Telaprevir in HIV-HCV Coinfected Patients Who Had Previously Failed a Peginterferon-Ribavirin Regimen (TelapreVIH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01332955|
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : January 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C, Chronic HIV Infection||Drug: Telaprevir Biological: pegIFN alfa-2a Drug: Ribavirin||Phase 2|
This phase II pilot trial is designed for HIV-1 and HCV genotype 1 coinfected patients who had previously failed a peginterferon-ribavirin regimen.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||April 2011|
|Primary Completion Date :||September 2013|
|Study Completion Date :||September 2013|
Experimental: Telaprevir-pegIFN alfa-2a-ribavirine
Single Group Assignment
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
Other Name: VX-950Biological: pegIFN alfa-2a
Subcutaneous injection, 180 μg, once weekly, 48 weeks or 72 weeks
Other Name: peginterferon alfa-2a, Pegasys®Drug: Ribavirin
(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
- 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 ]HCV-RNA measured 24 weeks after the end of HCV treatment
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 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 [ Time Frame: at Week 60 or Week 84 depending on rapid virologic response ]HCV-RNA measured 12 weeks after the end of HCV treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332955
|Service Maladies Infectieuses et Tropicales, Hôpital de la Croix-Rousse|
|Principal Investigator:||Laurent COTTE, MD||Hopital Croix Rousse LYON FRANCE|
|Study Chair:||Jean-Pierre ABOULKER, MD||INSERM SC10 VILLEJUIF FRANCE|