A randomized double-blind controlled evaluation of tenofovir DF versus adefovir dipivoxil for the treatment of presumed pre-core mutant chronic hepatitis B
ID Number 05-0594Principal Investigator(s)
Joseph A Odin
Department(s) or Division(s)
The purpose of this study is to compare the safety and the effectiveness of tenofovir DF (TDF) to that of adefovir dipivoxil (ADV) in patients chronically infected with hepatitis B (HBV). TDF is approved for the treatment of HIV infection in the United States, Australia, and European Union under the trade name Viread®, but it is not approved for the treatment of chronic HBV anywhere in the world. ADV is approved for the treatment ofchronic HBV in the United States, Australia, and European Union under the trade name Hepsera®.
Subjects qualify for participation in this study, because they have been infected with HBV for at least 6 months and have not received any oral treatment for hepatitis B in the past. There will 300 subjects participating at about 120 study sites in 15 countries; about 10 people participating at Mount Sinai. Participation will last about 48 weeks and subjects will be asked to visit the clinic about 14 times.
This is a double blind study in which subjects will be randomized to receive either 1 TDF 300 mg tablet and 1 placebo tablet once daily OR 1 ADV 10 mg tablet and 1 placebo tablet once daily. The randomization for this study is in a 2:1 ratio TDF:ADV. Subjects will undergo the following procedures during their participation in the study: blood draws for routine lab testing; blood draws for hepatitis B, C, and D; blood draw for HIV testing; blood and urine pregnancy for women of childbearing potential; medical history; physical exams; vital signs; liver biopsies; and urinalysis.
Recruiting Patients: Yes