Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Entecavir Intensification for Persistent HBV Viremia in HIV-HBV Infection

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00662545
First received: April 16, 2008
Last updated: May 17, 2013
Last verified: May 2013
Results First Received: May 14, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
participants recruited from medical clinic, between 7/2008 and 6/2009and 20011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Overall sample size was reduced to 10 due to difficulty in recruitment

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Entecavir Intensification     Standard of Care  
STARTED     5     5  
COMPLETED     5     5  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
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  
Number of Participants  
[units: participants]
  5     5     10  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     5     5     10  
>=65 years     0     0     0  
Gender  
[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 )
  3.2  
  ( 2.4 to 6.4 )  
  3.8  
  ( 1.9 to 7.7 )  
  3.2  
  ( 1.9 to 7.7 )  
[1] hepatitis B DNA level



  Outcome Measures
  Hide All Outcome Measures

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

Measure Type Primary
Measure Title Hepatitis B Virus (HBV) DNA
Measure Description 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.
Time Frame week 24  
Safety Issue No  

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.
No text entered.

Reporting Groups
  Description
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

Measured Values
    Entecavir Intensification     Standard of Care  
Number of Participants Analyzed  
[units: participants]
  5     5  
Hepatitis B Virus (HBV) DNA  
[units: log 10 IU/ml]
Median ( Full Range )
  2.4  
  ( 0.8 to 2.41 )  
  0.8  
  ( 0.8 to 5.8 )  

No statistical analysis provided for Hepatitis B Virus (HBV) DNA



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

Measure Type Secondary
Measure Title Incidence of Permanent Discontinuation Due to Toxicity
Measure Description No text entered.
Time Frame 24 weeks  
Safety Issue Yes  

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.
No text entered.

Reporting Groups
  Description
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

Measured Values
    Entecavir Intensification     Standard of Care  
Number of Participants Analyzed  
[units: participants]
  5     5  
Incidence of Permanent Discontinuation Due to Toxicity  
[units: participants]
  0     0  

No statistical analysis provided for Incidence of Permanent Discontinuation Due to Toxicity



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

Measure Type Secondary
Measure Title Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy)
Measure Description No text entered.
Time Frame every 4 weeks for 24 weeks  
Safety Issue Yes  

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.
No text entered.

Reporting Groups
  Description
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

Measured Values
    Entecavir Intensification     Standard of Care  
Number of Participants Analyzed  
[units: participants]
  5     5  
Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy)  
[units: participants]
  0     0  

No statistical analysis provided for Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy)



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

Measure Type Secondary
Measure Title Incidence of ALT Flares
Measure Description ALT flare: sudden increase in blood level of alanine transaminase (ALT)
Time Frame every 4 weeks for 24 weeks  
Safety Issue Yes  

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.
No text entered.

Reporting Groups
  Description
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

Measured Values
    Entecavir Intensification     Standard of Care  
Number of Participants Analyzed  
[units: participants]
  5     5  
Incidence of ALT Flares  
[units: participants]
  0     0  

No statistical analysis provided for Incidence of ALT Flares



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

Measure Type Secondary
Measure Title HIV RNA < 75 Copies/ml
Measure Description No text entered.
Time Frame entry, week 12, and week 24  
Safety Issue No  

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.
No text entered.

Reporting Groups
  Description
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

Measured Values
    Entecavir Intensification     Standard of Care  
Number of Participants Analyzed  
[units: participants]
  5     5  
HIV RNA < 75 Copies/ml  
[units: participants]
  5     5  

No statistical analysis provided for HIV RNA < 75 Copies/ml




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Anne Luetkemeyer
Organization: UCSF SFGH
phone: 415 476 4082 ext 130
e-mail: aluetkemeyer@php.ucsf.edu


Publications:


Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00662545     History of Changes
Other Study ID Numbers: A109324, AI463-162
Study First Received: April 16, 2008
Results First Received: May 14, 2013
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board