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Entecavir Intensification for Persistent HBV Viremia in HIV-HBV Infection

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 21, 2008
Last Update Posted: May 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of California, San Francisco
Results First Submitted: May 14, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: HIV Infections
Hepatitis B
Interventions: Drug: Entecavir with continued standard of care antiretroviral therapy
Drug: continued standard of care with tenofovir in addition to emtricitabine or lamivudine

  Participant Flow

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Entecavir Intensification Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
Standard of Care continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
Total Total of all reporting groups

Baseline Measures
   Entecavir Intensification   Standard of Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   5   10 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   5   5   10 
>=65 years   0   0   0 
[Units: Participants]
Female   0   0   0 
Male   5   5   10 
Region of Enrollment 
[Units: Participants]
United States   5   5   10 
HBV DNA at enrollment [1] 
[Units: Log10 IU/ML]
Median (Full Range)
 (2.4 to 6.4) 
 (1.9 to 7.7) 
 (1.9 to 7.7) 
[1] hepatitis B DNA level

  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hepatitis B Virus (HBV) DNA   [ Time Frame: week 24 ]

2.  Secondary:   Incidence of Permanent Discontinuation Due to Toxicity   [ Time Frame: 24 weeks ]

3.  Secondary:   Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy)   [ Time Frame: every 4 weeks for 24 weeks ]

4.  Secondary:   Incidence of ALT Flares   [ Time Frame: every 4 weeks for 24 weeks ]

5.  Secondary:   HIV RNA < 75 Copies/ml   [ Time Frame: entry, week 12, and week 24 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information