Hepatitis B VirusPhase 2NCT00476463
Efficacy of Tenofovir and Emtricitabine in ARV-naive Patients With HIV/HBV Co-infection
A Phase 2 study testing Emtricitabine in people with Hepatitis B Virus and HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
Trial summary
Combination therapy with anti-HBV activity may both increase HBV suppression rates and reduce emergence of resistant strains. Several new therapeutic agents are currently in development, however combination therapy trials in the HBV-infected population have only recently commenced. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hepatitis B Virus, HIV Infections
- What is being tested?
- Emtricitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2005to Dec 2008
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- 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 > 106 copies/ml
- HBsAg positive for > 6 months
- In case documented duration of HBsAg seropositive is less than 6 months (this situation is most likely to occur in patients newly presenting to the HIV-outpatient clinic) the patient is eligible if the patient is:
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- HBsAg positive and
- HBc core IgM antibody negative and
- the liver biopsy gives evidence for a chronic active hepatitis. Thus making it likely that this patient has acquired the HBV infection more than 6 months ago.
- ALT < 10 x ULN
- Creatinine <= 2.0mg/dl
- Platelet count >= 50,000/mm3
- HIV-1 therapy naive
- 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)
- Prior LAM, TDF, or ADV therapy
- Active opportunistic infection
- Other causes of chronic liver disease identified ( autoimmune hepatitis, haemochromatosis, Wilsons disease, alfa-1-antitrypsin deficiency)
- Concurrent malignancy requiring cytotoxic chemotherapy
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virological and Clinical Anti-HBV Efficacy of Tenofovir and Emtricitabine in Antiretroviral Naive Patients With HIV/HBV Co-infection
Combination therapy with anti-HBV activity may both increase HBV suppression rates and reduce emergence of resistant strains. Several new therapeutic agents are currently in development, however combination therapy trials in the HBV-infected population have only recently commenced. No such trials have been undertaken in the HIV/HBV co-infected population.
Read the detailed description
The primary study objective is to compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each treatment group. Virological and clinical anti-HBV efficacy of tenofovir and emtricitabine in antiretroviral naive patients with HIV/HBV co-infection.
- Conditions
- Hepatitis B Virus, HIV Infections
- Being tested
- Emtricitabine
- Keywords
- TDF+FTC, FTC, HIV/HBV, TDF compared to TDF+FTC in HIV/HBV, Treatment Naive
- Medical subject headings
- Hepatitis B, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmtricitabineDrug
Emtricitabine 200 mg OD + Zidovudine 300 mg BID + EFV OD compared to TDF + FTC + EFV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | AZT+FTC+EFV Receives: Drug: Emtricitabine |
| 2 | Active comparator | TDF+FTC+EFV Receives: Drug: Emtricitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV DNA suppression to levels below the limit of detection (<400 copies/ml)
Measured: week 48
Secondary outcomes (10)
HBV suppression as measured by comparison of AUC measurements at 12 and 24 weeks
Measured: 12 and 24 weeks
Proportion of patients with undetectable HBV DNA in serum at 12 and 24 weeks
Measured: 12 and 24 weeks
Rate of HBeAg and HBsAg seroconversion at 12, 24 and 48 weeks.
Measured: 12, 24 and 48 weeks
Rate of emergence of LAM-resistant HBV genotypes at 48 weeks.
Measured: 48 weeks
Rate of hepatic cytolysis (ALT level > 5x ULN).
Measured: 48 weeks
Change from baseline in ALT levels and time to ALT normalization.
Measured: 48 weeks
Suppression of plasma HIV-RNA (< 50 copies/ml) through 48 weeks.
Measured: 48 weeks
Changes in CD4+ /CD8+ cell counts through 48 weeks
Measured: 48 weeks
Toxicity
Measured: 48 weeks
Assessment of effect of therapy on histological changes in the liver and effect on ccc-HBV-DNA
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startApr 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B VirusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, Ministry of Health, Thailand
- Responsible party
- Sponsor
- Investigators
- Kiat Ruxrungtham, MD, Principal investigator, HIV-NAT Thai Red Cross AIDS Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476463
- Sponsor's protocol ID
- HIV-NAT 023
- Status last verified
- Feb 2016
- First submitted
- 20 May 2007
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virological and Clinical Anti-HBV Efficacy of Tenofovir and Emtricitabine in Antiretroviral Naive Patients With HIV/HBV Co-infection
- ClinicalTrials.gov ID
- NCT00476463
- Acronym / sponsor ID
- HIV-NAT 023
- Conditions
- Hepatitis B Virus, HIV Infections
- Keywords
- TDF+FTC, FTC, HIV/HBV, TDF compared to TDF+FTC in HIV/HBV, Treatment Naive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Gilead Sciences, Ministry of Health, Thailand
- Study start
- Apr 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 May 2007 (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.
Combination therapy with anti-HBV activity may both increase HBV suppression rates and reduce emergence of resistant strains. Several new therapeutic agents are currently in development, however combination therapy trials in the HBV-infected population have only recently commenced. No such trials have been undertaken in the HIV/HBV co-infected population.
Detailed description
The primary study objective is to compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each treatment group. Virological and clinical anti-HBV efficacy of tenofovir and emtricitabine in antiretroviral naive patients with HIV/HBV co-infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: EmtricitabineAZT+FTC+EFV |
| 2 | Active comparator | Drug: EmtricitabineTDF+FTC+EFV |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Written informed consent
- Documented HIV infection (positive serology for HIV-1 and detectable HIV-1 RNA)
- Age 18 - 70 years
- HBV DNA > 106 copies/ml
- HBsAg positive for > 6 months
Key exclusion criteria (10 listed)
- HCV-RNA positive or Anti-HAV IgM positive
- Acute hepatitis (serum ALT > 1000 U/L)
- Prior LAM, TDF, or ADV therapy
- Active opportunistic infection
- Other causes of chronic liver disease identified ( autoimmune hepatitis, haemochromatosis, Wilsons disease, alfa-1-antitrypsin deficiency)
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 |
|---|---|---|
| EmtricitabineEmtricitabine 200 mg OD + Zidovudine 300 mg BID + EFV OD compared to TDF + FTC + EFV | Drug | 1, 2 |
Primary outcome
HBV DNA suppression to levels below the limit of detection (<400 copies/ml)
Time frame: week 48
10 secondary outcomes
HBV suppression as measured by comparison of AUC measurements at 12 and 24 weeks
Time frame: 12 and 24 weeks
Proportion of patients with undetectable HBV DNA in serum at 12 and 24 weeks
Time frame: 12 and 24 weeks
Rate of HBeAg and HBsAg seroconversion at 12, 24 and 48 weeks.
Time frame: 12, 24 and 48 weeks
Rate of emergence of LAM-resistant HBV genotypes at 48 weeks.
Time frame: 48 weeks
Rate of hepatic cytolysis (ALT level > 5x ULN).
Time frame: 48 weeks
Change from baseline in ALT levels and time to ALT normalization.
Time frame: 48 weeks
Suppression of plasma HIV-RNA (< 50 copies/ml) through 48 weeks.
Time frame: 48 weeks
Changes in CD4+ /CD8+ cell counts through 48 weeks
Time frame: 48 weeks
Toxicity
Time frame: 48 weeks
Assessment of effect of therapy on histological changes in the liver and effect on ccc-HBV-DNA
Time frame: 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 22 Feb 2016.
- The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)Link 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.
Kiat Ruxrungtham, MD principal investigator
HIV-NAT Thai Red Cross AIDS Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Emtricitabine in people with Hepatitis B Virus and HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
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 14 inclusion and 10 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 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
HBV DNA suppression to levels below the limit of detection (<400 copies/ml) (time frame: week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2016.