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

NCT ID: NCT00391638

Last Updated: 2015-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2012-10-31

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

Conditions

Hepatitis B; HIV Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

TRUVADA (EMTRICITABINE + TENOFOVIR DF)

Intervention Type: DRUG

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

PEGASYS 180μg (Interféron pégylé alpha -2a)

Intervention Type: BIOLOGICAL

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

Interventions

TRUVADA (EMTRICITABINE + TENOFOVIR DF)

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

Intervention Type: DRUG

PEGASYS 180μg (Interféron pégylé alpha -2a)

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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lionel Piroth, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Dijon

Fabrice Carrat, MD

Role: STUDY_CHAIR

Inserm U 707 Paris France

Locations

Service des Maladies Infectieuses CHU

Dijon, , France

Service d'Hépato-Gastroentérologie Hopital Hôtel-Dieu

Lyon, , France

Countries

France

Other Identifiers

ANRS HB 01 EMVIPEG

Identifier Type: -

Identifier Source: secondary_id

2006-004137-15

Identifier Type: -

Identifier Source: org_study_id