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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)

Primary Purpose

Hepatitis B, HIV Infections

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
TRUVADA (EMTRICITABINE + TENOFOVIR DF)
PEGASYS 180μg (Interféron pégylé alpha -2a)
Sponsored by
French National Agency for Research on AIDS and Viral Hepatitis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B focused on measuring HIV and Hepatitis B coinfection, Peg interferon, tenofovir, emtricitabine, Hepatitis B e Antigens, Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service des Maladies Infectieuses CHU
  • Service d'Hépato-Gastroentérologie Hopital Hôtel-Dieu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIV antiretroviral therapy, TRUVADA , PEGASYS 180μg

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

proportion of patients with negative HBe antigen.
proportion of patients with HBV DNA under 2.3 log 10 copies per ml.
proportion of seroconversion HBs.
proportion of patients with no more HBs antigen.
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 (ALT at normal value).
proportion of patients with :seroconversion HBe and HBV DNA below 2.3 log 10 copies per ml
HBV and HIV resistance mutations to tenofovir DF and Emtricitabine.
Immunological and virological evolution of HIV infection.
Safety
Quality of life
Treatment adherence

Full Information

First Posted
October 23, 2006
Last Updated
January 14, 2015
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Gilead Sciences, Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT00391638
Brief Title
Efficacy and Tolerance of Peg-interferon Alpha 2a Added to Tenofovir and Emtricitabine in AgHBe Positive HBV-HIV Co-infected Patients
Acronym
HB01EMVIPEG
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 Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Gilead Sciences, Roche Pharma AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, HIV Infections
Keywords
HIV and Hepatitis B coinfection, Peg interferon, tenofovir, emtricitabine, Hepatitis B e Antigens, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIV antiretroviral therapy, TRUVADA , PEGASYS 180μg
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
TRUVADA (EMTRICITABINE + TENOFOVIR DF)
Intervention Description
Truvada ® (200 mg tablet of 300 mg of emtricitabine + tenofovir DF) Dosage 1 tablet taken orally once a day
Intervention Type
Biological
Intervention Name(s)
PEGASYS 180μg (Interféron pégylé alpha -2a)
Intervention Description
Pegasys ® injection 180μg Dosage: A subcutaneous injection per week
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
proportion of patients with negative HBe antigen.
Time Frame
at Week 72 and Week 144
Title
proportion of patients with HBV DNA under 2.3 log 10 copies per ml.
Time Frame
at Week 72 and Week 144
Title
proportion of seroconversion HBs.
Time Frame
at Week 72 and Week 144
Title
proportion of patients with no more HBs antigen.
Time Frame
at Week 72 and Week 144
Title
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
Title
Biological evolution and histological of hepatic activity and fibrosis.
Time Frame
at day 0 and Week 72
Title
Biochemical response (ALT at normal value).
Time Frame
at Week 72 and Week 144
Title
proportion of patients with :seroconversion HBe and HBV DNA below 2.3 log 10 copies per ml
Time Frame
at Week 48
Title
HBV and HIV resistance mutations to tenofovir DF and Emtricitabine.
Time Frame
at Week 72
Title
Immunological and virological evolution of HIV infection.
Time Frame
between Day 0 and Week 144
Title
Safety
Time Frame
between Day 0 and Week 144
Title
Quality of life
Time Frame
Day 0, Week 12, Week 24, Week 48, Week 72
Title
Treatment adherence
Time Frame
Day 0 to Week 144

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lionel Piroth, MD
Organizational Affiliation
Centre Hospitalier Universitaire Dijon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fabrice Carrat, MD
Organizational Affiliation
Inserm U 707 Paris France
Official's Role
Study Chair
Facility Information:
Facility Name
Service des Maladies Infectieuses CHU
City
Dijon cedex
ZIP/Postal Code
21079
Country
France
Facility Name
Service d'Hépato-Gastroentérologie Hopital Hôtel-Dieu
City
Lyon Cedex 02
ZIP/Postal Code
69288
Country
France

12. IPD Sharing Statement

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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

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