Tenofovir in HIV/HBV Coinfection (NCT00192595) | Clinical Trial Compass
CompletedPhase 4
Tenofovir in HIV/HBV Coinfection
Australia, Thailand36 participantsStarted 2004-01
Plain-language 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)
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group