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
|
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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 |
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 |

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
|
- 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 ]
- proportion of patients with negative HBe antigen. [ Time Frame: at Week 72 and Week 144 ]
- proportion of patients with HBV DNA under 2.3 log 10 copies per ml. [ Time Frame: at Week 72 and Week 144 ]
- proportion of seroconversion HBs. [ Time Frame: at Week 72 and Week 144 ]
- proportion of patients with no more HBs antigen. [ Time Frame: 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. [ Time Frame: before tenofovir treatment, duration of tenofovir treatment before study ]
- Biological evolution and histological of hepatic activity and fibrosis. [ Time Frame: at day 0 and Week 72 ]
- Biochemical response (ALT at normal value). [ Time Frame: at Week 72 and Week 144 ]
- proportion of patients with :seroconversion HBe and HBV DNA below 2.3 log 10 copies per ml [ Time Frame: at Week 48 ]
- HBV and HIV resistance mutations to tenofovir DF and Emtricitabine. [ Time Frame: at Week 72 ]
- Immunological and virological evolution of HIV infection. [ Time Frame: between Day 0 and Week 144 ]
- Safety [ Time Frame: between Day 0 and Week 144 ]
- Quality of life [ Time Frame: Day 0, Week 12, Week 24, Week 48, Week 72 ]
- Treatment adherence [ Time Frame: Day 0 to Week 144 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | 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-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

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
France | |
Service des Maladies Infectieuses CHU | |
Dijon cedex, France, 21079 | |
Service d'Hépato-Gastroentérologie Hopital Hôtel-Dieu | |
Lyon Cedex 02, France, 69288 |
Principal Investigator: | Lionel Piroth, MD | Centre Hospitalier Universitaire Dijon | |
Study Chair: | Fabrice Carrat, MD | Inserm U 707 Paris France |
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 |