Clinical trial NCT00033163 (phase 2, status: completed)
Conditions: hiv infections, hepatitis b
ICD codes: Z21, B18.0, B18.1, B19.10, B19.11, B17.0, B16.0, B16.1
Drugs: adefovir dipivoxil, tenofovir disoproxil fumarate
SMILES: CC(C)(C)C(=O)OCOP(=O)(COCCN1C=NC2=C(N)N=CN=C12)OCOC(=O)C(C)(C)C, [H][C@@](C)(CN1C=NC2=C(N)N=CN=C12)OCP(=O)(OCOC(=O)OC(C)C)OCOC(=O)OC(C)C
Eligibility criteria:

        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