Telaprevir Open-Label Study in Co-Infected Patients

Multicenter, Open-Label Study of Telaprevir in Combination With Peginterferon Alfa and Ribavirin in Human Immunodeficiency Virus/Genotype 1 Chronic Hepatitis C Coinfected Subjects With Severe Fibrosis or Compensated Cirrhosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003593-85-BE

Enrollment

1000

Registered

2011-12-08

Start date

2012-04-26

Completion date

Unknown

Last updated

2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis C infection MedDRA version: 14.1 Level: LLT Classification code 10019752 Term: Hepatitis C virus (HCV) System Organ Class: 10022891 - Investigations

Interventions

Trade Name: INCIVO Product Name: INCIVO Pharmaceutical Form: Film-coated tablet INN or Proposed INN: telaprevir CAS Number: 402957-28-2 Current Sponsor code: VX-950, TVR Other descriptive name: TELAPR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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. OR Not on a HAART regimen and not expected to start HIV treatment during the study, ie, have CD4 count of =500 cells/mm3 and a HIV-1 and/or HIV-2 viral load =50,000 copies/mL at screening - If on stable permissible HAART regimen, have CD4 count =200 cells/mm3 or =15% and HIV-1 and/or HIV-2 viral load =65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: - Is eligible for enrollment into an ongoing clinical study of telaprevir - Is infected or coinfected with HCV of another genotype than genotype 1 - Has a 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 the respective local prescribing information - Have any contraindication to the currently prescribed HAART regimen at screening. Note: Patients who have a contraindication to a nonprescribed permissible HAART medication are not excluded. - Positive human leukocyte antigen (HLA)-B5701 genotyping result at screening (or documented result prior to screening) if abacavir is a component of HAART

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this open-label safety study is to collect safety and tolerability data on telaprevir treatment in combination with Peg-IFN-alfa 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: ;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)	—

Measure

Time frame

Main Objective: The objective of this open-label safety study is to collect safety and tolerability data on telaprevir treatment in combination with Peg-IFN-alfa 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: ;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

Measure	Time frame
Secondary end point(s): NAP;Timepoint(s) of evaluation of this end point: NAP	—

Countries

Austria, Belgium, Germany, Hungary, Ireland, Italy, Luxembourg, Portugal, Russian Federation, Spain, Switzerland, United Kingdom

Contacts

Public ContactJanssen Biologics BV

Janssen-Cilag International NV - Clinical Registry Group

ClinicalTrialsEU@its.jnj.com+31071524 21 66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026