Entecavir Intensification for Persistent HBV Viremia in HIV-HBV Infection
|HIV Infections Hepatitis B||Drug: Entecavir with continued standard of care antiretroviral therapy Drug: continued standard of care with tenofovir in addition to emtricitabine or lamivudine||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Entecavir Intensification for Persistent Hepatitis B Virus (HBV) Viremia in HIV-HBV Infection|
- Hepatitis B Virus (HBV) DNA [ Time Frame: week 24 ]HBV DNA carries the genetic blueprint of the virus. How many HBV DNA "particles" or "copies" are found in the blood indicates how rapidly the virus is reproducing in the liver.
- Incidence of Permanent Discontinuation Due to Toxicity [ Time Frame: 24 weeks ]
- Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy) [ Time Frame: every 4 weeks for 24 weeks ]
- Incidence of ALT Flares [ Time Frame: every 4 weeks for 24 weeks ]ALT flare: sudden increase in blood level of alanine transaminase (ALT)
- HIV RNA < 75 Copies/ml [ Time Frame: entry, week 12, and week 24 ]
|Study Start Date:||April 2008|
|Study Completion Date:||May 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
Drug: Entecavir with continued standard of care antiretroviral therapy
1 mg by mouth daily
Other Name: Baraclude, Tenofovir, Truvada, Viread, 3TC, FTC, Epivir, Emtriva
Active Comparator: B
continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
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
Other Name: Tenofovir, Truvada, Viread, 3TC, FTC, Epivir, Emtriva
Design: This is a randomized, controlled pilot study of open-label entecavir for the treatment of persistent HBV viremia in HIV-HBV coinfected individuals who have failed to suppress HBV replication after 48 weeks on tenofovir containing therapy.
Primary Objective: To evaluate the mean log reduction of HBV DNA with entecavir(ETV) intensification in comparison to continued standard therapy with tenofovir and lamivudine/emtricitabine at 24 weeks of therapy
Study Population: HIV-HBV co-infected individuals with detectable HBV DNA after 48 weeks of therapy with tenofovir and lamivudine/emtricitabine whose HIV viremia is well controlled ( < 75 copies at time of enrollment)
Treatment: Subjects will be randomized to continue with standard therapy or to receive intensification with 1 mg daily of open label entecavir for the 24 week duration of the study.
Sample Size: 24 subjects will be enrolled.
Duration 24 weeks of treatment
Primary Endpoint: Mean log10 reduction of HBV DNA at 24 weeks of standard therapy vs. entecavir intensification.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662545
|United States, California|
|San Francisco General HIV Clinical Trials Group|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Anne F Luetkemeyer, MD||HIV/AIDS Division, San Francisco General Hospital, University of California, San Francisco|