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Sponsors and Collaborators: |
University of California, San Francisco Bristol-Myers Squibb |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00662545 |
This study will evaluate HIV-HBV infected individuals who have evidence of HBV replication in the blood after taking 48 weeks of more of the HBV active medication tenofovir in combination with emtricitabine or lamivudine. Eligible participants will be randomized to receive 24 weeks of entecavir 1 mg versus continued standard of care antiretroviral therapy. The hypothesis is that intensification with entecavir will reduce HBV DNA at 24 weeks more than continued antiretroviral therapy without entecavir.
Condition | Intervention | Phase |
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HIV Infections Hepatitis B |
Drug: Entecavir with continued standard of care antiretroviral therapy Drug: continued standard of care with tenofovir in addition to emtricitabine or lamivudine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Entecavir Intensification for Persistent HBV Viremia in HIV-HBV Infection |
Estimated Enrollment: | 24 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
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Drug: Entecavir with continued standard of care antiretroviral therapy
1 mg by mouth daily
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B: Active Comparator
continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
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Drug: continued standard of care with tenofovir in addition to emtricitabine or lamivudine
continued standard of care with tenofovir in addition to emtricitabine or lamivudine
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Design: This is a randomized, controlled pilot study of open-label entecavir for the treatment of persistent HBV viremia in HIV-HBV coinfected individuals who have failed to suppress HBV replication after 48 weeks on tenofovir containing therapy.
Primary Objective: To evaluate the mean log reduction of HBV DNA with entecavir intensification in comparison to continued standard therapy with tenofovir and lamivudine/emtricitabine at 24 weeks of therapy
Study Population: HIV-HBV co-infected individuals with detectable HBV DNA after 48 weeks of therapy with tenofovir and lamivudine/emtricitabine whose HIV viremia is well controlled ( < 75 copies at time of enrollment)
Treatment: Subjects will be randomized to continue with standard therapy or to receive intensification with 1 mg daily of open label entecavir for the 24 week duration of the study.
Sample Size: 24 subjects will be enrolled.
Duration 24 weeks of treatment
Primary Endpoint: Mean log10 reduction of HBV DNA at 24 weeks of standard therapy vs. entecavir intensification.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Note: If Bilirubin in elevated, direct and indirect bilirubin levels will be evaluated. If only indirect bilirubin elevated, direct bilirubin will be used for CPT score. If BOTH direct and indirect bilirubin are elevated, total bilirubin will be used for the CPT score.
Female study volunteers must not participate in a conception process (e.g., active attempt to become pregnant). If participating in sexual activity that could lead to pregnancy, the female study volunteer must use the following forms of contraception while receiving study-specific medication(s) and for 30 days after stopping the medication. One of the following methods MUST be used appropriately:
Hormonal-based method
Note: Subjects with concomitant Hepatitis C infection will be permitted to enroll.
Exclusion Criteria:
Contact: Anne Luetkemeyer, MD | 415 476 4082 ext 130 | aluetkemeyer@php.ucsf.edu |
United States, California | |
San Francisco General Hospital | Recruiting |
San Francisco, California, United States, 94110 | |
Principal Investigator: Anne Luetkemeyer, MD |
Principal Investigator: | Anne F Luetkemeyer, MD | HIV/AIDS Division, San Francisco General Hospital, University of California, San Francisco |
Responsible Party: | San Francisco General Hospital, University of California, San Francisco ( Anne Luetkemeyer, MD ) |
Study ID Numbers: | A109324, AI463-162 |
Study First Received: | April 16, 2008 |
Last Updated: | April 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00662545 |
Health Authority: | United States: Institutional Review Board |
HIV Hepatitis B treatment experienced |
Sexually Transmitted Diseases, Viral Liver Diseases Acquired Immunodeficiency Syndrome Lamivudine Hepatitis, Viral, Human Immunologic Deficiency Syndromes Hepatitis Virus Diseases Entecavir Digestive System Diseases |
Emtricitabine HIV Infections Sexually Transmitted Diseases Hepatitis B Tenofovir DNA Virus Infections Viremia Retroviridae Infections Tenofovir disoproxil |
Anti-Infective Agents Communicable Diseases RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Antiviral Agents Hepadnaviridae Infections Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |