Tenofovir in HIV/HBV Coinfection

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to compare the effectiveness of 3 different treatment regimens in reducing or clearing the Hepatitis B Virus in patients infected with HIV and Hepatitis B (co-infection)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kirby Institute
• Collaborators: Gilead Sciences; The University of New South Wales
• Treatments: Efavirenz; Lamivudine; Tenofovir; Zidovudine

Criteria

Inclusion Criteria:

• Written informed consent

• Documented HIV infection (positive serology for HIV-1 and detectable HIV-1 RNA)

• Age 18 - 70 years

• HBV DNA > 105 copies/ml

• HBsAg positive >6 months or HBsAg positive and anti HB core IgM negative

• Creatinine <= 2.0mg/dl (<= 0.2 mmol/L)

• Platelet count >= 50,000/mm

• HIV-1 antiretroviral therapy naïve

• No prior exposure to anti-HBV agents (LAM, adefovir, TDF) although prior IFN treatment allowed

Exclusion Criteria:

• HCV-RNA positive or Anti-HAV IgM positive

• Acute hepatitis (serum ALT > 1000 U/L)

• Active opportunistic infection

• Other causes of chronic liver disease identified (autoimmune hepatitis, hemochromatosis, Wilsons disease, alfa-1-antitrypsin deficiency)

• Concurrent malignancy requiring cytotoxic chemotherapy

• Decompensated or Child's C cirrhosis

• Alfa-fetoprotein (AFP) > 3X ULN (unless negative CT scan or MRI within 3 months of entry date)

• Pregnancy or lactation

• Any other condition which in the opinion of the investigator might interfere with compliance or outcome of the study