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Entecavir Intensification for Persistent HBV Viremia in HIV-HBV Infection

NCT00662545 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-05-27

Study results available
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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.

Conditions

Interventions

DRUG

Entecavir with continued standard of care antiretroviral therapy

1 mg by mouth daily

DRUG

continued standard of care with tenofovir in addition to emtricitabine or lamivudine

continued standard of care with tenofovir in addition to emtricitabine or lamivudine

Sponsors & Collaborators

Principal Investigators

  • Anne F Luetkemeyer, MD · HIV/AIDS Division, San Francisco General Hospital, University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-02-28
Completion
2010-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00662545 on ClinicalTrials.gov