At a glance
ClinicalIndex Comparison Record- ✓Age >18 years
- ✓HBsAg positive for ≥6 months
- ✓HBV-DNA >1 million copies/mL by quantitative PCR
- ✓Elevated ALT or AST (above upper limit of normal) on two determinations ≥1 month apart in past 6 months
- ✕Prior or current adefovir or tenofovir treatment
- ✕HDV coinfection (anti-HDV and HDV antigen present)
- ✕HCV coinfection (anti-HCV and HCV RNA present)
- ✕HIV coinfection (anti-HIV positive)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Combination of Lamivudine and Adefovir Dipivoxil for Treatment of Chronic Hepatitis B
In Brief
A Phase 2 clinical trial evaluating Lamivudine and adefovir and Adefovir alone for HBV (Hepatitis B Virus) and 2 related conditions. Completed, enrolled 41 participants across 1 site.
Detailed Summary
This study will evaluate the safety and effectiveness of lamivudine plus adefovir versus adefovir alone to treat chronic hepatitis B infection. The Food and Drug Administration has approved lamivudine for the treatment of hepatitis B. However, the drug is not effective in all patients, and many of those in whom it initially works develop resistance after 1 to 3 years. Adefovir is an experimental drug that inhibits replication of the hepatitis B virus (HBV). Adefovir used alone may be adequate to provide sustained suppression of the virus and improvement in liver disease. However combining two anti-viral agents may be superior to using one alone, similar to the strategy employed for the treatment of AIDS. This study will test whether the combination of lamivudine and adefovir is better than adefovir alone for the treatment of chronic hepatitis B. Patients 18 years of age and older, who have been infected with HBV for at least 6 months, may be eligible for this study. Candidates may not have received lamivudine treatment in the past 6 months or prior treatment with adefovir and must not be taking other anti-viral treatments for their hepatitis. They will have a blood test to confirm HBV infection. Participants will be admitted to the NIH Clinical Center for 2 to 3 days for a medical evaluation. One to 2 weeks after the evaluation, patients will be randomized to begin taking lamivudine and adefovir, or adefovir alone. Therapy will continue for at least 12 months. Follow-up clinic visits will be scheduled weekly for the first month, then every 4 to 8 weeks for the rest of the treatment period. Patients will be evaluated at the end of 1 year. Patients who have not improved with treatment will stop taking the treatment and will be evaluated in the clinic once every 4 weeks for another 6 months. Patients who show an improvement in their liver injury may continue taking lamivudine and adefovir or adefovir alone for 4 more years, as long as they continue to improve with the medication. Progress will be evaluated. If the test results show no continued improvement or are negative for hepatitis B antigens, therapy will be stopped. Patients who continue treatment for 5 years will be readmitted at year 4 for another medical evaluation to assess the effects of treatment at that time. After the 5 years all patients will stop therapy at and be followed with regular clinic visits for at least 6 months.
Study Details
Timeline
Interventions
Lamivudine (100 mg/day) and adefovir (10 mg/day)
Adefovir (10 mg/day)