Entecavir Intensification for Persistent HBV Viremia in HIV-HBV Infection
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|ClinicalTrials.gov Identifier: NCT00662545|
Recruitment Status : Completed
First Posted : April 21, 2008
Results First Posted : May 16, 2013
Last Update Posted : May 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Entecavir Intensification for Persistent Hepatitis B Virus (HBV) Viremia in HIV-HBV Infection|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||May 2010|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|