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Clinical Trials/NCT00391638
NCT00391638CompletedPhase 2

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.

French National Agency for Research on AIDS and Viral Hepatitis2 sites in 1 country56 target enrollmentStarted: January 2007Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
56
Locations
2
Primary Endpoint
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

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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-
  • 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

Arms & Interventions

HIV antiretroviral therapy, TRUVADA , PEGASYS 180μg

Experimental

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: TRUVADA (EMTRICITABINE + TENOFOVIR DF) (Drug)

HIV antiretroviral therapy, TRUVADA , PEGASYS 180μg

Experimental

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: PEGASYS 180μg (Interféron pégylé alpha -2a) (Biological)

Outcomes

Primary Outcomes

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 Outcomes

  • Immunological and virological evolution of HIV infection.(between Day 0 and Week 144)
  • Safety(between Day 0 and Week 144)
  • proportion of patients with negative HBe antigen.(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)
  • Quality of life(Day 0, Week 12, Week 24, Week 48, Week 72)
  • Biological evolution and histological of hepatic activity and fibrosis.(at day 0 and Week 72)
  • Biochemical response (ALT at normal value).(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 patients with :seroconversion HBe and HBV DNA below 2.3 log 10 copies per ml(at Week 48)
  • HBV and HIV resistance mutations to tenofovir DF and Emtricitabine.(at Week 72)
  • Treatment adherence(Day 0 to Week 144)

Investigators

Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (2)

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