A Surveillance Program for the Detection of Hepatitis B Virus (HBV) Resistance to Tenofovir in HIV-HBV co-Infected Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00660361 |
Recruitment Status
: Unknown
Verified April 2008 by Bayside Health.
Recruitment status was: Recruiting
First Posted
: April 17, 2008
Last Update Posted
: April 17, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
HIV Infections Hepatitis B Virus |
Tenofovir disoproxil fumarate (TDF) is a nucleotide analogue that can inhibit both HIV and HBV DNA polymerases, and is active against wild-type HBV and HBV strains that contain lamivudine-associated polymerase gene mutations (Dore, Cooper et al. 2004). TDF was approved for use, in combination with other antiretrovirals, for HIV therapy in April 2002 in Australia. It is not currently approved for use in Australia for treatment of HBV mono-infection. TDF has only recently become available in Thailand where HIV/HBV co-infected individuals are predominantly infected with genotype B and C. In contrast, in Australia and Europe, the dominant HBV genotype in HIV/HBV co-infected individuals is A and D. As with all antiviral agents there is concern with long-term use and the development of resistance.
There has been a report of a signature mutation leading to TDF resistance at rtA194T (Sheldon et al., 2005). We recently conducted a retrospective study of HIV/HBV co infected individuals in Melbourne who had received TDF for at least 3 months. Twenty-eight patients had samples available on TDF of which four (~14%) had detectable HBV DNA by PCR. We did not identify the mutation rtA194T or rtV214A/Q215S in individuals failing TDF and found that the only persisting mutations were LMV-resistant mutations. These findings highlight the need for a surveillance system for HIV-HBV co-infected individuals receiving TDF for the detection of novel mutations in the four major HBV genotypes. In addition, it is important to determine the clinical and virological risk factors for TDF failure. This is particularly important given that these agents will be used indefinitely in this patient population and with the development of unique drug resistant mutations there will be implications for progression of liver disease and future therapeutic choices.
This study will recruit patients who are co-infected with HIV and HBV, and are currently taking or who are about to commence the anti-HIV drug TDF. The study cohort will include HIV-HBV co-infected individuals from the Alfred Hospital and Melbourne Sexual Health Clinic. Other sites, not covered by this application, are St Vincent's Hospital, Sydney and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
The aim of the study is to identify any changes in the HBV DNA that might be associated with resistance to TDF, to determine how long any changes take to occur and to determine the effect of these changes on the clinical response to TDF.
This will be achieved by 6 monthly assessment over a 2 year period, with medical history, physical examination, routine clinical investigations, hepatitis B activity and HBV DNA sequencing.
Study Type : | Observational |
Estimated Enrollment : | 92 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Surveillance Program for the Detection of Hepatitis B Virus (HBV) Resistance to Tenofovir (TDF) in HIV-HBV co-Infected Patients |
Study Start Date : | April 2008 |
Estimated Primary Completion Date : | April 2010 |
Estimated Study Completion Date : | September 2010 |
Group/Cohort |
---|
A
individuals co-infected with HIV-HBV and receiving tenofovir as aprt of their HAART regimen
|

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 18 years of age and older
- HIV positive
- 2 positive Hepatitis B surface antigen results at least 6 months apart
- currently receiving (or about to commence) tenofovir therapy
Exclusion Criteria:
- unable to provide informed consent
- lack of a serum sample prior to commencing tenofovir

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660361
Contact: Jennifer Audsley, PhD | 613-9903-0184 | jennifer.audsley@med.monash.edu.au |
Australia, Victoria | |
The Alfred Hospital | Recruiting |
Melbourne, Victoria, Australia, 3004 | |
Contact: Jennifer Audsley, PhD 613-9903-0184 jennifer.audsley@med.monash.edu.au | |
Sub-Investigator: Jennifer Hoy | |
Principal Investigator: Joe Sasadeusz | |
Sub-Investigator: David Iser |
Principal Investigator: | Sharon L, MD, PhD | The Alfred Hospital and Monash University |
Responsible Party: | Professor Sharon Lewin, The Alfred Hospital and Monash University |
ClinicalTrials.gov Identifier: | NCT00660361 History of Changes |
Other Study ID Numbers: |
ALF-50/08 |
First Posted: | April 17, 2008 Key Record Dates |
Last Update Posted: | April 17, 2008 |
Last Verified: | April 2008 |
Keywords provided by Bayside Health:
HIV HBV co-infection |
drug resistance tenofovir HIV-HBV co-infection |
Additional relevant MeSH terms:
Infection Hepatitis Hepatitis A HIV Infections Hepatitis B Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Hepadnaviridae Infections DNA Virus Infections Tenofovir Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents |