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Efficacy and Tolerance of Peg-interferon Alpha 2a Added to Tenofovir and Emtricitabine in AgHBe Positive HBV-HIV Co-infected Patients (HB01EMVIPEG)

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ClinicalTrials.gov Identifier: NCT00391638
Recruitment Status : Completed
First Posted : October 24, 2006
Last Update Posted : January 15, 2015
Sponsor:
Collaborators:
Gilead Sciences
Roche Pharma AG
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis B HIV Infections Drug: TRUVADA (EMTRICITABINE + TENOFOVIR DF) Biological: PEGASYS 180μg (Interféron pégylé alpha -2a) Phase 2 Phase 3

Detailed Description:
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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : January 2007
Actual Primary Completion Date : May 2011
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Week 72 ]

Secondary Outcome Measures :
  1. proportion of patients with negative HBe antigen. [ Time Frame: at Week 72 and Week 144 ]
  2. proportion of patients with HBV DNA under 2.3 log 10 copies per ml. [ Time Frame: at Week 72 and Week 144 ]
  3. proportion of seroconversion HBs. [ Time Frame: at Week 72 and Week 144 ]
  4. proportion of patients with no more HBs antigen. [ Time Frame: at Week 72 and Week 144 ]
  5. 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 ]
  6. Biological evolution and histological of hepatic activity and fibrosis. [ Time Frame: at day 0 and Week 72 ]
  7. Biochemical response (ALT at normal value). [ Time Frame: at Week 72 and Week 144 ]
  8. proportion of patients with :seroconversion HBe and HBV DNA below 2.3 log 10 copies per ml [ Time Frame: at Week 48 ]
  9. HBV and HIV resistance mutations to tenofovir DF and Emtricitabine. [ Time Frame: at Week 72 ]
  10. Immunological and virological evolution of HIV infection. [ Time Frame: between Day 0 and Week 144 ]
  11. Safety [ Time Frame: between Day 0 and Week 144 ]
  12. Quality of life [ Time Frame: Day 0, Week 12, Week 24, Week 48, Week 72 ]
  13. Treatment adherence [ Time Frame: Day 0 to Week 144 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT00391638


Locations
France
Service des Maladies Infectieuses CHU
Dijon cedex, France, 21079
Service d'Hépato-Gastroentérologie Hopital Hôtel-Dieu
Lyon Cedex 02, France, 69288
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Gilead Sciences
Roche Pharma AG
Investigators
Principal Investigator: Lionel Piroth, MD Centre Hospitalier Universitaire Dijon
Study Chair: Fabrice Carrat, MD Inserm U 707 Paris France
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT00391638     History of Changes
Other Study ID Numbers: 2006-004137-15
ANRS HB 01 EMVIPEG
First Posted: October 24, 2006    Key Record Dates
Last Update Posted: January 15, 2015
Last Verified: January 2015

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis ):
HIV and Hepatitis B coinfection
Peg interferon
tenofovir
 emtricitabine
Hepatitis B e Antigens
Treatment Experienced

Additional relevant MeSH terms:
Hepatitis
HIV Infections
Hepatitis B
Liver Diseases
Digestive System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hepadnaviridae Infections
DNA Virus Infections
 Hepatitis, Viral, Human
Interferons
Tenofovir
Interferon-alpha
Emtricitabine
Peginterferon alfa-2a
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents