Telaprevir in HIV-HCV Coinfected Patients Who Had Previously Failed a Peginterferon-Ribavirin Regimen
TelapreVIH
Pilot Study of PegInterferon-Ribavirin-Telaprevir Efficacy and Tolerability in HIV-HCV Coinfected Patients Who Had Previously Failed a PegInterferon-Ribavirin Regimen. (ANRS HC26 TelapreVIH)
2 other identifiers
interventional
70
1 country
1
Brief Summary
This phase II, multicentric, national pilot trial is designed to estimate the sustained virological response rate (SVR) following a 12 weeks treatment by telaprevir combined with a 48 or 72 weeks treatment by peginterferon and ribavirin, based upon the rapid virological response (RVR) at week 8 (4 weeks after telaprevir start), and to compare the observed SVR to 20%, a rate determining a significant therapeutic benefit in this population of patients. The primary endpoint will be the SVR defined as undetectable HCV-RNA measured 24 weeks after the end of therapy (EOT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2011
1 active site
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
March 28, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedFirst Posted
Study publicly available on registry
April 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedApril 2, 2026
April 1, 2026
2.4 years
March 28, 2011
April 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Estimation of SVR following a 12 wks treatment by telaprevir combined with a 48 or 72 wks peginterferon-ribavirin treatment, based upon the rapid virological response, and comparison to 20% (which would correspond to a significant therapeutic benefit)
HCV-RNA measured 24 weeks after the end of HCV treatment
up to 92 weeks or 116 weeks depending on rapid virologic response
Secondary Outcomes (2)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
From week 0 up to 92 weeks or 116 weeks depending on rapid virologic response
Estimation of the Sustained Virological Response defined as undetectable HCV-RNA at Week 12 after the end of HCV treatment
at Week 60 or Week 84 depending on rapid virologic response
Study Arms (1)
Telaprevir-pegIFN alfa-2a-ribavirine
EXPERIMENTALSingle Group Assignment
Interventions
Drug : telaprevir, Tablet, Oral, 750 mg, q8h, 12 weeks if associated with atazanavir or raltegravir Drug : telaprevir, Tablet, Oral, 1125 mg, q8h, 12 weeks if associated with efavirenz
Subcutaneous injection, 180 μg, once weekly, 48 weeks or 72 weeks
(weight-based dose) Tablet, Oral, 1000 mg for subjects weighing below 75 kg or 1200 mg for subjects weighing equal or over75 kg, once daily, 48 weeks or 72 weeks
Eligibility Criteria
You may qualify if:
- Informed consent form signed at screening visit at the latest
- Patient registered with or covered by a social security scheme
- HIV-1 infection
- Chronic, genotype 1, hepatitis C with detectable HCV RNA at screening
- Virological failure following a previous treatment of at least 12 weeks by peginterferon alpha-2a ≥ 135 µg once weekly or peginterferon alpha-2b ≥ 1.0 µg per kg once weekly + ribavirin ≥ 600 mg once daily. Virological failure defined by persistence of a detectable HCV-RNA, with the same genotype than before. Null responder patient, with less than 2 Log10 HCV-RNA decline at week 12 with cirrhosis are excluded from the study. Null responder patients without cirrhosis (equal or below METAVIR F3) are limited to less than 30 % of all patients included
- No Interferon and/or Ribavirin within past 6 months
- Stable antiretroviral treatment for over 3 months at screening. Authorized combinations: tenofovir-emtricitabine-boosted atazanavir,tenofovir-emtricitabine-efavirenz,tenofovir-emtricitabine-raltegravir, once Drug-Drug interaction data will be available. Patients with a stable combination of at least 3 of the following drugs: tenofovir, emtricitabine/lamivudine, efavirenz, atazanavir-boosted or not, raltegravir. These patients cannot participate in the pharmacokinetic study
- CD4 \>200/mm3 and \>15% at screening
- Plasma HIV-RNA \<50 copies/mL for at least 6 months at screening visit
- Body weight ≥ 40 kg to equal or below 125 kg
- Fibrosis stage have to be documented by a significant liver biopsy (cumulative length ≥ 15 mm or ≥ 6 portal spaces), within 3 years. Patients with a previous liver biopsy exhibiting cirrhosis lesions (METAVIR F4) are allowed to enter the study without a new biopsy. The proportion of patients with cirrhosis lesions (METAVIR F4) is limited to 50% of all patients.
- Male patients, female patients with child-bearing potency and their heterosexual partners must use an adequate contraception from 1 month before initiation of treatment to 7 months following the end of treatment for men and to 4 months following the end of treatment for women. Subjects (or their female partners) must not be pregnant or planning to become pregnant within 2 years after enrolling in the study
You may not qualify if:
- Patient with liver failure (Child B and C) or past history of decompensated cirrhosis
- Significant oesophageal varices (Stages 2-3) on a gastrointestinal endoscopy within 3 years
- Detectable AgHBs
- HIV-2 co-infection
- Contra-indication to ribavirin or peginterferon
- Severe pre-existing cardiac or pulmonary disease
- Untreated dysthyroidism
- Uncontrolled Type 2 diabetes
- Optic neuritis past history and retinal condition
- History of organ transplant
- Severe hemoglobinopathy
- Congenital QT prolongation, family history of congenital QT prolongation or sudden unexpected death
- Contra-indication to telaprevir, hypersensitivity to any component of the drug product
- Any disease requiring long term, systemic corticotherapy or immunosuppressive therapy during study
- Alcohol intake that may represent an obstacle for the participation of the subject
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen-Cilag Ltd.collaborator
- ANRS, Emerging Infectious Diseaseslead
Study Sites (1)
Service Maladies Infectieuses et Tropicales, Hôpital de la Croix-Rousse
Lyon, France
Related Publications (1)
Cotte L, Braun J, Lascoux-Combe C, Vincent C, Valantin MA, Sogni P, Lacombe K, Neau D, Aumaitre H, Batisse D, de Truchis P, Gervais A, Michelet C, Morlat P, Vittecoq D, Rosa I, Bertucci I, Chevaliez S, Aboulker JP, Molina JM; French National Agency for Research on AIDS and Viral Hepatitis (ANRS) HC26 Study Group. Telaprevir for HIV/hepatitis C virus-coinfected patients failing treatment with pegylated interferon/ribavirin (ANRS HC26 TelapreVIH): an open-label, single-arm, phase 2 trial. Clin Infect Dis. 2014 Dec 15;59(12):1768-76. doi: 10.1093/cid/ciu659. Epub 2014 Aug 18.
PMID: 25139963DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent COTTE, MD
Hopital Croix Rousse LYON FRANCE
- STUDY CHAIR
Jean-Pierre ABOULKER, MD
INSERM SC10 VILLEJUIF FRANCE
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2011
First Posted
April 11, 2011
Study Start
April 1, 2011
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
April 2, 2026
Record last verified: 2026-04