Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 69 of 131 for:    "Hepatitis" | "Lamivudine"

Entecavir Intensification for Persistent HBV Viremia in HIV-HBV Infection

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.
 
ClinicalTrials.gov Identifier: NCT00662545
Recruitment Status : Completed
First Posted : April 21, 2008
Results First Posted : May 16, 2013
Last Update Posted : May 27, 2013
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of California, San Francisco

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
Enrollment 10
Recruitment Details participants recruited from medical clinic, between 7/2008 and 6/2009and 20011
Pre-assignment Details Overall sample size was reduced to 10 due to difficulty in recruitment
Arm/Group Title Entecavir Intensification Standard of Care
Hide Arm/Group Description Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
Period Title: Overall Study
Started 5 5
Completed 5 5
Not Completed 0 0
Arm/Group Title Entecavir Intensification Standard of Care Total
Hide Arm/Group Description Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine Total of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
5
 100.0%
10
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
5
 100.0%
5
 100.0%
10
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 5 participants 10 participants
5 5 10
HBV DNA at enrollment   [1] 
Median (Full Range)
Unit of measure:  Log10 IU/ML
Number Analyzed 5 participants 5 participants 10 participants
3.2
(2.4 to 6.4)
3.8
(1.9 to 7.7)
3.2
(1.9 to 7.7)
[1]
Measure Description: hepatitis B DNA level
1.Primary Outcome
Title Hepatitis B Virus (HBV) DNA
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir Intensification Standard of Care
Hide Arm/Group Description:
Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
Overall Number of Participants Analyzed 5 5
Median (Full Range)
Unit of Measure: log 10 IU/ml
2.4
(0.8 to 2.41)
0.8
(0.8 to 5.8)
2.Secondary Outcome
Title Incidence of Permanent Discontinuation Due to Toxicity
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir Intensification Standard of Care
Hide Arm/Group Description:
Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
Overall Number of Participants Analyzed 5 5
Measure Type: Number
Unit of Measure: participants
0 0
3.Secondary Outcome
Title Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy)
Hide Description [Not Specified]
Time Frame every 4 weeks for 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir Intensification Standard of Care
Hide Arm/Group Description:
Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
Overall Number of Participants Analyzed 5 5
Measure Type: Number
Unit of Measure: participants
0 0
4.Secondary Outcome
Title Incidence of ALT Flares
Hide Description ALT flare: sudden increase in blood level of alanine transaminase (ALT)
Time Frame every 4 weeks for 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir Intensification Standard of Care
Hide Arm/Group Description:
Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
Overall Number of Participants Analyzed 5 5
Measure Type: Number
Unit of Measure: participants
0 0
5.Secondary Outcome
Title HIV RNA < 75 Copies/ml
Hide Description [Not Specified]
Time Frame entry, week 12, and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir Intensification Standard of Care
Hide Arm/Group Description:
Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
Overall Number of Participants Analyzed 5 5
Measure Type: Number
Unit of Measure: participants
5 5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Entecavir Intensification Standard of Care
Hide Arm/Group Description Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
All-Cause Mortality
Entecavir Intensification Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Entecavir Intensification Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Entecavir Intensification Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Anne Luetkemeyer
Organization: UCSF SFGH
Phone: 415 476 4082 ext 130
EMail: aluetkemeyer@php.ucsf.edu
Publications:
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00662545     History of Changes
Other Study ID Numbers: A109324
AI463-162
First Submitted: April 16, 2008
First Posted: April 21, 2008
Results First Submitted: May 14, 2013
Results First Posted: May 16, 2013
Last Update Posted: May 27, 2013