Efficacy of Tenofovir and Emtricitabine in ARV-naive Patients With HIV/HBV Co-infection

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Combination therapy with anti-HBV activity may both increase HBV suppression rates and reduce emergence of resistant strains. Several new therapeutic agents are currently in development, however combination therapy trials in the HBV-infected population have only recently commenced. No such trials have been undertaken in the HIV/HBV co-infected population.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborators: Gilead Sciences; Ministry of Health, Thailand
• Treatments: Emtricitabine; Tenofovir

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 > 106 copies/ml

• HBsAg positive for > 6 months

In case documented duration of HBsAg seropositive is less than 6 months (this situation is most likely to occur in patients newly presenting to the HIV-outpatient clinic) the patient is eligible if the patient is:

1. HBsAg positive and

2. HBc core IgM antibody negative and

3. the liver biopsy gives evidence for a chronic active hepatitis. Thus making it likely that this patient has acquired the HBV infection more than 6 months ago.

• ALT < 10 x ULN

• Creatinine <= 2.0mg/dl

• Platelet count >= 50,000/mm3

• HIV-1 therapy naive

• 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)

• Prior LAM, TDF, or ADV therapy

• Active opportunistic infection

• Other causes of chronic liver disease identified ( autoimmune hepatitis, haemochromatosis, 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