Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Chronic HBV infection, defined as positive serum HBsAg for at least 6 months
18 through 75 years of age, inclusive
HBV DNA ≥ 10\^3 IU/mL
Receiving treatment with lamivudine with confirmation of HBV reverse transcriptase mutation(s) known to confer resistance to lamivudine (rtM204I/V with or without rtL180M) by central laboratory assessment prior to randomization; adefovir dipivoxil treatment of ≤ 48 weeks at the time of screening (inclusive of combination adefovir dipivoxil + lamivudine at entry) was allowed
Willing and able to provide written informed consent
Negative serum pregnancy test (for females of childbearing potential only)
Calculated creatinine clearance ≥ 50 mL/min
Hemoglobin ≥ 10 g/dL
Neutrophils ≥ 1000 /mm\^3
No prior oral HBV therapy with approved nucleotide and/or nucleoside therapy or other investigational agents for HBV infection other than lamivudine or adefovir dipivoxil
You may not be if
Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study
Males and females of reproductive potential who are not willing to use an effective method of contraception during the study
Alanine aminotransferase (ALT) ≥ 10 × the upper limit of the normal range (ULN)
Decompensated liver disease
Interferon or pegylated interferon therapy within 6 months of the screening visit
Alpha fetoprotein \> 50 ng/mL
Evidence of hepatocellular carcinoma
Coinfection with hepatitis C virus, HIV, or hepatitis D virus
Significant renal, cardiovascular, pulmonary, or neurological disease
Received solid organ or bone marrow transplantation
Receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion
Proximal tubulopathy
Known hypersensitivity to the study drugs, the metabolites or formulation excipients
Clareo Health | Tenofovir Disoproxil Fumarate (Tenofovir DF) Versus Emtricitabine/Tenofovir DF in Subjects Resistant to Lamivudine
