Tenofovir in HIV/HBV Coinfection

HIV Infection Clinical Trial

— TICO  

Official title:

Virological and Clinical Anti-HBV Efficacy of Tenofovir in Antiretroviral naïve Patients With HIV/HBV Co-infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00192595
• Other study ID #: VHWG001
• Secondary ID: TICO
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2005
• Last updated: March 30, 2015
• Start date: January 2004
• Est. completion date: January 2007

Study information

• Verified date: March 2015
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationThailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coinfection
• Hepatitis B
• Hepatitis B Coinfection
• HIV Infection

Intervention

Drug:
• Tenofovir

• Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)

Locations

Country	Name	City	State
Australia	St. Vincent's Hospital	Darlinghurst	New South Wales
Australia	The Alfred Hospital	Melbourne	Victoria
Thailand	Thai Red Cross AIDS Research Centre	Bangkok

Sponsors (3)

Lead Sponsor	Collaborator
Kirby Institute	Gilead Sciences, The University of New South Wales

Countries where clinical trial is conducted

Australia,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group
Secondary	-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;

External Links

•   National Centre in HIV Epidemiology and Clinical Research