|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00051090 |
Purpose
This study will evaluate the drug telbivudine (LdT) for treatment of hepatitis B virus (HBV) in HIV infected patients. Patients will take telbivudine alone for 24 weeks, add anti-HIV drugs for 24 weeks, then stop taking telbivudine while continuing their anti-HIV drug regimen. To enroll in this study, patients must not be taking any anti-HIV drugs and cannot have taken more than 31 days of treatment with lamivudine (3TC), protease inhibitors (PIs), or nonnucleoside reverse transcriptase inhibitors (NNRTIs).
| Condition | Intervention |
|---|---|
|
HIV Infections Hepatitis B |
Drug: Telbivudine Drug: Lamivudine Drug: Efavirenz Drug: Didanosine Drug: Abacavir |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Multicenter, Pilot Study of Telbivudine (LdT) Anti-HBV Treatment Prior to the Initiation of Highly Active Antiretroviral Therapy Containing Lamivudine in Subjects Coinfected With HBV and HIV |
| Estimated Enrollment: | 36 |
| Study Start Date: | January 2003 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
All eligible study participants
|
Drug: Telbivudine
Administered orally at a daily dosage of 600 mg for a period of 48 weeks
Drug: Lamivudine
Administered orally at a total daily dosage of 300 mg for Weeks 24-48
Drug: Efavirenz
Administered orally at a daily dose of 600 mg
Drug: Didanosine
Administered orally at a total dosage of either 400 mg or 250 mg determined by individual weight
Drug: Abacavir
Administered orally twice daily in doses of 300 mg
|
Studies indicate that 70% to 80% of HIV infected patients have or have had HBV infection and that 10% are HBV carriers. Lamivudine therapy for treatment of HBV in HIV infected patients has limited long-term efficacy due to the development of resistance mutations. Telbivudine is a thymidine analogue with excellent HBV inhibitory activity but no anti-HIV activity. The primary objective of this study is to evaluate the safety and anti-HBV activity of telbivudine alone and in combination with a lamivudine-based highly active antiretroviral therapy (HAART) regimen in patients coinfected with HBV and HIV.
Patients in this study will take telbivudine for 24 weeks. At Week 24, patients will add a HAART regimen containing lamivudine and efavirenz plus either didanosine or abacavir. Patients who are unable to add a HAART regimen at Week 24 due to lab abnormalities or other contraindications will be allowed to delay the initiation of HAART until Week 30. Patients may initiate HAART prior to Week 24 if deemed medically necessary by the primary HIV care provider. Patients will take both telbivudine and HAART for 24 weeks. At Week 48, patients will discontinue telbivudine and continue on the HAART regimen alone for an additional 12 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35924-2050 | |
| United States, Illinois | |
| Cook County Hosp Core Ctr | |
| Chicago, Illinois, United States, 60612 | |
| Northwestern Univ | |
| Chicago, Illinois, United States, 60611-3015 | |
| United States, Missouri | |
| Washington University (St. Louis) | |
| St. Louis, Missouri, United States, 63108-2138 | |
| Study Chair: | Patrick Lynch, M.D. | Northwestern University |
More Information
| Responsible Party: | DAIDS ( Rona Siskind ) |
| Study ID Numbers: | ACTG A5167 |
| Study First Received: | January 3, 2003 |
| Last Updated: | September 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00051090 History of Changes |
| Health Authority: | United States: Federal Government |
|
Hepatitis B Antiretroviral Therapy, Highly-Active HIV Infections Lamivudine |
Reverse Transcriptase Inhibitors Antiviral Agents Drug Therapy, Combination Treatment Naive |
|
Antimetabolites Efavirenz Sexually Transmitted Diseases, Viral Liver Diseases Anti-HIV Agents Acquired Immunodeficiency Syndrome Lamivudine Hepatitis, Viral, Human Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors |
Hepatitis Virus Diseases Didanosine Digestive System Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Hepatitis B DNA Virus Infections Abacavir Retroviridae Infections |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Liver Diseases Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Hepatitis, Viral, Human Lamivudine Infection Hepadnaviridae Infections Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Hepatitis B Retroviridae Infections |
Nucleic Acid Synthesis Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases Didanosine HIV Infections Sexually Transmitted Diseases |
