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

This study has been completed.

First Received on December 31, 2002. Last Updated on April 7, 2011 History of Changes

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00051038

Purpose

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.

Condition	Intervention	Phase
Hepatitis B	Drug: Entecavir	Phase II Phase III

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Lamivudine Entecavir

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Study Start Date:	September 2002
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051038

Locations

United States, Connecticut
Local Institution
New Haven, Connecticut, United States
United States, Florida
Local Institution
Altamonte Springs, Florida, United States
United States, Kentucky
Local Institution
Lousiville, Kentucky, United States
United States, North Carolina
Local Institution
Charlotte, North Carolina, United States
United States, Pennsylvania
Local Institution
Pittsburgh, Pennsylvania, United States

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00051038 History of Changes
Other Study ID Numbers:	AI463-038
Study First Received:	December 31, 2002
Last Updated:	April 7, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

Lamivudine
Entecavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 13, 2012