NCT00051038

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2002

Typical duration for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 3, 2003

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

April 14, 2011

Status Verified

August 1, 2007

Enrollment Period

3.1 years

First QC Date

December 31, 2002

Last Update Submit

April 7, 2011

Conditions

Hepatitis B

Interventions

EntecavirDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

Local Institution

New Haven, Connecticut, United States

Location

Local Institution

Altamonte Springs, Florida, United States

Location

Local Institution

Lousiville, Kentucky, United States

Location

Local Institution

Charlotte, North Carolina, United States

Location

Local Institution

Pittsburgh, Pennsylvania, United States

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

entecavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 31, 2002

First Posted

January 3, 2003

Study Start

September 1, 2002

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

April 14, 2011

Record last verified: 2007-08

Locations

US(5)