Study of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00051038
First received: December 31, 2002
Last updated: April 7, 2011
Last verified: August 2007
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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:
Further study details as provided by Bristol-Myers Squibb:
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
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:
| 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 May 25, 2017