Telaprevir Open-Label Study in Co-Infected Patients
- Conditions
- Chronic Hepatitis C infectionMedDRA version: 14.1Level: LLTClassification code 10047457Term: Viral hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-003593-85-IT
- Lead Sponsor
- JANSSEN-CILAG INTERNATIONAL N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1000
Be a man or woman, between 18 and 70 years of age, inclusive,Have diagnosis of HIV-1 or HIV-2 infection, or HIV-1 and HIV-2 coinfection for more than 6 months before the screening visit. Should have been on a stable permissible HAART regimen for more than 8 weeks before Day 1 without switches. If on stable permissible HAART regimen, have CD4 count =200 cells/mm3 or =15% and HIV-1 and/or HIV-2 viral load <50 copies/mL for at least 6 months before starting treatment is recommended Have evidence of HCV infection genotype 1. Have a quantifiable plasma HCV RNA Have documentation of severe fibrosis (Metavir F3 or Ishak 3-4) or cirrhosis (Metavir F4 or Ishak 5 6) assessed by liver biopsy or non-invasive test (eg, fibrotest, fibroscan)within 18 months before screening. Have compensated liver disease (Child-Pugh Grade A clinical classification) Have access to the hepatitis C treatments Peg-IFN-alfa and RBV Have laboratory values (assessed at local laboratory) that meet the following or adhere to local prescribing information or standard of care:•Absolute neutrophil count (ANC) =1,500 cells/mm3;•Platelet count =90,000 cells/mm3,•Hemoglobin concentration =12 g/dL in females or =13 g/dL in males •Calculated creatinine clearance =70 mL/min;•Potassium =3.5 mmol/L If a women of childbearing potential, must have a negative serum ? human chorionic gonadotropin (? hCG) or urine pregnancy test documented at the screening visit and a negative serum or urine pregnancy test before the first dose of study drug to ensure that they are not pregnant at the time of starting treatment.If heterosexually active, a female subject of childbearing potential and a nonvasectomized male subject who has a female partner of childbearing potential must agree to use 2 effective contraceptives from screening onwards until 4 months (female subject) or 7 months (male subject) after RBV therapy has ended. To be eligible for this early access program, subjects should agree to use 2 effective non-hormonal methods of contraception during combination therapy and for 2 months after the last intake of telaprevir; 13. Sign the informed consent document indicating that they understand the purpose of and procedures required for the early access program and are willing to participate in the early access program14.Sign the informed consent form for pharmacogenomic research in order to participate in the optional pharmacogenomic component of this early access program (where local regulations permit). Refusal to give consent for this component does not exclude a subject from participation in the EAP
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 980
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
Eligible for enrollment into an ongoing clinical study of telaprevir. Infected or coinfected with HCV of another genotype than genotype 1.Contraindication to the administration of Peg-IFN-alfa or RBV, or medical history or laboratory values that preclude treatment with Peg-IFN-alfa or RBV according to RCP.Contraindication to the currently prescribed HAART regimen at screening. Note: Subjects with contraindication to a nonprescribed permissible HAART medication are not excluded.Positive HLA-B5701 genotyping result at screening if abacavir is a component of HAART.Planned treatment holiday for HAART regimen.History of having received investigational HCV protease or polymerase inhibitors.Signs or symptoms of HCC.Serum alpha-fetoprotein (AFP) level and ultrasonography should be available at screening.History of decompensated liver disease.Coinfection with active hepatitis B.Inadequately controlled thyroid function.Baseline increased risk for anemia.Congenital QT prolongation or family history of congenital QT prolongation or sudden death. History of severe psychiatric disease. History of immunologically mediated disease. Any systemic antineoplastic or immunomodulatory (eg, systemic corticosteroids) treatment or radiation within 24 weeks before Day 1 or the expectation that such treatment will be needed at any time during the early access program.Presence of acute or active conditions of HIV (clinical grades 3 or 4 within 6 months before start of treatment.Stage C opportunistic infection occurring within the 6 months before start of treatment.Clinical evidence of chronic pulmonary disease associated with functional impairment.History of uncontrolled severe seizure disorders.History or other evidence of a clinically relevant ophthalmologic disorder due to diabetes mellitus or hypertension or history or other evidence of severe retinopathy.History of major organ transplantation with an existing functional graft with the exception of corneal transplants and skin grafts.Currently enrolled in an investigational drug study or has participated in such a study within 30 days before Day 1.Woman who is pregnant or breast-feeding. Any condition (including, but not limited to, alcohol and drug use), which, in the opinion of the investigator, could compromise the subject’s safety or adherence to the early access program.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this open-label safety study is to collect safety and tolerability data on telaprevir treatment in combination with Peg-IFNalfa and RBV in subjects with HIV/genotype 1 chronic HCV coinfection with severe fibrosis or compensated cirrhosis who are not eligible for enrollment into an ongoing clinical study of telaprevir.;Secondary Objective: NAP;Primary end point(s): Treatment-emergent adverse events;Timepoint(s) of evaluation of this end point: from first use of the medicinal product to 30 days after administration of the last dose of investigational product (telaprevir)
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: NAP