Tenofovir in HIV/HBV Coinfection

NCT00192595 | Completed Phase 4 DMC

• 2 other identifiers: VHWG001TICO
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 3

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)

Conditions

HIV Infection; Hepatitis B Coinfection

Keywords

Hepatitis B; HIV; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group

Secondary Outcomes (1)

• -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;

Study Arms (3)

Arm 1:

ACTIVE COMPARATOR

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

Drug: Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)

Arm 2

EXPERIMENTAL

Zidovudine (AZT), tenofovir (TDF), efavirenz (EFV)

Drug: Tenofovir

Amr 3

EXPERIMENTAL

Lamivudine (LAM), tenofovir (TDF), efavirenz (EFV)

Drug: Tenofovir

Interventions

Tenofovir DRUG

Amr 3; Arm 2

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

Arm 1:

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirby Institute: lead
• The University of New South Wales: collaborator
• Gilead Sciences: collaborator

Study Sites (3)

St. Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Thai Red Cross AIDS Research Centre

Bangkok, Thailand

Location

Related Publications (2)

• 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.

  PMID: 22405335 DERIVED

• 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.

  PMID: 18697216 DERIVED

Related Links

• National Centre in HIV Epidemiology and Clinical Research

MeSH Terms

Conditions

HIV Infections; Hepatitis B

Interventions

Tenofovir; Zidovudine; Lamivudine; lipoarabinomannan; efavirenz

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Deoxycytidine; Cytidine

Study Officials

• Greg Dore, MBBS, FRACP

  National Centre in HIV Epidemiology and Clinical Research.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 19, 2005
• Study Start: January 1, 2004
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

TH (1); AU (2)