CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 10 enrolled
Drug / intervention
Entecavir with continued standard of care antiretroviral therapy +1 moredrug
Likely dose
Entecavir with continued standard of care antiretroviral therapy 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00662545
NCT00662545Phase 4Completed
CompareCT.gov

Entecavir Intensification for Persistent Hepatitis B Virus (HBV) Viremia in HIV-HBV Infection

University of California, San Francisco·interventional·Posted Apr 21, 2008·Updated May 27, 2013

In Brief

A Phase 4 clinical trial evaluating Entecavir with continued standard of care antiretroviral therapy and continued standard of care with tenofovir in addition to emtricitabine or lamivudine for HIV Infections and Hepatitis B. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Hepatitis B
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 21, 2008
Enrollment StartApr 1, 2008
Primary CompletionFeb 1, 2010
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.2 years ago

Interventions

Entecavir with continued standard of care antiretroviral therapydrug

1 mg by mouth daily

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

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