Hepatitis B Coinfection, HIV Infection
Conditions
Keywords
Hepatitis B, HIV, Treatment Naive
Brief 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)
Detailed description
A randomised multi-centre trial of tenofovir vs lamivudine vs tenofovir/lamivudine in antiretroviral naïve subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A). Plus, a 12 week viral kinetic sub-study comparing a sub-group of the patients on Clinical Trial A with a group of therapy naïve HBV mono-infected subjects (Substudy A1)
Interventions
DRUGTenofovir
DRUGZidovudine (AZT), lamivudine (LAM), efavirenz (EFV)
Sponsors
The University of New South Wales
Gilead Sciences
Kirby Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group | — |
Secondary
| Measure | Time frame |
|---|---|
| -HBV resistance at 48 weeks; -undetectable HBV DNA at weeks 12 & 24; -HBeAg and HBsAg seroconversion at weeks 24 & 48; -ALT chnages and rate of hepatic cytolysis; -HIV-1 RNA supression and CD4/CD8 changes over 48 weeks; | — |
Countries
Australia, Thailand
Outcome results
None listed