Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
The HIV Netherlands Australia Thailand Research Collaboration
With
Gilead Sciences
Ministry of Health, Thailand
The primary study objective is to compare HBV DNA suppression to levels below the limit of detection (\<400 copies/ml) by week 48 in each treatment group. Virological and clinical anti-HBV efficacy of tenofovir and emtricitabine in antiretroviral naive patients with HIV/HBV co-infection.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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
You may not be if
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)
