Clinical trial NCT00192595: Tenofovir in HIV/HBV Coinfection
Official title: Virological and Clinical Anti-HBV Efficacy of Tenofovir in Antiretroviral naïve Patients With HIV/HBV Co-infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infection
Hepatitis B Coinfection
Keywords: Hepatitis B
HIV
Treatment Naive
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
Collaborators: name: The University of New South Wales
name: Gilead Sciences
First posted: 2005-09-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility 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

Primary outcomes:
measure: To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group
Secondary outcomes:
measure: -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;
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Bangkok
country: Thailand
facility: Thai Red Cross AIDS Research Centre
Study officials:
affiliation: National Centre in HIV Epidemiology and Clinical Research.
name: Greg Dore, MBBS, FRACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Avihingsanon A, Matthews GV, Lewin SR, Marks P, Sasadeusz J, Cooper DA, Bowden S, Locarnini S, Dore GJ, Ruxrungtham K. Assessment of HBV flare in a randomized clinical trial in HIV/HBV coinfected subjects initiating HBV-active antiretroviral therapy in Thailand. AIDS Res Ther. 2012 Mar 9;9(1):6. doi: 10.1186/1742-6405-9-6.
citation: Matthews GV, Avihingsanon A, Lewin SR, Amin J, Rerknimitr R, Petcharapirat P, Marks P, Sasadeusz J, Cooper DA, Bowden S, Locarnini S, Ruxrungtham K, Dore GJ. A randomized trial of combination hepatitis B therapy in HIV/HBV coinfected antiretroviral naive individuals in Thailand. Hepatology. 2008 Oct;48(4):1062-9. doi: 10.1002/hep.22462.