Overview

Entecavir Intensification for Persistent HBV Viremia in HIV-HBV Infection

Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
Summary
This study will evaluate HIV-HBV infected individuals who have evidence of HBV replication in the blood after taking 48 weeks of more of the HBV active medication tenofovir in combination with emtricitabine or lamivudine. Eligible participants will be randomized to receive 24 weeks of entecavir (ETV) 1 mg versus continued standard of care antiretroviral therapy. After 24 weeks, individuals on entecavir or who remain HBV viremic on standard of care will receive ETV o for an additional 24 weeks. The hypothesis is that intensification with entecavir will reduce HBV DNA at 24 weeks more than continued antiretroviral therapy without entecavir.
Phase:
Phase 4
Details
Lead Sponsor:
University of California, San Francisco
Collaborator:
Bristol-Myers Squibb
Treatments:
Anti-Retroviral Agents
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Entecavir
Lamivudine
Tenofovir