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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00051038
• Other study ID #: AI463-038
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 31, 2002
• Last updated: April 7, 2011
• Start date: September 2002
• Est. completion date: October 2005

Study information

• Verified date: August 2007
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

• 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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Intervention

Drug:
• Entecavir

Locations

Country	Name	City	State
United States	Local Institution	Altamonte Springs	Florida
United States	Local Institution	Charlotte	North Carolina
United States	Local Institution	Lousiville	Kentucky
United States	Local Institution	New Haven	Connecticut
United States	Local Institution	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm