Hepatitis BPhase 2/3HB01EMVIPEGNCT00391638

Efficacy and Tolerance of Peg-interferon Alpha 2a Added to Tenofovir and Emtricitabine in AgHBe Positive HBV-HIV Co-infected Patients

A Phase 2/3 study testing TRUVADA (EMTRICITABINE + TENOFOVIR DF) and PEGASYS 180μg (Interféron pégylé alpha -2a) in people with Hepatitis B and HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis at 2 sites in France.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis B, HIV Infections
What is being tested?: TRUVADA (EMTRICITABINE + TENOFOVIR DF) and PEGASYS 180μg (Interféron pégylé alpha -2a)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 2 sitesFrance
Study dates: Jan 2007to Oct 2012
Phase: Phase 2/3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

HIV infection
Karnofsky above 80 per cent
Stable ARV since 4 months
CD4 above 200 per mm3
ARN VIH below 10000 copies per ml
hepatitis B chronic with : positive antigenaemia HBe and negative antiHBe, positive DNA HBV before or under tenofovir treatment, DNA HBV negative or below 10000 copies per ml at W-8.
Previous treatment by tenofovir and lamivudine or emtricitabine more than 6 months

Who cannot join

HIV 2 infection
Hepatitis C or D
Opportunistic infection
Alcool consummation more than 50g/d
Cirrhosis
Pregnancy or plan of pregnancy

Show all 12Show fewer

Breastfeeding
Immunosuppressive or modulating of the immune response treatment
Other Hepatitis B treatments than tenofovir, lamivudine or emtricitabine since 6 months
Malabsorption
Exclusive HIV therapy with Truvada
Evolutive cancer under chemotherapy

Trial locations and contacts

2 sites in 1 country.

France2 sites

Service des Maladies Infectieuses CHU
Dijon, 21079
Service d'Hépato-Gastroentérologie Hopital Hôtel-Dieu
Lyon, 69288

Other trials in France

About this study

Official title: Pilot Study on Efficacy and Tolerance of Peg-interferon Alpha-2a (Pegasys) Added to Tenofovir DF and Emtricitabine (Truvada) in AGHBe Positive HBV-HIV Co-infected Patients. ANRS HB 01 EMVIPEG.

HBe seroconversion is an important goal for anti-HBV treatment, since it is associated with a non progressive liver infection and a better clinical outcome. However, the rate of HBe seroconversion is low in HIV-HBV co-infected patients, mostly treated by tenofovir and emtricitabine. This study will evaluate the efficacy and the safety of a one-year Peg-interferon alpha 2a additional treatment in patients already treated by tenofovir and emtricitabine without reaching HBe seroconversion.

Read the detailed description

Many HBV-HIV co-infected patients are currently treated with dual activity drugs such as tenofovir and emtricitabine, often in combination. However, despite the potent antiviral activity of these drugs, the rate of HBe seroconversion is quite low, and not always sustained over time. HBe seroconversion is an important goal for anti-HBV treatment, since it is associated with a non progressive liver infection and a better clinical outcome. On the other hand, treatments with antiviral and immuno-modulator activity such as Peg-interferon, are infrequently used in co-infected patients, despite promising data in the field of HBV mono-infection with increased rates and sustained HBe seroconversions. This pilot study will evaluate the efficacy and the safety of a one-year Peg-interferon alpha 2a additional treatment (180 micro-g once a week, by injection), in 55 patients already treated by tenofovir and emtricitabine for at least 6 months, and who did not reached HBe seroconversion

Conditions: Hepatitis B, HIV Infections
Being tested: TRUVADA (EMTRICITABINE + TENOFOVIR DF), PEGASYS 180μg (Interféron pégylé alpha -2a)
Keywords: HIV and Hepatitis B coinfection, Peg interferon, tenofovir, emtricitabine, Hepatitis B e Antigens, Treatment Experienced
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.

TRUVADA (EMTRICITABINE + TENOFOVIR DF)Drug
Truvada ® (200 mg tablet of 300 mg of emtricitabine + tenofovir DF) Dosage 1 tablet taken orally once a day
PEGASYS 180μg (Interféron pégylé alpha -2a)Biological
Pegasys ® injection 180μg Dosage: A subcutaneous injection per week

Study groups in NCT00391638
Study group	Role	What they receive
HIV antiretroviral therapy, TRUVADA , PEGASYS 180μg	Experimental	Week-8 up Week0: HIV antiretroviral therapy Week 0 up Week 48: HIV antiretroviral therapy + TRUVADA + PEGASYS 180μg Week 48 up Week 72: HIV antiretroviral therapy + TRUVADA Week 72 up Week 144: HIV antiretroviral therapy Receives: Drug: TRUVADA (EMTRICITABINE + TENOFOVIR DF); Biological: PEGASYS 180μg (Interféron pégylé alpha -2a)

What is being measured

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

proportion of patients with seroconversion HBe (loose of HBe antigen and acquisition of HBe antibody) and HBV DNA below 2.3 log10 copies per ml
Measured: at Week 72

Secondary outcomes (13)

proportion of patients with negative HBe antigen.
Measured: at Week 72 and Week 144
proportion of patients with HBV DNA under 2.3 log 10 copies per ml.
Measured: at Week 72 and Week 144
proportion of seroconversion HBs.
Measured: at Week 72 and Week 144
proportion of patients with no more HBs antigen.
Measured: at Week 72 and Week 144
proportion of patients with HBV DNA below 2.3 log 10 copies per ml in relation with 3TC resistance or not before tenofovir treatment; increased of ALT before tenofovir treatment;duration of tenofovir treatment before study.
Measured: before tenofovir treatment, duration of tenofovir treatment before study
Biological evolution and histological of hepatic activity and fibrosis.
Measured: at day 0 and Week 72
Biochemical response (ALT at normal value).
Measured: at Week 72 and Week 144
proportion of patients with :seroconversion HBe and HBV DNA below 2.3 log 10 copies per ml
Measured: at Week 48
HBV and HIV resistance mutations to tenofovir DF and Emtricitabine.
Measured: at Week 72
Immunological and virological evolution of HIV infection.
Measured: between Day 0 and Week 144
Safety
Measured: between Day 0 and Week 144
Quality of life
Measured: Day 0, Week 12, Week 24, Week 48, Week 72
Treatment adherence
Measured: Day 0 to Week 144

Timeline

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

Jan 2007Oct 2012

First posted24 Oct 2006 (estimated)
Study startJan 2007
Primary completionMay 2011
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatitis BStudies 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 2/3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00391638
Sponsor's protocol ID: 2006-004137-15
Other IDs: ANRS HB 01 EMVIPEG
Acronym: HB01EMVIPEG
Status last verified: Jan 2015
First submitted: 23 Oct 2006
Last updated: 15 Jan 2015
Results posted: No
Data monitoring committee: Yes

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?

See locations

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
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Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
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Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
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All Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study on Efficacy and Tolerance of Peg-interferon Alpha-2a (Pegasys) Added to Tenofovir DF and Emtricitabine (Truvada) in AGHBe Positive HBV-HIV Co-infected Patients. ANRS HB 01 EMVIPEG.
ClinicalTrials.gov ID: NCT00391638
Acronym / sponsor ID: HB01EMVIPEG / 2006-004137-15
Conditions: Hepatitis B, HIV Infections
Keywords: HIV and Hepatitis B coinfection, Peg interferon, tenofovir, emtricitabine, Hepatitis B e Antigens, Treatment Experienced
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: French National Agency for Research on AIDS and Viral HepatitisOther government
Collaborators: Gilead Sciences, Roche Pharma AG
Study start: Jan 2007
Primary completion: May 2011 (actual)
Study completion: Oct 2012 (actual)
First posted: 24 Oct 2006 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
HIV antiretroviral therapy, TRUVADA , PEGASYS 180μg	Experimental	Drug: TRUVADA (EMTRICITABINE + TENOFOVIR DF), Biological: PEGASYS 180μg (Interféron pégylé alpha -2a)Week-8 up Week0: HIV antiretroviral therapy Week 0 up Week 48: HIV antiretroviral therapy + TRUVADA + PEGASYS 180μg Week 48 up Week 72: HIV antiretroviral therapy + TRUVADA Week 72 up Week 144: HIV antiretroviral therapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

HIV infection
Karnofsky above 80 per cent
Stable ARV since 4 months
CD4 above 200 per mm3
ARN VIH below 10000 copies per ml

Key exclusion criteria (12 listed)

HIV 2 infection
Hepatitis C or D
Opportunistic infection
Alcool consummation more than 50g/d
Cirrhosis

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
TRUVADA (EMTRICITABINE + TENOFOVIR DF)Truvada ® (200 mg tablet of 300 mg of emtricitabine + tenofovir DF) Dosage 1 tablet taken orally once a day	Drug	HIV antiretroviral therapy, TRUVADA , PEGASYS 180μg
PEGASYS 180μg (Interféron pégylé alpha -2a)Pegasys ® injection 180μg Dosage: A subcutaneous injection per week	Biological	HIV antiretroviral therapy, TRUVADA , PEGASYS 180μg

Primary outcome

proportion of patients with seroconversion HBe (loose of HBe antigen and acquisition of HBe antibody) and HBV DNA below 2.3 log10 copies per ml
Time frame: at Week 72

13 secondary outcomes

proportion of patients with negative HBe antigen.
Time frame: at Week 72 and Week 144
proportion of patients with HBV DNA under 2.3 log 10 copies per ml.
Time frame: at Week 72 and Week 144
proportion of seroconversion HBs.
Time frame: at Week 72 and Week 144
proportion of patients with no more HBs antigen.
Time frame: at Week 72 and Week 144
proportion of patients with HBV DNA below 2.3 log 10 copies per ml in relation with 3TC resistance or not before tenofovir treatment; increased of ALT before tenofovir treatment;duration of tenofovir treatment before study.
Time frame: before tenofovir treatment, duration of tenofovir treatment before study
Biological evolution and histological of hepatic activity and fibrosis.
Time frame: at day 0 and Week 72
Biochemical response (ALT at normal value).
Time frame: at Week 72 and Week 144
proportion of patients with :seroconversion HBe and HBV DNA below 2.3 log 10 copies per ml
Time frame: at Week 48
HBV and HIV resistance mutations to tenofovir DF and Emtricitabine.
Time frame: at Week 72
Immunological and virological evolution of HIV infection.
Time frame: between Day 0 and Week 144
Safety
Time frame: between Day 0 and Week 144
Quality of life
Time frame: Day 0, Week 12, Week 24, Week 48, Week 72
Treatment adherence
Time frame: Day 0 to Week 144

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 15 Jan 2015.

Related trials for Hepatitis B

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
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Active, not recruitingPhase 2
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Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
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Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

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.

Lionel Piroth, MD principal investigator

Centre Hospitalier Universitaire Dijon

Fabrice Carrat, MD study chair

Inserm U 707 Paris France

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

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 12 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 15 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

proportion of patients with seroconversion HBe (loose of HBe antigen and acquisition of HBe antibody) and HBV DNA below 2.3 log10 copies per ml (time frame: at Week 72). 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 NCT00391638.

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 15 Jan 2015.