HIV InfectionsPhase 4NCT00127959

Virological and Clinical Anti-Hepatitis B Virus (HBV) Efficacy of Tenofovir and Emtricitabine in Patients With HIV/HBV co-Infection

A Phase 4 study testing tenofovir, emtricitabine and zidovudine in people with HIV Infections and Hepatitis B, run by International Antiviral Therapy Evaluation Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a randomized multicentre trial of emtricitabine (FTC) versus tenofovir (TDF)/FTC in antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A). Plus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted. (Substudy A1) Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: HIV Infections, Hepatitis B
What is being tested?: tenofovir, emtricitabine and zidovudine
How many people: 24 participants
Where: 1 siteNetherlands
Study dates: Mar 2004to Aug 2006
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
Age 18 - 70 years
HBV DNA > 10E6 copies/ml
ALT < 10 x ULN (upper limit of normal)
Creatinine <= 2.0mg/dl

Show all 9Show fewer

Platelet count >= 50,000/mm3
HIV-1 therapy naive
No prior exposure to anti-HBV agents

Who cannot join

Hepatitis C viral RNA (CV-RNA) positive or Anti-hepatitis A virus immunoglobulin M (HAV IgM) positive
Acute hepatitis (serum ALT > 1000 U/L)
Prior LAM, TDF, or adefovir dipivoxil (ADV) therapy
Active opportunistic infection
Pregnancy or lactation
Other chronic liver disease

Show all 9Show fewer

Concurrent malignancy requiring cytotoxic chemotherapy
Decompensated or Child's C cirrhosis
Alfa-fetoprotein (AFP) > 3X ULN (unless negative computed tomography [CT] scan or magnetic resonance imaging [MRI] within 3 months of entry date)

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Academic Medical Center
Amsterdam, North Holland, 1105AZ

Other trials in Netherlands

About this study

Official title: Virological and Clinical Anti-HBV Efficacy of Tenofovir and Emtricitabine in Antiretroviral Naïve Patients With HIV/HBV co-Infection

This is a randomized multicentre trial of emtricitabine (FTC) versus tenofovir (TDF)/FTC in antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A).

Plus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted. (Substudy A1)

Read the detailed description

This is a randomized multicentre trial of FTC vs TDF/FTC in antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A).

Plus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted. (Substudy A1)

Primary Objectives:

To compare the proportion of subjects with HBV DNA levels below the limit of detection (<400 copies/ml) by week 48 in each treatment group

Secondary Objectives:

To evaluate the emergence of HBV resistance at 48 weeks
To compare the proportion of patients with undetectable HBV DNA at weeks 12 and 24 in each treatment group
To compare the proportion of patients who achieve HBeAg and HBsAg seroconversion at weeks 12, 24 and 48 during the study
To compare changes in ALT from baseline and the rate of hepatic cytolysis (ALT>5x ULN)
To compare suppression of HIV-1 RNA and changes in CD4/CD8 counts over 48 weeks
To compare the effect of therapy on histological changes in the liver and the presence of ccc-DNA

Enrollment:

24 patients in Clinical trial A (of whom 16 enter substudy A1).

Clinical Trial A:

Patients with HIV/HBV co-infection who are naive to HIV/HBV therapy, have detectable HBV viraemia and are willing to start antiretroviral therapy.

Inclusion Criteria:

Written informed consent
Documented HIV infection
Age 18 - 70 years
HBV DNA > 106 copies/ml

Randomization:

Arm 1: Zidovudine (AZT), emtricitabine (FTC), efavirenz (EFV)
Arm 2: Tenofovir (TDF), emtricitabine (FTC), efavirenz (EFV)

Conditions: HIV Infections, Hepatitis B
Being tested: tenofovir, emtricitabine, zidovudine, efavirenz
Keywords: HIV-1, HBV, treatment, tenofovir, emtricitabine, Treatment Naive, HIV-1 infection, Hepatitis B virus infection
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
emtricitabineDrug
zidovudineDrug
efavirenzDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

HBV DNA suppression as measured by comparison of area under the curve (AUC) measurements after 48 weeks therapy

Secondary outcomes (6)

Proportion of patients with undetectable HBV DNA in serum
Rate of hepatitis B e antigen (HBeAg) and hepatitis B surface antigen (HBsAg) seroconversion
Rate of emergence of lamivudine (LAM)-resistant HBV genotypes
Suppression of plasma HIV-RNA (< 50 copies/ml)
Changes in CD4+ /CD8+ cell counts
Presence of covalently closed circle DNA (cccDNA) on liver biopsy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2004Aug 2006

First posted9 Aug 2005 (estimated)
Study startMar 2004
Study completionAug 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionsStudies 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: Single group
Masking: None (open label)
Enrolment: 24 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00127959
Sponsor's protocol ID: IAT-0038-04
Status last verified: Apr 2007
First submitted: 8 Aug 2005
Last updated: 24 Apr 2007
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2007. 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 Naïve Patients With HIV/HBV co-Infection
ClinicalTrials.gov ID: NCT00127959
Acronym / sponsor ID: IAT-0038-04
Conditions: HIV Infections, Hepatitis B
Keywords: HIV-1, HBV, treatment, tenofovir, emtricitabine, Treatment Naive, HIV-1 infection, Hepatitis B virus infection
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants
Lead sponsor: International Antiviral Therapy Evaluation CenterUniversity, hospital or other
Collaborators: Gilead Sciences
Study start: Mar 2004
Study completion: Aug 2006 (actual)
First posted: 9 Aug 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.

This is a randomized multicentre trial of emtricitabine (FTC) versus tenofovir (TDF)/FTC in antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A).

Plus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted. (Substudy A1)

Detailed description

This is a randomized multicentre trial of FTC vs TDF/FTC in antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A).

Plus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted. (Substudy A1)

Primary Objectives:

To compare the proportion of subjects with HBV DNA levels below the limit of detection (<400 copies/ml) by week 48 in each treatment group

Secondary Objectives:

To evaluate the emergence of HBV resistance at 48 weeks
To compare the proportion of patients with undetectable HBV DNA at weeks 12 and 24 in each treatment group
To compare the proportion of patients who achieve HBeAg and HBsAg seroconversion at weeks 12, 24 and 48 during the study
To compare changes in ALT from baseline and the rate of hepatic cytolysis (ALT>5x ULN)
To compare suppression of HIV-1 RNA and changes in CD4/CD8 counts over 48 weeks
To compare the effect of therapy on histological changes in the liver and the presence of ccc-DNA

Enrollment:

24 patients in Clinical trial A (of whom 16 enter substudy A1).

Clinical Trial A:

Patients with HIV/HBV co-infection who are naive to HIV/HBV therapy, have detectable HBV viraemia and are willing to start antiretroviral therapy.

Inclusion Criteria:

Written informed consent
Documented HIV infection
Age 18 - 70 years
HBV DNA > 106 copies/ml

Randomization:

Arm 1: Zidovudine (AZT), emtricitabine (FTC), efavirenz (EFV)
Arm 2: Tenofovir (TDF), emtricitabine (FTC), efavirenz (EFV)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)

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
Age 18 - 70 years
HBV DNA > 10E6 copies/ml
ALT < 10 x ULN (upper limit of normal)

Key exclusion criteria (9 listed)

Hepatitis C viral RNA (CV-RNA) positive or Anti-hepatitis A virus immunoglobulin M (HAV IgM) positive
Acute hepatitis (serum ALT > 1000 U/L)
Prior LAM, TDF, or adefovir dipivoxil (ADV) therapy
Active opportunistic infection
Pregnancy or lactation

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	–
emtricitabine	Drug	–
zidovudine	Drug	–
efavirenz	Drug	–

Primary outcome

HBV DNA suppression as measured by comparison of area under the curve (AUC) measurements after 48 weeks therapy

6 secondary outcomes

Proportion of patients with undetectable HBV DNA in serum
Rate of hepatitis B e antigen (HBeAg) and hepatitis B surface antigen (HBsAg) seroconversion
Rate of emergence of lamivudine (LAM)-resistant HBV genotypes
Suppression of plasma HIV-RNA (< 50 copies/ml)
Changes in CD4+ /CD8+ cell counts
Presence of covalently closed circle DNA (cccDNA) on liver biopsy

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 24 Apr 2007.

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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.

Joep M.A. Lange, MD PhD study chair

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Kiat Ruxrungtham, MD PhD principal investigator

HIVNAT Bangkok

Jan Prins, MD PhD principal investigator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing tenofovir, emtricitabine and zidovudine in people with HIV Infections and Hepatitis B, run by International Antiviral Therapy Evaluation Center at 1 site in Netherlands.

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 24 Apr 2007. 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 Netherlands. 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?

HBV DNA suppression as measured by comparison of area under the curve (AUC) measurements after 48 weeks therapy. 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 NCT00127959.

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 24 Apr 2007.