Adefovir Dipivoxil to Treat Hepatitis B in HIV-Infected Patients
Status:
Completed
Trial end date:
2004-02-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the safety and effectiveness of adding the experimental drug
adefovir dipivoxil to lamivudine for treating hepatitis B virus (HBV) infection in
HIV-infected patients with liver cirrhosis. Adefovir inhibits HBV by interfering with
replication of the virus's genetic material. In some people, the drug has been active against
strains of HBV that are resistant to lamivudine; it may also have some activity against HIV.
HIV-infected patients 21 years of age and older with chronic hepatitis B infection and liver
cirrhosis who have received lamivudine treatment for at least 1 year may be eligible for this
48-week study. Candidates will be screened with a complete medical history, blood tests and a
24-hour urine collection. Blood tests include HLA typing (a test of genetic markers on white
blood cells that permit specialized immunology studies). Within 4 weeks, candidates who
appear eligible for the study will have a physical examination and medical history, an
abdominal ultrasound (imaging test using sound waves) to check for cancer of the liver, chest
X-ray and electrocardiogram (EKG). Blood and urine tests will also be done, and women who can
become pregnant will have a pregnancy test.
Patients who meet the study criteria and decide to participate will then start treatment with
one 10-mg adefovir pill per day by mouth. In addition, patients will continue to take all
other medications prescribed by their doctor. Follow-up clinic visits will be scheduled as
follows:
- Days 1, 3, 5, 7, 10 and 21 - Blood will be drawn for specialized immunology tests and to
measure blood levels of HIV and HBV.
- Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 - Blood and urine (single sample)
tests will be done to determine the side effects of adefovir and its effect on the HBV
infection.
- Week 48 or early termination (end of study) - Blood tests (including tests for hepatitis
C and D), abdominal ultrasound and a 24-hour urine collection to evaluate kidney
function will be done.
- Monthly visits beyond week 48 - Based on the HBV response to treatment and the
availability of the drug from the sponsor, patients may be offered to extend their
treatment with adefovir. Those who continue will have monthly follow-up visits for blood
and urine (single sample) tests.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)