Lamivudine and Therapeutic Vaccine Evaluation in Senegalese Patients With Chronic Hepatitis B Infection (ANRS 12100 HEPADAK-2)

• Status: Terminated
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic hepatitis B infection is a major public health issue in Senegal. The study will compare the efficacy of the treatment strategy combining Lamivudine and therapeutic vaccine (12 intra-muscular injections over a 6-month period) to a treatment with Lamivudine alone on the control of viral replication in patients with a replicative hepatitis B virus (HBV) infection and an increase in hepatic enzymes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborator: GlaxoSmithKline
• Treatments: Lamivudine; Vaccines

Criteria

Inclusion Criteria:

• Written informed consent

• Liver biopsy acceptation

• B hepatitis grade over or equal to F2 Metavir score

• DNA HBV greater than 100000 copies/mL (or 10000 copies/mL if Ag Hbe negative)

• ALAT greater than 1.3 times the upper normal limit

Exclusion Criteria:

• HCV, HDV and HIV positive

• Pregnancy

• Decompensated liver cirrhosis

• Pretreated patient