HB01EMVIPEG
Pilot Study on Efficacy and Tolerance of Peg-interferon Alpha-2a (Pegasys) Added to Tenofovir DF and Emtricitabine (Truvada) in AGHBe Positive HBV-HIV Co-infected Patients. ANRS HB 01 EMVIPEG.
Sponsor study identifier
Secondary identifiers
interventional
56
1 country
2
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2011
Actual (reported)Study Completion
October 2012
Actual (reported)HBe seroconversion is an important goal for anti-HBV treatment, since it is associated with a non progressive liver infection and a better clinical outcome. However, the rate of HBe seroconversion is low in HIV-HBV co-infected patients, mostly treated by tenofovir and emtricitabine. This study will evaluate the efficacy and the safety of a one-year Peg-interferon alpha 2a additional treatment in patients already treated by tenofovir and emtricitabine without reaching HBe seroconversion.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2012
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 23, 2006
Actual (reported)October 24, 2006
Actual (reported)January 2007
Date type not reportedThis date has not been verified as actual or estimated.
May 2011
Actual (reported)October 2012
Actual (reported)proportion of patients with seroconversion HBe (loose of HBe antigen and acquisition of HBe antibody) and HBV DNA below 2.3 log10 copies per ml
at Week 72
proportion of patients with negative HBe antigen.
at Week 72 and Week 144
proportion of patients with HBV DNA under 2.3 log 10 copies per ml.
at Week 72 and Week 144
proportion of seroconversion HBs.
at Week 72 and Week 144
proportion of patients with no more HBs antigen.
at Week 72 and Week 144
proportion of patients with HBV DNA below 2.3 log 10 copies per ml in relation with 3TC resistance or not before tenofovir treatment; increased of ALT before tenofovir treatment;duration of tenofovir treatment before study.
before tenofovir treatment, duration of tenofovir treatment before study
Week-8 up Week0: HIV antiretroviral therapy Week 0 up Week 48: HIV antiretroviral therapy + TRUVADA + PEGASYS 180μg Week 48 up Week 72: HIV antiretroviral therapy + TRUVADA Week 72 up Week 144: HIV antiretroviral therapy
Truvada ® (200 mg tablet of 300 mg of emtricitabine + tenofovir DF) Dosage 1 tablet taken orally once a day
Pegasys ® injection 180μg Dosage: A subcutaneous injection per week
Service des Maladies Infectieuses CHU
Dijon, 21079, France
Service d'Hépato-Gastroentérologie Hopital Hôtel-Dieu
Lyon, 69288, France
Lionel Piroth, MD
Centre Hospitalier Universitaire Dijon
Fabrice Carrat, MD
Inserm U 707 Paris France
56 participants (actual enrollment reported by the registry).
First Submitted
October 23, 2006
First Posted
October 24, 2006
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Entecavir Intensification for Persistent HBV Viremia in HIV-HBV Infection
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
May 2011
Actual (reported)Study Completion
October 2012
Actual (reported)Last Updated
January 15, 2015
Record last verified: 2015-01
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Source: ClinicalTrials.gov.
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