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
3 other identifiers
interventional
122
8 countries
29
Brief Summary
The purpose of this study is to collect safety and tolerability data on telaprevir treatment in combination with Peg-IFN-alfa and RBV in patients 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2012
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2011
CompletedFirst Posted
Study publicly available on registry
December 28, 2011
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedAugust 18, 2016
August 1, 2016
2.2 years
December 22, 2011
August 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment-emergent Adverse Events
Protocol-defined adverse events whether serious or non-serious, that occur from the first use of investigational product (telaprevir) to 30 days after administration of the last dose of investigational product (telaprevir) will be part of the analysis.
from first use of the medicinal product to 30 days after administration of the last dose of investigational product (telaprevir)
Study Arms (1)
open label telaprevir
EXPERIMENTALDepending on the patient's HAART regimen, 750 or 1125 mg telaprevir every 8 hours for 12 weeks in combination with pegylated interferon alfa and ribavirin for 48 weeks.
Interventions
type = exact number, unit = mg, number = 750, form = tablet, route = oral use, every 8 hours for 12 weeks in combination with pegylated interferon alfa (Peg-IFN alfa) and ribavirin (RBV) during 48 weeks for eligible non treated HIV patients and for patients whose highly active antiretroviral therapy (HAART) regimen is the combination of ritonavir-boosted atazanavir, plus either TDF or abacavir, plus either emtricitabine or lamivudine, or the combination of raltegravir, plus either TDF or abacavir, plus either emtricitabine or lamivudine, or etravirine, TDF, plus either emtricitabine or lamivudine, or etravirine, abacavir, plus either emtricitabine or lamivudine, or rilpivirine, TDF, plus either emtricitabine or lamivudine, or rilpivirine, abacavir, plus either emtricitabine or lamivudine.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Unknown Facility
Antwerp, Belgium
Unknown Facility
Brussels, Belgium
Unknown Facility
Charleroi, Belgium
Unknown Facility
Ghent, Belgium
Unknown Facility
Leuven, Belgium
Unknown Facility
Liège, Belgium
Unknown Facility
Berlin, Germany
Unknown Facility
Bonn, Germany
Unknown Facility
Cologne, Germany
Unknown Facility
Dortmund, Germany
Unknown Facility
Frankfurt, Germany
Unknown Facility
Hanover, Germany
Unknown Facility
Stuttgart, Germany
Unknown Facility
Tübingen, Germany
Unknown Facility
Budapest, Hungary
Unknown Facility
Dublin, Ireland
Unknown Facility
Luxembourg, Luxembourg
Unknown Facility
Amadora, Portugal
Unknown Facility
Lisbon, Portugal
Unknown Facility
Porto, Portugal
Unknown Facility
Perm, Russia
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Tolyatti, Russia
Unknown Facility
Volgograd, Russia
Unknown Facility
Yoshkar-Ola, Russia
Unknown Facility
Glasgow, United Kingdom
Unknown Facility
Liverpool, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Plymouth, United Kingdom
Related Publications (1)
Gori A, Doroana M, Chernova O, Rockstroh JK, Banhegyi D, Bergin C, Verucchi G, Liu C, DeMasi R, Hadacek B, Nelson M. Telaprevir-based therapy for treatment of HIV-1 and hepatitis C virus co-infected patients: An early access programme. J Infect. 2015 Dec;71(6):675-82. doi: 10.1016/j.jinf.2015.09.013. Epub 2015 Sep 28.
PMID: 26416471DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag International NV, Belgium Clinical Trial
Janssen-Cilag International NV
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2011
First Posted
December 28, 2011
Study Start
June 1, 2012
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
August 18, 2016
Record last verified: 2016-08