A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV

Inclusion Criteria for All Participants:

• HIV infected
• HBV infected
• Serum HBV DNA of 100,000 copies/ml or greater
• Positive for serum hepatitis B surface antigen (HBsAg) within 12 weeks prior to study entry
• Agree to use acceptable methods of contraception
• Serum alpha-fetoprotein (AFP) of 50 ng/ml or less within 30 days of study entry. If AFP is greater than 50 ng/ml, the patient must have an imaging study of the liver showing no tumor within 30 days prior to study entry

Inclusion Criteria for Population A:

• Uninterrupted stable HAART regimen at study entry for at least 12 continuous weeks prior to study entry
• HIV viral load of 10,000 copies/ml or less within 12 weeks of study entry

Inclusion Criteria for Population A, Group I:

• Compensated liver disease
• Child-Pugh-Turcotte (CPT) score of less than 7

Exclusion Criteria for Population A, Group I:

• Excess fluid in the space between the membranes lining the abdomen and abdominal organs (ascites)
• Gastrointestinal (variceal) bleeding
• Brain and nervous system damage as a result of liver disease
• Abnormal blood clotting time

Inclusion Criteria for Population A, Group II:

• Decompensated liver disease
• CPT score of 7-12

Inclusion Criteria for Population B:

• Prior HAART regimen
• Never taken TDF as part of HAART regimen
• Serum HBV DNA of 100,000 copies/ml or greater within 12 weeks of study entry
• HIV viral load of greater than 10,000 copies/ml within 12 weeks of study entry
• CPT score less than 13

Exclusion Criteria

• Serious kidney problems within the last 12 months
• Allergic or sensitive to ADV or TDF
• Active hepatitis C virus (HCV) disease or unknown HCV status within 24 weeks of study entry
• Any medical or mental illness that, in the opinion of the investigator, would interfere with the protocol
• Past or current alcohol or drug abuse that would affect the protocol
• Malignancy that, in the opinion of the investigator, would make the patient unsuitable for the study
• Certain anti-HBV drugs within 90 days of study entry or expected use of these agents during the course of the study
• Drugs that may damage the kidneys within 8 weeks prior to study screening or expected use of these agents during the course of the study
• Systemic corticosteroids within 90 days of study entry
• Current use of drugs containing pivalic acid
• Certain investigational anti-HIV agents
• Pregnant or breastfeeding