Study of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00051038 |
Recruitment Status :
Completed
First Posted : January 3, 2003
Last Update Posted : April 14, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis B | Drug: Entecavir | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
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 |
Study Start Date : | September 2002 |
Actual Primary Completion Date : | October 2005 |
Actual Study Completion Date : | October 2005 |


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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051038
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 |
ClinicalTrials.gov Identifier: | NCT00051038 |
Other Study ID Numbers: |
AI463-038 |
First Posted: | January 3, 2003 Key Record Dates |
Last Update Posted: | April 14, 2011 |
Last Verified: | August 2007 |
Hepatitis B Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Hepadnaviridae Infections DNA Virus Infections Entecavir Antiviral Agents Anti-Infective Agents |