Efficacy and Tolerance of Peg-interferon Alpha 2a Added to Tenofovir and Emtricitabine in AgHBe Positive HBV-HIV Co-infected Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by French National Agency for Research on AIDS and Viral Hepatitis.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Gilead Sciences
Roche Pharma AG
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00391638
First received: October 23, 2006
Last updated: February 21, 2012
Last verified: February 2012

October 23, 2006
February 21, 2012
January 2007
May 2011   (final data collection date for primary outcome measure)
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 [ Time Frame: at W 72 ] [ Designated as safety issue: No ]
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 W 72
Complete list of historical versions of study NCT00391638 on ClinicalTrials.gov Archive Site
  • proportion of patients with negative HBe antigen. [ Time Frame: at W 72 ] [ Designated as safety issue: No ]
  • proportion of patients with HBV DNA under 2.3 log 10 copies per ml. [ Time Frame: at W72 ] [ Designated as safety issue: No ]
  • proportion of seroconversion HBs. [ Time Frame: at W72 ] [ Designated as safety issue: No ]
  • proportion of patients with no more HBs antigen. [ Time Frame: at W72 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: before tenofovir treatment, duration of tenofovir treatment before study ] [ Designated as safety issue: No ]
  • Biological evolution and histological of hepatic activity and fibrosis. [ Time Frame: at W 0 and W 72 ] [ Designated as safety issue: No ]
  • Biochemical response (ALT at normal value). [ Time Frame: at W 72 ] [ Designated as safety issue: No ]
  • proportion of patients with :seroconversion HBe and HBV DNA below 2.3 log 10 copies per ml [ Time Frame: at W 48 ] [ Designated as safety issue: No ]
  • HBV and HIV resistance mutations to tenofovir DF and Emtricitabine. [ Time Frame: at W 72 ] [ Designated as safety issue: No ]
  • Immunological and virological evolution of HIV infection. [ Time Frame: between W 0 and W 144 ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: between W 0 and W 144 ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: W 0, W12, W24, W48, W72 ] [ Designated as safety issue: No ]
  • proportion of patients with negative HBe antigen at W 72.
  • proportion of patients with HBV DNA under 2.3 log 10 copies per ml at W72.
  • proportion of seroconversion HBs at W72.
  • proportion of patients with no more HBs antigen at W72.
  • 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.
  • Biological evolution and histological of hepatic activity and fibrosis.
  • Biochemical response at W 72 (ALT at normal value).
  • proportion of patients with :seroconversion HBe and HBV DNA below 2.3 log 10 copies per ml at W48
  • HBV and HIV resistance mutations to tenofovir DF and Emtricitabine.
  • Immunological and virological evolution of HIV infection.
  • Safety
  • Quality of life
Not Provided
Not Provided
 
Efficacy and Tolerance of Peg-interferon Alpha 2a Added to Tenofovir and Emtricitabine in AgHBe Positive HBV-HIV Co-infected Patients
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.

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.

Many HBV-HIV co-infected patients are currently treated with dual activity drugs such as tenofovir and emtricitabine, often in combination. However, despite the potent antiviral activity of these drugs, the rate of HBe seroconversion is quite low, and not always sustained over time. 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. On the other hand, treatments with antiviral and immuno-modulator activity such as Peg-interferon, are infrequently used in co-infected patients, despite promising data in the field of HBV mono-infection with increased rates and sustained HBe seroconversions. This pilot study will evaluate the efficacy and the safety of a one-year Peg-interferon alpha 2a additional treatment (180 micro-g once a week, by injection), in 55 patients already treated by tenofovir and emtricitabine for at least 6 months, and who did not reached HBe seroconversion

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis B
  • HIV Infections
  • Drug: TRUVADA (EMTRICITABINE + TENOFOVIR DF)
    Truvada ® (200 mg tablet of 300 mg of emtricitabine + tenofovir DF) Dosage 1 tablet taken orally once a day
  • Biological: PEGASYS 180μg (Interféron pégylé alpha -2a)
    Pegasys ® injection 180μg Dosage: A subcutaneous injection per week
Experimental: HIV antiretroviral therapy, TRUVADA , PEGASYS 180μg
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
Interventions:
  • Drug: TRUVADA (EMTRICITABINE + TENOFOVIR DF)
  • Biological: PEGASYS 180μg (Interféron pégylé alpha -2a)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
56
October 2012
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV infection
  • Karnofsky above 80 per cent
  • Stable ARV since 4 months
  • CD4 above 200 per mm3
  • ARN VIH below 10000 copies per ml
  • hepatitis B chronic with : positive antigenaemia HBe and negative antiHBe, positive DNA HBV before or under tenofovir treatment, DNA HBV negative or below 10000 copies per ml at W-8.
  • Previous treatment by tenofovir and lamivudine or emtricitabine more than 6 months

Exclusion Criteria:

  • HIV 2 infection
  • Hepatitis C or D
  • Opportunistic infection
  • Alcool consummation more than 50g/d
  • Cirrhosis
  • Pregnancy or plan of pregnancy
  • Breastfeeding
  • Immunosuppressive or modulating of the immune response treatment
  • Other Hepatitis B treatments than tenofovir, lamivudine or emtricitabine since 6 months
  • Malabsorption
  • Exclusive HIV therapy with Truvada
  • Evolutive cancer under chemotherapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00391638
2006-004137-15, ANRS HB 01 EMVIPEG
Yes
French National Agency for Research on AIDS and Viral Hepatitis
French National Agency for Research on AIDS and Viral Hepatitis
  • Gilead Sciences
  • Roche Pharma AG
Principal Investigator: Lionel Piroth, MD CHU Dijon France
Study Chair: Fabrice Carrat, MD Inserm U 707 Paris France
French National Agency for Research on AIDS and Viral Hepatitis
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP