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

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00051038

First received: December 31, 2002

Last updated: April 7, 2011

Last verified: August 2007

History of Changes

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 2 Phase 3


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 (Child, Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


ClinicalTrials.gov Identifier:	NCT00051038 History of Changes
Other Study ID Numbers:	AI463-038
Study First Received:	December 31, 2002
Last Updated:	April 7, 2011

Additional relevant MeSH terms:


Hepatitis Hepatitis B Liver Diseases Digestive System Diseases Hepadnaviridae Infections DNA Virus Infections Virus Diseases Hepatitis, Viral, Human Lamivudine	Entecavir Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents

ClinicalTrials.gov processed this record on September 21, 2017

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