Study of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients
![]() |
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: NCT00051038 |
Recruitment Status :
Completed
First Posted : January 3, 2003
Last Update Posted : April 14, 2011
|
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
Tracking Information | |||
---|---|---|---|
First Submitted Date ICMJE | December 31, 2002 | ||
First Posted Date ICMJE | January 3, 2003 | ||
Last Update Posted Date | April 14, 2011 | ||
Study Start Date ICMJE | September 2002 | ||
Actual Primary Completion Date | October 2005 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE | Not Provided | ||
Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | |||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Study of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients | ||
Official Title ICMJE | A Phase II Study of the Safety and Efficacy of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients Who Have Hepatitis B Viremia While Being Treated With Lamivudine | ||
Brief Summary | The purpose of this clinical research study is to assess the safety and effectiveness of entecavir, when being added to lamivudine, in the treatment of adults with chronic hepatitis B infection who are co-infected with HIV. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 2 Phase 3 |
||
Study Design ICMJE | Primary Purpose: Treatment | ||
Condition ICMJE | Hepatitis B | ||
Intervention ICMJE | Drug: Entecavir | ||
Study Arms ICMJE | Not Provided | ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||
Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Enrollment ICMJE | Not Provided | ||
Original Enrollment ICMJE | Not Provided | ||
Actual Study Completion Date ICMJE | October 2005 | ||
Actual Primary Completion Date | October 2005 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE |
|
||
Sex/Gender ICMJE |
|
||
Ages ICMJE | 16 Years and older (Child, Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00051038 | ||
Other Study ID Numbers ICMJE | AI463-038 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Not Provided | ||
Study Sponsor ICMJE | Bristol-Myers Squibb | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Bristol-Myers Squibb | ||
Verification Date | August 2007 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |