Liver CirrhosisPhase 2/3NCT01006031
Retreatment With High Doses of pegIFN Alfa-2a and Ribavirin of Previous Nonresponders HIV-coinfected Patients With Cirrhosis Due to HCV 1-4
A Phase 2/3 study testing Pegylated interferon alfa-2a and Ribavirin in people with Liver Cirrhosis and Hepatitis C Virus, run by Sociedad Andaluza de Enfermedades Infecciosas at 4 sites in Spain.
Trial summary
Objective: To evaluate the efficacy and safety of high doses of both peginterferon-alfa 2a (360 ug per week) plus ribavirin (800 mg b.i.d.) in HIV-infected patients with compensated liver cirrhosis by HCV genotype 1 or 4 without previous virological response(*) to a standard dose treatment of both drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Hepatitis C Virus, HIV Infection
- What is being tested?
- Pegylated interferon alfa-2a and Ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesSpain
- Study dates
- Oct 2009to Dec 2011
- 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
- Age older than 18 years
- HIV-infected patients with compensated liver cirrhosis by HCV genotype 1 or 4 without previous virological response(*) to a standard dose treatment of both drugs.
- Women of child-bearing age: negative pregnancy test
- Ability to understand and sign a written consent form
Who cannot join
- HCV genotypes different to 1 or 4
- Acute or chronic hepatitis B infection (positivity for hepatitis B surface antigen or plasma DNA) or other concomitant causes of liver disease
- Pregnancy or breast feeding.
- Decompensated liver disease at baseline.
- Neutropenia <1000/uL, anemia <100 g/L or thrombocytopenia <20.000/uL.
- Creatinine clearance < 50 mL/min.
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- Concomitant treatment with immunomodulators or zidovudine, didanosine or stavudine.
- Organ or bone marrow transplantation
- Current alcoholism or iv drug abuse. Methadone is allowed.
- Current neoplasm and/or anti-tumor chemotherapy or immunomodulators
- Psychosis or uncontrolled clinical depression
- Auto-immune disease, including auto-immune hepatitis
- History of significant cardiovascular disease (NYHA III-IV) including but not limited to uncontrolled hypertension, angina pectoris, myocardial infarction, coronary artery surgery and congestive heart failure.
- Thyroid dysfunction.
- Clinically significant retinal abnormalities
- Inability to understand and sign a written consent form
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Universitario Reina Sofía
Córdoba
Hospitales Universitarios Virgen del Rocío
Seviila
Hospital Universitario de Valme
Seville
Hospital Universitario Virgen Macarena
Seville
About this study
Official title: Efficacy of High Doses of Both Pegylated Interferon Alfa-2a and Ribavirin for Retreatment of HIV-coinfected Patients With Liver Cirrhosis Due to HCV Genotype 1 or 4 Nonresponders to Previous Standard Therapy.
Objective: To evaluate the efficacy and safety of high doses of both peginterferon-alfa 2a (360 ug per week) plus ribavirin (800 mg b.i.d.) in HIV-infected patients with compensated liver cirrhosis by HCV genotype 1 or 4 without previous virological response(*) to a standard dose treatment of both drugs.
(*) Non previous virological response: no decrease of plasma RNA-HCV at least 2 log10 after 12 weeks in treatment or breakthrough viremia while on treatment.
Read more
Additionally, this study will evaluated the influence of simultaneous peginterferon-alfa 2a and ribavirin plasma concentrations on early viral response (EVR) and sustained viral response (SVR) in these patients.
Method: Pilot clinical trial, phase II-III, open labeled multicenter in which patients from several hospitals of the Servicio Andaluz de Salud will be enrolled.
The usual clinical and analytical follow up will be performed but additional blood samples will be obtained for determination of interferon and ribavirin plasma levels. The primary end point will be a sustained virologic response (defined as an undetectable serum HCV-RNA after 24 weeks after the cessation of treatment). Likewise, rapid virological response (at 4 weeks of treatment), early virological response (at 12 weeks), and end of treatment response rates will be evaluated as well as their relationships with the plasma interferon an ribavirin concentrations determined by ELISA and HPLC, respectively. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results. The evolution of liver fibrosis will be evaluated comparing the basal and end of treatment results of transient elastometry.
- Conditions
- Liver Cirrhosis, Hepatitis C Virus, HIV Infection
- Being tested
- Pegylated interferon alfa-2a and Ribavirin
- Keywords
- Liver cirrhosis, Hepatitis C virus, HIV infection, Pegylated interferon alfa-2a, Ribavirin, Treatment experienced
- Medical subject headings
- Liver Cirrhosis, Hepatitis C, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated interferon alfa-2a and RibavirinDrug
Also called Pegasys, Copegus
Pegylated interferon alfa-2a (360 ug per week) plus oral Ribavirin (800 mg b.i.d.) for 48 or 72 weeks. The treatment will be discontinued for patients who did not achieve a reduction with respect to baseline of at least 0.5 log10 IU/ml in plasma RNA-HCV levels at week 4 or 2 log10 UI/ml at week 12 and will be considered as viral failures.
Duration: 48 weeks for patients reaching an undetectable plasma RNA_HCV at week12 and 72 weeks for those without a negative viremia at week 12 but a reduction of at least 2 log10 IU/ml in RNA-HCV levels.
| Study group | Role | What they receive |
|---|---|---|
| PegIFN alfa-2a and Ribavirin | Experimental | HIV-coinfected patients with compensated cirrhosis by hepatitis C virus, genotype 1 or 4. Receives: Drug: Pegylated interferon alfa-2a and Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained viral response (undetectable serum HCV-RNA)
Measured: Throughout treatment and 24 weeks after finishing it
Secondary outcomes (3)
Relationships between the plasma interferon an ribavirin concentrations and efficacy
Measured: Throughout treatment and 24 weeks after finishing it.
safety and tolerability of the studied medications
Measured: Throughout treatment and 24 weeks after finishing it
The evolution of liver fibrosis will be evaluated comparing the basal and end of treatment results of transient elastometry
Measured: baseline and after finishing treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Andaluza de Enfermedades Infecciosas
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Antonio Rivero, Sociedad Andaluza de Enfermedades Infecciosas
- Investigators
- Luis F Lopez-Cortes, MD, PhD, Study director, Instituto de Biomedicina de Sevilla. Hospitales Universitarios Virgen del RocíoLuis F Lopez-Cortes, MD, PhD, Principal investigator, Instituto de Biomedicina de Sevilla. Hospitales Universitarios Virgen del RocioAntonio Rivero, MD, PhD, Principal investigator, Hospital Universitario Reina Sofia. CordobaMª Jose Rios-Villegas, MD, PhD, Principal investigator, Hospital Universitario Viren MAcarena. SevillaJuan A. Pineda, MD, PhD, Principal investigator, Hospital Universitario de Valme. Sevilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006031
- Sponsor's protocol ID
- HEPAVIR_IFN_2009
- Status last verified
- Dec 2011
- First submitted
- 29 Oct 2009
- Last updated
- 30 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High Doses of Both Pegylated Interferon Alfa-2a and Ribavirin for Retreatment of HIV-coinfected Patients With Liver Cirrhosis Due to HCV Genotype 1 or 4 Nonresponders to Previous Standard Therapy.
- ClinicalTrials.gov ID
- NCT01006031
- Acronym / sponsor ID
- HEPAVIR_IFN_2009
- Conditions
- Liver Cirrhosis, Hepatitis C Virus, HIV Infection
- Keywords
- Liver cirrhosis, Hepatitis C virus, HIV infection, Pegylated interferon alfa-2a, Ribavirin, Treatment experienced
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sociedad Andaluza de Enfermedades InfecciosasResearch network
- Study start
- Oct 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Nov 2009 (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.
Objective: To evaluate the efficacy and safety of high doses of both peginterferon-alfa 2a (360 ug per week) plus ribavirin (800 mg b.i.d.) in HIV-infected patients with compensated liver cirrhosis by HCV genotype 1 or 4 without previous virological response(*) to a standard dose treatment of both drugs.
(*) Non previous virological response: no decrease of plasma RNA-HCV at least 2 log10 after 12 weeks in treatment or breakthrough viremia while on treatment.
Additionally, this study will evaluated the influence of simultaneous peginterferon-alfa 2a and ribavirin plasma concentrations on early viral response (EVR) and sustained viral response (SVR) in these patients.
Method: Pilot clinical trial, phase II-III, open labeled multicenter in which patients from several hospitals of the Servicio Andaluz de Salud will be enrolled.
The usual clinical and analytical follow up will be performed but additional blood samples will be obtained for determination of interferon and ribavirin plasma levels. The primary end point will be a sustained virologic response (defined as an undetectable serum HCV-RNA after 24 weeks after the cessation of treatment). Likewise, rapid virological response (at 4 weeks of treatment), early virological response (at 12 weeks), and end of treatment response rates will be evaluated as well as their relationships with the plasma interferon an ribavirin concentrations determined by ELISA and HPLC, respectively. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results. The evolution of liver fibrosis will be evaluated comparing the basal and end of treatment results of transient elastometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PegIFN alfa-2a and Ribavirin | Experimental | Drug: Pegylated interferon alfa-2a and RibavirinHIV-coinfected patients with compensated cirrhosis by hepatitis C virus, genotype 1 or 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age older than 18 years
- HIV-infected patients with compensated liver cirrhosis by HCV genotype 1 or 4 without previous virological response(*) to a standard dose treatment of both drugs.
- Women of child-bearing age: negative pregnancy test
- Ability to understand and sign a written consent form
Key exclusion criteria (16 listed)
- HCV genotypes different to 1 or 4
- Acute or chronic hepatitis B infection (positivity for hepatitis B surface antigen or plasma DNA) or other concomitant causes of liver disease
- Pregnancy or breast feeding.
- Decompensated liver disease at baseline.
- Neutropenia <1000/uL, anemia <100 g/L or thrombocytopenia <20.000/uL.
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 |
|---|---|---|
| Pegylated interferon alfa-2a and RibavirinAlso: Pegasys, CopegusPegylated interferon alfa-2a (360 ug per week) plus oral Ribavirin (800 mg b.i.d.) for 48 or 72 weeks. The treatment will be discontinued for patients who did not achieve a reduction with respect to baseline of at least 0.5 log10 IU/ml in plasma RNA-HCV levels at week 4 or 2 log10 UI/ml at week 12 and will be considered as viral failures. Duration: 48 weeks for patients reaching an undetectable plasma RNA_HCV at week12 and 72 weeks for those without a negative viremia at week 12 but a reduction of at least 2 log10 IU/ml in RNA-HCV levels. | Drug | PegIFN alfa-2a and Ribavirin |
Primary outcome
Sustained viral response (undetectable serum HCV-RNA)
Time frame: Throughout treatment and 24 weeks after finishing it
3 secondary outcomes
Relationships between the plasma interferon an ribavirin concentrations and efficacy
Time frame: Throughout treatment and 24 weeks after finishing it.
safety and tolerability of the studied medications
Time frame: Throughout treatment and 24 weeks after finishing it
The evolution of liver fibrosis will be evaluated comparing the basal and end of treatment results of transient elastometry
Time frame: baseline and after finishing treatment
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 30 Dec 2011.
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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.
Luis F Lopez-Cortes, MD, PhD study director
Instituto de Biomedicina de Sevilla. Hospitales Universitarios Virgen del Rocío
Luis F Lopez-Cortes, MD, PhD principal investigator
Instituto de Biomedicina de Sevilla. Hospitales Universitarios Virgen del Rocio
Antonio Rivero, MD, PhD principal investigator
Hospital Universitario Reina Sofia. Cordoba
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pegylated interferon alfa-2a and Ribavirin in people with Liver Cirrhosis and Hepatitis C Virus, run by Sociedad Andaluza de Enfermedades Infecciosas at 4 sites in Spain.
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 4 inclusion and 16 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 30 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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?
Sustained viral response (undetectable serum HCV-RNA) (time frame: Throughout treatment and 24 weeks after finishing it). 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 30 Dec 2011.