Forente stater, 941104206
        • Ucsf Aids Crs
    • Colorado
      • Aurora, Colorado, Forente stater, 80262
        • University of Colorado Hospital CRS
    • Florida
      • Miami, Florida, Forente stater, 331361013
        • Univ. of Miami AIDS CRS
    • Georgia
      • Atlanta, Georgia, Forente stater, 30308
        • The Ponce de Leon Ctr. CRS
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96816
        • Univ. of Hawaii at Manoa, Leahi Hosp.
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202
        • Methodist Hosp. of Indiana
      • Indianapolis, Indiana, Forente stater, 46202
        • Indiana Univ. School of Medicine, Wishard Memorial
      • Indianapolis, Indiana, Forente stater, 462025250
        • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
    • Iowa
      • Iowa City, Iowa, Forente stater, 52242
        • Univ. of Iowa Healthcare, Div. of Infectious Diseases
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Massachusetts General Hospital ACTG CRS
      • Boston, Massachusetts, Forente stater, 02118
        • Bmc Actg Crs
      • Boston, Massachusetts, Forente stater, 02215
        • Beth Israel Deaconess Med. Ctr., ACTG CRS
      • Boston, Massachusetts, Forente stater, 02215
        • Brigham and Women's Hosp. ACTG CRS
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
        • University of Minnesota, ACTU
    • New York
      • New York, New York, Forente stater, 10003
        • Beth Israel Med. Ctr., ACTU
      • New York, New York, Forente stater, 10016
        • NY Univ. HIV/AIDS CRS
      • New York, New York, Forente stater, 10029
        • Mt. Sinai Med. Ctr. A0404 CRS
      • New York, New York, Forente stater
        • HIV Prevention & Treatment CRS
      • Rochester, New York, Forente stater, 14642
        • Univ. of Rochester ACTG CRS
      • Rochester, New York, Forente stater, 14642
        • AIDS Care CRS
    • Ohio
      • Cincinnati, Ohio, Forente stater, 452670405
        • Univ. of Cincinnati CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Philadelphia Veterans Admin. Med. Ctr. A6205 CRS
    • Texas
      • Dallas, Texas, Forente stater, 75390
        • Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic

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

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Have chronic liver disease consistent with chronic hepatitis C.
  • Have evidence of hepatitis C within the 48 weeks prior to entry.
  • Are 18 to 65 years old.
  • Agree to use 2 barrier methods of birth control during the study and for 6 months after stopping the medications.
  • Meet 1 of the following sets of guidelines: 1) have a CD4 count of more than 100 cells/mm3 and have a viral load (level of HIV in the blood) of less than 10,000 copies/ml within 35 days prior to study entry, and have taken stable anti-HIV drugs for at least 12 weeks prior to study entry and plan to remain on the same treatment for the first 24 weeks of the study; or 2) have a CD4 count of more than 300 cells/mm3 within 35 days prior to study entry and have not taken any anti-HIV drugs in the 12 weeks prior to entry, and do not plan to start anti-HIV treatment within the first 24 weeks of study entry.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have a positive test for hepatitis B.
  • Show evidence of medical conditions associated with long-term liver disease other than HCV.
  • Have severe mental illness, especially depression, or have been hospitalized for mental illness within the previous 24 weeks.
  • Are allergic to any of the study products.
  • Have uncontrolled seizures.
  • Have had or currently have any immune diseases.
  • Have lung disease such that function is limited.
  • Have had evidence of heart disease or certain heart problems within 24 weeks of study entry.
  • Have severe retinopathy (eye disease).
  • Have had a major organ transplant and still have the graft.
  • Have any other severe disease or cancer that would interfere with the study.
  • Have had anti-cancer or immune-regulating drugs or radiation treatment within 24 weeks of study entry or expect to need such treatment during the study.
  • Have received rifampin, rifabutin, pyrazinamide, isoniazid, ganciclovir, hydroxyurea, granulocyte colony-stimulating factor (G-CSF), or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 6 weeks of study entry.
  • Abuse drugs or alcohol. Patients in methadone programs may participate.
  • Have a blood disorder such as thalassemia.
  • Have received interferon or oral ribavirin therapy.
  • Have taken an experimental drug that affects HCV, within 6 weeks of study entry.
  • Need to use during the study any of the drugs prohibited by the study.
  • Have had an opportunistic (AIDS-related) infection within 4 weeks of study entry.
  • Are pregnant or breast-feeding.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling

Samarbeidspartnere og etterforskere

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Etterforskere

  • Studiestol: Raymond Chung, MD, Harvard/Massachusetts General Hospital
  • Studiestol: Paul Volberding, MD, San Francisco General Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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 2000

Studiet fullført

1. august 2006

Datoer for studieregistrering

Først innsendt

9. januar 2001

Først innsendt som oppfylte QC-kriteriene

30. august 2001

Først lagt ut (Anslag)

31. august 2001

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. november 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. oktober 2021

Sist bekreftet

1. oktober 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A5071
  • 10675 (Annen identifikator: CTEP)
  • Substudy AACTG A5091s
  • ACTG A5071
  • AACTG A5071

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere