Efficacy and Tolerance of Peg-interferon Alpha 2a Added to Tenofovir and Emtricitabine in AgHBe Positive HBV-HIV Co-infected Patients (HB01EMVIPEG)
This study has been completed.
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
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 )
ClinicalTrials.gov Identifier:
NCT00391638
First received: October 23, 2006
Last updated: January 14, 2015
Last verified: January 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hepatitis B HIV Infections |
Drug: TRUVADA (EMTRICITABINE + TENOFOVIR DF) Biological: PEGASYS 180μg (Interféron pégylé alpha -2a) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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. |
Resource links provided by NLM:
Drug Information available for:
Interferon
Interferon Alfa-2a
Emtricitabine
Tenofovir
Peginterferon Alfa-2a
Tenofovir Disoproxil Fumarate
Truvada
U.S. FDA Resources
Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
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 [ Time Frame: at Week 72 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- proportion of patients with negative HBe antigen. [ Time Frame: at Week 72 and Week 144 ] [ Designated as safety issue: No ]
- proportion of patients with HBV DNA under 2.3 log 10 copies per ml. [ Time Frame: at Week 72 and Week 144 ] [ Designated as safety issue: No ]
- proportion of seroconversion HBs. [ Time Frame: at Week 72 and Week 144 ] [ Designated as safety issue: No ]
- proportion of patients with no more HBs antigen. [ Time Frame: at Week 72 and Week 144 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Biological evolution and histological of hepatic activity and fibrosis. [ Time Frame: at day 0 and Week 72 ] [ Designated as safety issue: No ]
- Biochemical response (ALT at normal value). [ Time Frame: at Week 72 and Week 144 ] [ Designated as safety issue: No ]
- proportion of patients with :seroconversion HBe and HBV DNA below 2.3 log 10 copies per ml [ Time Frame: at Week 48 ] [ Designated as safety issue: No ]
- HBV and HIV resistance mutations to tenofovir DF and Emtricitabine. [ Time Frame: at Week 72 ] [ Designated as safety issue: No ]
- Immunological and virological evolution of HIV infection. [ Time Frame: between Day 0 and Week 144 ] [ Designated as safety issue: No ]
- Safety [ Time Frame: between Day 0 and Week 144 ] [ Designated as safety issue: Yes ]
- Quality of life [ Time Frame: Day 0, Week 12, Week 24, Week 48, Week 72 ] [ Designated as safety issue: No ]
- Treatment adherence [ Time Frame: Day 0 to Week 144 ] [ Designated as safety issue: No ]
| Enrollment: | 56 |
| Study Start Date: | January 2007 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00391638
Please refer to this study by its ClinicalTrials.gov identifier: 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
| 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 |
| Study First Received: | October 23, 2006 |
| Last Updated: | January 14, 2015 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
|
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 Interferon-alpha Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Tenofovir Emtricitabine Peginterferon alfa-2a Interferons Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 26, 2016