BocepreVIH
Pilot Study to Assess the Efficacy and Safety of Boceprevir, in Combination With Peg-Interferon Alfa and Ribavirin, in Patients With HCV/HIV Co-infection Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin
Sponsor study identifier
interventional
69
1 country
1
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2014
Actual (reported)Study Completion
May 2014
Actual (reported)The majority of Human immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) co-infected patients are non responders after 48 weeks of the current standard-of-care with Peg-Interferon/Ribavirin. The results of re-treatment are disappointing. The addition of Boceprevir to the current standard-of-care has been shown to increase the efficacy of therapy in HCV mono-infected patients previously treated with a bi-therapy. Knowing that HIV/HCV co-infected patients are subject to more rapid hepatic fibrosis as well as to increased risks of cirrhosis, end-stage liver disease and hepatocellular carcinoma, it is important to improve the response rate of the re-treatment of hepatitis C in these patients. The aim of this pilot study is to evaluate the efficacy and safety of Boceprevir in combination with Peg-Interferon alfa 2b plus ribavirin, in patients co-infected with HIV and chronic genotype 1 HCV, and previously treated with Peg-Interferon/Ribavirin. 80 subjects will be enrolled. The primary endpoint will be the Sustained Virologic Response (SVR) defined as undetectable HCV-RNA at Week 24 after the end of therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 25, 2011
Actual (reported)April 14, 2011
Actual (reported)May 2011
Date type not reportedThis date has not been verified as actual or estimated.
May 2014
Actual (reported)May 2014
Actual (reported)Sustained Virologic Response
HCV-RNA measured 24 weeks after the end of the HCV treatment (W72 or W96)
Week 72 or Week 96 (W72 or W96)
HCV viral load
W4, W8, W12, W16, W28, W36 and at treatment completion at W48/72
Predictive factors of Sustained virologic Response (SVR)
Baseline
HIV virologic endpoints
W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48, W60, W72 and W84, W96 if treatment duration is 72 weeks
Residual plasmatic concentration (Cres) of Ribavirin
W4 and W8
Hepatic factors: liver fibrosis score
Screen, W4, W8, W16, W28, W48, W72, W96.
Standard Treatment : * Peg-Interferon (PegIFN) alfa 2b by subcutaneous injection 1,5 µg/kg/week * Ribavirin capsules 200mg: dosage delivered in weight categories (\< 65 kg: 800 mg ; 65-80 kg: 1000 mg; 81-105 kg: 1200mg; \> 105 kg: 1400mg) Three-drug-regimen: * Peg-Interferon alfa 2b by subcutaneous injection 1,5 µg/kg/week * Ribavirin capsules 200mg: dosage delivered in weight categories like in standard treatment * Boceprevir tablets 200mg: 800 mg 3 times a day (2400 mg/j) with food
* Screen period from Week-8 * Standard treatment from day 0 to week 4 (W4) * Three-drug-regimen (Boceprevir introduction) from W4 to W8 * HCV RNA determination at W8 determines treatment group and participation duration: * If undetectable HCV RNA at W8, it is a complete virological response: 3 drug-regimen is continued until W48, then there is a follow-up period up to W72 and SVR analysis, * If HCV RNA ≤ 1000IU/mL at W8, it is an incomplete virological response. The 3-drug-regimen is continued until W72, when another analysis is done.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Boceprevir, Peg-interferon alfa 2b and Ribavirin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordCHU Sainte Marguerite
Marseille, 13009, France
Poizot-Martin I, Bellissant E, Garraffo R, Colson P, Piroth L, Solas C, Renault A, Bourliere M, Halfon P, Ghosn J, Alric L, Naqvi A, Carrieri P, Molina JM; ANRS HC27 BOCEPREVIH Study Group. Addition of boceprevir to PEG-interferon/ribavirin in HIV-HCV-Genotype-1-coinfected, treatment-experienced patients: efficacy, safety, and pharmacokinetics data from the ANRS HC27 study. HIV Clin Trials. 2016 Mar;17(2):63-71. doi: 10.1080/15284336.2015.1135553. Epub 2016 Feb 11.
Isabelle Poizot-Martin, MD
University Hospital, Marseille
Eric Bellissant, MD, PhD
Rennes University Hospital
69 participants (actual enrollment reported by the registry).
First Submitted
March 25, 2011
First Posted
April 14, 2011
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
Rifaximin as a Modulator of Microbial Translocation and Immune Activation
Contact the study team to confirm eligibility.
Primary Completion
May 2014
Actual (reported)Study Completion
May 2014
Actual (reported)Last Updated
October 13, 2014
Record last verified: 2014-10
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Source: ClinicalTrials.gov.
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