Lamivudine and Adefovir to Treat Chronic Hepatitis B Infection in People With and Without HIV Infection
Status:
Completed
Trial end date:
2004-10-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the safety and effectiveness of adefovir plus lamivudine for chronic
hepatitis B infection in people with and without HIV infection. Lamuvidine, an FDA-approved
treatment for hepatitis B infection, also works against HIV. In some patients, the hepatitis
B virus (HBV) continues to reproduce despite lamivudine treatment. Adefovir is an
experimental drug that inhibits HBV replication and may work against some strains of the
virus that have become resistant to lamivudine.
Patients 21 years of age or older with active hepatitis B infection despite treatment with
lamivudine for at least 1 year may be eligible for this 48-week study. Patients both with or
without HIV infection may participate. Candidates will be screened with a medical history,
blood and urine tests, liver ultrasound exam, electrocardiogram (EKG) and chest X-ray.
Participants will have a physical examination, review of their medical history, blood tests,
and a 24-hour urine collection. They will be admitted to the hospital for a liver biopsy to
determine if they can receive the study drug. For this procedure, the patient is given a
sedative for relaxation. The skin over the biopsy is numbed with an anesthetic and the biopsy
needle is passed rapidly into and out of the liver to collect a tissue specimen. Patients are
monitored in the hospital overnight for possible complications. After discharge, they return
home and begin taking the study medications.
Patients will be randomized to two treatment groups. One group will take 10 milligrams/day of
adefovir by mouth, and the other will take a placebo-a lookalike pill with no active
ingredient. Both groups will also take 150 mg lamivudine by mouth and L-carnitine pills or
liquid. Patients with HIV infection will continue to take antiretroviral therapy as well.
Patients will be followed in the clinic at study weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36,
40 and 44 for blood and urine tests to determine the safety of the drug and to evaluate the
response to treatment. On week 48, a repeat 24-hour urine test and repeat liver biopsy will
be done. At the end of the 48 weeks, patients may continue to receive adefovir for another 48
weeks and possibly longer. All those who participate in this extension phase will receive
active adefovir, regardless of whether they had previously taken adefovir or placebo.
All patients will have the option to enroll in a separate study to examine the levels of HBV
(and levels of HIV in HIV-infected patients) in the blood immediately after starting
treatment and to determine if these initial levels can predict later outcome. This involves
seven additional visits, for which participants will be compensated. At these visits, blood
will be drawn on study days 0 (before starting drug treatment), 1, 3, 5, 7, 10 and 21 for HIV
and HBV viral loads and specialized immunology tests.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)