HIV InfectionPhase 4TICONCT00192595
Tenofovir in HIV/HBV Coinfection
A Phase 4 study testing Tenofovir and Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV) in people with HIV Infection and Hepatitis B Coinfection, run by Kirby Institute at 3 sites in 2 countries.
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) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV Infection, Hepatitis B Coinfection
- What is being tested?
- Tenofovir and Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2004to Jan 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Australia2 sites
St. Vincent's Hospital
Darlinghurst, New South Wales, 2010
The Alfred Hospital
Melbourne, Victoria, 3004
About this study
Official title: Virological and Clinical Anti-HBV Efficacy of Tenofovir in Antiretroviral naïve Patients With HIV/HBV Co-infection
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)
Read the 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)
- Conditions
- HIV Infection, Hepatitis B Coinfection
- Being tested
- Tenofovir, Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)
- Keywords
- Hepatitis B, HIV, Treatment Naive
- Medical subject headings
- HIV Infections, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenofovirDrug
Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: | Active comparator | Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV) Receives: Drug: Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV) |
| Arm 2 | Experimental | Zidovudine (AZT), tenofovir (TDF), efavirenz (EFV) Receives: Drug: Tenofovir |
| Amr 3 | Experimental | Lamivudine (LAM), tenofovir (TDF), efavirenz (EFV) Receives: Drug: Tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- The University of New South Wales, Gilead Sciences
- Investigators
- Greg Dore, MBBS, FRACP, Principal investigator, National Centre in HIV Epidemiology and Clinical Research.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192595
- Sponsor's protocol ID
- VHWG001
- Other IDs
- TICO
- Acronym
- TICO
- Status last verified
- Mar 2015
- First submitted
- 11 Sep 2005
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22405335Matthews 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.
PubMed 18697216
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virological and Clinical Anti-HBV Efficacy of Tenofovir in Antiretroviral naïve Patients With HIV/HBV Co-infection
- ClinicalTrials.gov ID
- NCT00192595
- Acronym / sponsor ID
- TICO / VHWG001
- Conditions
- HIV Infection, Hepatitis B Coinfection
- Keywords
- Hepatitis B, HIV, Treatment Naive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- The University of New South Wales, Gilead Sciences
- Study start
- Jan 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: | Active comparator | Drug: Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV) |
| Arm 2 | Experimental | Drug: TenofovirZidovudine (AZT), tenofovir (TDF), efavirenz (EFV) |
| Amr 3 | Experimental | Drug: TenofovirLamivudine (LAM), tenofovir (TDF), efavirenz (EFV) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir | Drug | Amr 3, Arm 2 |
| Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV) | Drug | Arm 1: |
Primary outcome
To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group
1 secondary outcome
-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;
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Derived from this study: PubMed 22405335Avihingsanon 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.
- Derived from this study: PubMed 18697216Matthews 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.
- National Centre in HIV Epidemiology and Clinical ResearchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greg Dore, MBBS, FRACP principal investigator
National Centre in HIV Epidemiology and Clinical Research.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir and Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV) in people with HIV Infection and Hepatitis B Coinfection, run by Kirby Institute at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00192595, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.