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

NCT00391638 | Completed Phase 2 DMC

• 2 other identifiers: 2006-004137-15ANRS HB 01 EMVIPEG
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatitis B; HIV Infections

Keywords

HIV and Hepatitis B coinfection; Peg interferon; tenofovir; emtricitabine; Hepatitis B e Antigens; Treatment Experienced

Outcome Measures

Primary Outcomes (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

  at Week 72

Secondary Outcomes (13)

• 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

Study Arms (1)

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

Drug: TRUVADA (EMTRICITABINE + TENOFOVIR DF); Biological: PEGASYS 180μg (Interféron pégylé alpha -2a)

Interventions

TRUVADA (EMTRICITABINE + TENOFOVIR DF) DRUG

Truvada ® (200 mg tablet of 300 mg of emtricitabine + tenofovir DF) Dosage 1 tablet taken orally once a day

HIV antiretroviral therapy, TRUVADA , PEGASYS 180μg

PEGASYS 180μg (Interféron pégylé alpha -2a) BIOLOGICAL

Pegasys ® injection 180μg Dosage: A subcutaneous injection per week

HIV antiretroviral therapy, TRUVADA , PEGASYS 180μg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead
• Gilead Sciences: collaborator
• Roche Pharma AG: collaborator

Study Sites (2)

Service des Maladies Infectieuses CHU

Dijon, 21079, France

Location

Service d'Hépato-Gastroentérologie Hopital Hôtel-Dieu

Lyon, 69288, France

Location

MeSH Terms

Conditions

Hepatitis B; HIV Infections

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Tenofovir; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Lionel Piroth, MD

  Centre Hospitalier Universitaire Dijon

  PRINCIPAL INVESTIGATOR

• Fabrice Carrat, MD

  Inserm U 707 Paris France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2006
• First Posted: October 24, 2006
• Study Start: January 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: October 1, 2012
• Last Updated: January 15, 2015

Record last verified: 2015-01

Locations

FR (2)