- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01925183
Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C (HIVCOBOC-RGT)
Response-guided Triple-therapy Using Boceprevir in Combination With PEGIFN/RBV in HIV/HCV-coinfected Patients
Response-guided triple-therapy with boceprevir (BOC) in combination with pegylated interferon (PEGIFN) and ribavirin (RBV) is the current standard of care for HIV-negative patients infected with hepatitis C genotype (HCV-GT) 1. In contrast, in HIV-positive patients, a fixed treatment duration of 48 weeks is used.
The aim of this study is to assess efficacy and safety of response-guided triple-therapy with BOC in combination with PEGIFN and RBV in HIV-positive patients. Thus, treatment duration will be individualized based on HCV-RNA negativity at treatment week 8 (W8). All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at W8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks, while patients with detectable HCV-RNA at W8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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Vienna, Østerrike, 1090
- Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Confirmed HIV infection (anti-HIV1/2 antibody positive).
- Chronic HCV infection (anti-HCV positive, HCV-RNA detectable for >6 months).
- HCV-GT 1 infection.
- Age ≥18 years and ≤65 years.
- No prior treatment with BOC/PEGIFN/RBV.
- CD4+ cell count >200 cells/µL.
- Stable antiretroviral therapy (ART) including tenofovir/emtricitabine (Truvada®, Gilead) and raltegravir (Isentress®, MSD) with HIV-RNA <50 copies/mL.
- Valid result on transient elastography or liver biopsy within 6 months prior to enrollment.
- Female patients of childbearing potential must agree to use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
- Male patients or their female partners must agree to use an effective contraceptive during treatment and for 7 months after treatment has been concluded.
Exclusion Criteria:
- HCV-GT other than HCV-GT 1.
- Cirrhotic patients (as defined by METAVIR F4 in liver biopsy or liver stiffness >12.3 kPa) with decompensated liver disease (Child-Pugh stage B/C).
- Chronic liver diseases other than hepatitis C virus infection (hepatitis B virus infection: HBsAg positivity, nonalcoholic steatohepatitis, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, cystic fibrosis).
- Significant cardiac disease (ejection fraction <40% at echocardiography).
- Significant pulmonary disease (COPD stage GOLD III/IV).
- Significant renal disease (serum creatinine >1.5 mg/dL).
- Subjects taking medication(s) that is/are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events such as but not limited to, orally administered midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, and ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine).
- Contraindications for boceprevir (Victrelis®, MSD), pegylated interferon alpha-2a (Pegasys®, Roche) or ribavirin (Copegus®, Roche), as listed in section 4.3 of the respective summary of product characteristics (SmPCs).
- Ongoing alcohol abuse (average daily alcohol consumption >50g).
- Ongoing illicit drug abuse.
- Unwillingness to give written informed consent.
- Pregnancy and breastfeeding.
- Women wishing to become pregnant.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 28 weeks of treatment duration
All patients will receive 4 weeks of PEGIFN/RBV lead-in.
Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.
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180mcg once weekly; subcutaneous injection
Andre navn:
600mg two times daily (BID) (e.g.
3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally
Andre navn:
800mg three times daily (TID) (e.g.
4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
Andre navn:
|
Eksperimentell: 48 weeks of treatment duration
All patients will receive 4 weeks of PEGIFN/RBV lead-in.
Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks
|
180mcg once weekly; subcutaneous injection
Andre navn:
600mg two times daily (BID) (e.g.
3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally
Andre navn:
800mg three times daily (TID) (e.g.
4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Proportion of Subjects With Sustained Virologic Response (SVR12)
Tidsramme: Follow-up week 12 (FU12)
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Defined as HCV-RNA negativity by a sensitive assay
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Follow-up week 12 (FU12)
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Proportions of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Baseline (BL) to Follow-up week 12 (FU12)
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Baseline (BL) to Follow-up week 12 (FU12)
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Markus Peck-Radosavljevic, MD, Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Leversykdommer
- Flaviviridae-infeksjoner
- Hepatitt, viral, menneskelig
- Enterovirusinfeksjoner
- Picornaviridae-infeksjoner
- Hepatitt, kronisk
- Hepatitt
- Hepatitt A-virus
- Hepatitt C
- Hepatitt C, kronisk
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Antimetabolitter
- Antineoplastiske midler
- Immunologiske faktorer
- Interferoner
- Interferon-alfa
- Ribavirin
- Peginterferon alfa-2a
- Interferon alfa-2
Andre studie-ID-numre
- HIVCOBOC-RGT
- 2012-005591-33 (EudraCT-nummer)
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. .
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