Status:
COMPLETED
Efficacy and Tolerance of Peg-interferon Alpha 2a Added to Tenofovir and Emtricitabine in AgHBe Positive HBV-HIV Co-infected Patients
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
Gilead Sciences
Roche Pharma AG
Conditions:
Hepatitis B
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 ...
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 drug...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00391638
Start Date
January 1 2007
End Date
October 1 2012
Last Update
January 15 2015
Active Locations (2)
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1
Service des Maladies Infectieuses CHU
Dijon, France, 21079
2
Service d'Hépato-Gastroentérologie Hopital Hôtel-Dieu
Lyon, France, 69288