Study of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients - Tabular View

Tracking Information
First Received Date ^ICMJE	December 31, 2002
Last Updated Date	June 27, 2008
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00051038 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

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
Study Phase	Phase II, Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Hepatitis B
Intervention ^ICMJE	Drug: Entecavir
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Documented history of co-infection with HIV and HBV Stable Anti Retroviral Therapy regimen containing lamivudine 150 mg BID for at least 24 weeks prior to enrollment; Documented HBV viremia on screening and at least at 4 weeks prior to screening HBe Ag-positive or HBe Ag-negative / anti-HBe-positive HIV viral load below 400 copies/mL by the Roche Amplicor(TM) 1.5 HIV PCR assay at screening and equally low at least 12 weeks prior to screening Absence of Co-Infection with hepatitis C virus (HCV) or hepatitis D virus (HDV) Absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease Less that 1/2 weeks of prior therapy with nucleoside/nucleotide analogue (excluding lamivudine) with activity against HBV (including e.g. famciclovir, tenofovir, ganciclovir, adefovir). No receipt of any of these therapies within 24 weeks prior to randomization into this study.
Gender	Both
Ages	16 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00051038
Responsible Party
Study ID Numbers ^ICMJE	AI463-038
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	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