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Hepatitis C, ChronicPhase 2TelapreVIHNCT01332955

Telaprevir in HIV-HCV Coinfected Patients Who Had Previously Failed a Peginterferon-Ribavirin Regimen

A Phase 2 study testing Telaprevir, pegIFN alfa-2a and Ribavirin in people with Hepatitis C, Chronic and HIV Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic, HIV Infection
What is being tested?
Telaprevir, pegIFN alfa-2a and Ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteFrance
Study dates
Apr 2011to Sep 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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
  • Substance abuse that may represent an obstacle for the participation of the subject
  • Acute CDC stage C opportunistic infection within the previous 6 months
  • Past history of cancer within the previous 5 years (except skin basal cell carcinoma, Kaposi's disease in stable remission, in situ cervical cancer and in situ anal cancer)
  • Any active malignant disease including hepatocellular carcinoma
  • Patients unable to observe the study procedures
  • Participation to another clinical trial within the previous 30 days
  • Haemoglobin <120 g/L for women and <130 g/L for men
  • Platelets <90 000/mm3
  • Neutrophils <1 500/mm3
  • Renal insufficiency defined by an estimated Glomerular Filtration Rate < 60 mL/mn (MDRD equation)
  • Associated medication susceptible to interfere with the pharmacokinetic parameters of telaprevir and/or antiretroviral associated drugs

Trial locations and contacts

1 site in 1 country.

France1 site

  • Service Maladies Infectieuses et Tropicales, Hôpital de la Croix-Rousse

    Lyon

Other trials in France

About this study

Official title: 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)

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).

Read the detailed description

This phase II pilot trial is designed for HIV-1 and HCV genotype 1 coinfected patients who had previously failed a peginterferon-ribavirin regimen.

Intervention Design:

  • Induction, Lead-in, phase: day 0 to week 4 PegInterferon alpha-2a, 180 µg subcutaneous injection, once weekly + Ribavirin (weight-based dose) 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d.
  • Telaprevir phase: week 4 to week 16 PegInterferon alpha-2a, 180 µg subcutaneous injection, once weekly + Ribavirin (weight-based dose) 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d. + Telaprevir 750 mg q 8h (or 1125 mg q 8h in association with Efavirenz)
  • Maintenance phase: week 16 to week 48 or 72 PegInterferon alpha-2a, 180 µg subcutaneous injection, once weekly + Ribavirin (weight-based dose) 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d.

The duration of the maintenance phase is determined by the RVR at week 8 (4 weeks after Telaprevir start.

Complete RVR (not measurable HCV-RNA at week 8): maintenance from week 16 to week 48

_Partial RVR (HCV-RNA below 1 000 UI/mL but still measurable at week 8): maintenance phase from week 16 to week 48

And stable antiretroviral treatment for over 3 months among the authorized combinations: (tenofovir 300 mg, emtricitabine 200 mg, atazanavir 300 mg, ritonavir 100 mg) q.d. or (tenofovir 300 mg, emtricitabine 200 mg, efavirenz 600 mg) q.d. or (tenofovir 300 mg, emtricitabine 200 mg q.d. and raltegravir 400 mg b.i.d.) once Drug-Drug interaction data will be available. Patients who could not receive one of these 3 combinations can be included if they are receiving a stable combination of at least 3 drugs among the following: tenofovir, emtricitabine/lamivudine, efavirenz, atazanavir-boosted or not, raltegravir (once Drug-Drug interaction data will be available). These patients cannot participate in the pharmacokinetic study.

The trial will enroll 80 subjects. The proportion of patients included, presenting with cirrhosis (METAVIR F4) will remain below 50% of all patients The proportion of patients included, null-responders to previous HCV treatment (HCV-RNA decline at week 12 less than 2 log10 UI/ml) but no cirrhosis (maximum equal METAVIR F3) will remain below 30% of patients.

Being tested
Telaprevir, pegIFN alfa-2a, Ribavirin
Keywords
Hepatitis C, Chronic, HIV Infection, Telaprevir, Peginterferon alfa-2a, Ribavirin, Pharmacokinetic, Pharmacogenetic, Previous peginterferon-ribavirin regimen failure
Medical subject headings
Hepatitis C, Chronic, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelaprevirDrug

    Also called VX-950

    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

  • pegIFN alfa-2aBiological

    Also called peginterferon alfa-2a, Pegasys®

    Subcutaneous injection, 180 μg, once weekly, 48 weeks or 72 weeks

  • RibavirinDrug

    Also called Copegus®, Rebetol®

    (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

Study groups in NCT01332955
Study groupRoleWhat they receive
Telaprevir-pegIFN alfa-2a-ribavirineExperimentalSingle Group Assignment
Receives: Drug: Telaprevir; Biological: pegIFN alfa-2a; Drug: Ribavirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 92 weeks or 116 weeks depending on rapid virologic response

Secondary outcomes (2)

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Measured: From week 0 up to 92 weeks or 116 weeks depending on rapid virologic response

  2. Estimation of the Sustained Virological Response defined as undetectable HCV-RNA at Week 12 after the end of HCV treatment

    HCV-RNA measured 12 weeks after the end of HCV treatment

    Measured: at Week 60 or Week 84 depending on rapid virologic response

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionSep 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01332955
Sponsor's protocol ID
ANRS HC26 TelapreVIH
Other IDs
2010-023287-41
Acronym
TelapreVIH
Status last verified
Apr 2026
First submitted
28 Mar 2011
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25139963

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telaprevir, pegIFN alfa-2a and Ribavirin in people with Hepatitis C, Chronic and HIV Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: up to 92 weeks or 116 weeks depending on rapid virologic response). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01332955, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

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