Hepatitis C, ChronicPhase 4SAEI_IFN_1NCT00553930
Low Dose Peginterferon-α 2a for Chronic Hepatitis C, Genotypes 2 or 3, in HIV-coinfected Patients
A Phase 4 study testing Pegylated interferon alfa-2a and Ribavirin and Pegylated interferon alfa 2a and Ribavirin in people with Hepatitis C, Chronic and HIV Infections, run by Sociedad Andaluza de Enfermedades Infecciosas at 1 site in Spain.
Trial summary
Hypothesis: A regimen of low dose of peginterferon alfa-2a plus ribavirin may be as effective as currently recommended regimen for chronic hepatitis C in HIV-coinfected patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic, HIV Infections
- What is being tested?
- Pegylated interferon alfa-2a and Ribavirin and 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
- 71 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2007to May 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18 years
- HIV infected, diagnosed with chronic hepatitis or compensated cirrhosis by hepatitis C virus (both anti-HCV antibodies and HCV RNA levels detectable in serum) not previously treated.
- Women of child-bearing age: negative pregnancy test
- Ability to understand and sign a written consent form
Who cannot join
- Previous interferon treatment
- Pregnancy or breastfeeding
- Acute or chronic hepatitis B infection (positivity for hepatitis B surface antigen or plasma DNA)
- Creatinine clearance < 50 ml/min, according to Cockcroft-Gault
- Decompensated liver disease
- History of organ transplantation
Show all 11Show fewer
- Concomitant treatment with immunomodulators or didanosine
- Alcohol abuse or use of other recreational drugs
- History of severe psychiatric conditions
- Autoimmune diseases
- Inability to understand and sign a written consent form
Trial locations and contacts
1 site in 1 country.
Spain1 site
Infectious Diseases Service.Hospitales Universitarios Virgen del Rocio
Seville, Sevilla, 41013
About this study
Official title: Efficacy of Low Dose Pegylated Interferon-α 2a Plus Ribavirin for the Treatment of Chronic Hepatitis C, Genotypes 2 or 3, in HIV-coinfected Patients.
Hypothesis: A regimen of low dose of peginterferon alfa-2a plus ribavirin may be as effective as currently recommended regimen for chronic hepatitis C in HIV-coinfected patients.
Objective: To evaluate the efficacy of lower dose of pegylated interferon-α 2a (135 µg weekly) plus ribavirin and a shorter duration of treatment (20 weeks after achieving an undetectable plasmatic HCV-RNA)than the current recommended in patients with chronic hepatitis or compensated cirrhosis by hepatitis C virus, genotypes 2 or 3, in HIV-coinfected patients in real use conditions.
Method: Phase IV, postautorization, open labelled multicenter trial with a planned duration of 118 weeks in which 71 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 wall 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.
- Conditions
- Hepatitis C, Chronic, HIV Infections
- Being tested
- Pegylated interferon alfa-2a and Ribavirin, Pegylated interferon alfa 2a and Ribavirin
- Keywords
- HCV/HIV-coinfected patients, Peginterferon alfa-2a
- Medical subject headings
- Hepatitis C, Chronic, 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
All patients will be treated with the combination of pegIFN-α 2a (135 μg per week)plus oral Ribavirin at a dose of 800 mg per day. The treatment will be continued up to 20 weeks after reaching an undetectable plasma RNA-HCV. Treatment will be discontinued for patients who did not achieve a reduction of al least 2 log10 IU/ml in plasma HCV RNA levels with respect to baseline at week 12 and will be considered as viral failures.
Pegylated interferon alfa 2a and RibavirinDrug
Also called Pegasis (TM), Copegus (TM)
Pegylated interferon alfa 2a (135 ug/week)and Ribavirin (800 mg/day). Duration: 20 weeks after reaching an undetectable plasma RNA_HCV. Treatment will be discontinued for patients who did not achieve a decrease of >= 2 log10 IU/ml in plasma HCV RNA levels with respect to baseline at week 12 of treatment or earlier and will be considered as viral failures.
| Study group | Role | What they receive |
|---|---|---|
| G 2/3 | Experimental | Patients with chronic hepatitis or compensated cirrhosis by hepatitis C virus, genotypes 2 or 3, and HIV-coinfected. Receives: Drug: Pegylated interferon alfa-2a and Ribavirin; 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: 24 weeks after the cessation of treatment
Secondary outcomes (1)
Relationships between the plasma interferon an ribavirin concentrations and efficacy. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.
Measured: Throughout treatment and 24 weeks after finishing it
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sociedad Andaluza de Enfermedades Infecciosas
- Sponsor type
- Research network
- Investigators
- Luis F Lopez-Cortes, MD, PhD, Study director, Infectious Disease Service. Hospitales Universitarios Virgen del Rocio. Sevilla. SpainAntonio Rivero, MD, PhD, Principal investigator, Hospital Universitario Reina Sofía. Córdoba. SpainMercedes Gonzalez, MD, PhD, Principal investigator, Hospital Universitario Virgen de la Victoria. Malaga. SpainAngel Garcia, MD, Principal investigator, Hospital Universitario de Valme. Sevilla. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553930
- Sponsor's protocol ID
- SAEI_IFN_1
- Acronym
- SAEI_IFN_1
- Status last verified
- May 2010
- First submitted
- 3 Nov 2007
- Last updated
- 18 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lopez-Cortes LF, Ruiz-Valderas R, Jimenez-Jimenez L, Gonzalez-Escribano MF, Torres-Cornejo A, Mata R, Rivero A, Pineda JA, Marquez-Solero M, Viciana P; Grupo para el Estudio de las Hepatitis Viricas (HEPAVIR) de la Sociedad Andaluza de Enfermedades Infecciosas. Influence of IL28B polymorphisms on response to a lower-than-standard dose peg-IFN-alpha 2a for genotype 3 chronic hepatitis C in HIV-coinfected patients. PLoS One. 2012;7(1):e28115. doi: 10.1371/journal.pone.0028115. Epub 2012 Jan 3.
PubMed 22235243
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low Dose Pegylated Interferon-α 2a Plus Ribavirin for the Treatment of Chronic Hepatitis C, Genotypes 2 or 3, in HIV-coinfected Patients.
- ClinicalTrials.gov ID
- NCT00553930
- Acronym / sponsor ID
- SAEI_IFN_1 / SAEI_IFN_1
- Conditions
- Hepatitis C, Chronic, HIV Infections
- Keywords
- HCV/HIV-coinfected patients, Peginterferon alfa-2a
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Sociedad Andaluza de Enfermedades InfecciosasResearch network
- Study start
- Nov 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 6 Nov 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.
Hypothesis: A regimen of low dose of peginterferon alfa-2a plus ribavirin may be as effective as currently recommended regimen for chronic hepatitis C in HIV-coinfected patients.
Objective: To evaluate the efficacy of lower dose of pegylated interferon-α 2a (135 µg weekly) plus ribavirin and a shorter duration of treatment (20 weeks after achieving an undetectable plasmatic HCV-RNA)than the current recommended in patients with chronic hepatitis or compensated cirrhosis by hepatitis C virus, genotypes 2 or 3, in HIV-coinfected patients in real use conditions.
Method: Phase IV, postautorization, open labelled multicenter trial with a planned duration of 118 weeks in which 71 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 wall 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| G 2/3 | Experimental | Drug: Pegylated interferon alfa-2a and Ribavirin, Drug: Pegylated interferon alfa 2a and RibavirinPatients with chronic hepatitis or compensated cirrhosis by hepatitis C virus, genotypes 2 or 3, and HIV-coinfected. |
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, diagnosed with chronic hepatitis or compensated cirrhosis by hepatitis C virus (both anti-HCV antibodies and HCV RNA levels detectable in serum) not previously treated.
- Women of child-bearing age: negative pregnancy test
- Ability to understand and sign a written consent form
Key exclusion criteria (11 listed)
- Previous interferon treatment
- Pregnancy or breastfeeding
- Acute or chronic hepatitis B infection (positivity for hepatitis B surface antigen or plasma DNA)
- Creatinine clearance < 50 ml/min, according to Cockcroft-Gault
- Decompensated liver disease
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, CopegusAll patients will be treated with the combination of pegIFN-α 2a (135 μg per week)plus oral Ribavirin at a dose of 800 mg per day. The treatment will be continued up to 20 weeks after reaching an undetectable plasma RNA-HCV. Treatment will be discontinued for patients who did not achieve a reduction of al least 2 log10 IU/ml in plasma HCV RNA levels with respect to baseline at week 12 and will be considered as viral failures. | Drug | G 2/3 |
| Pegylated interferon alfa 2a and RibavirinAlso: Pegasis (TM), Copegus (TM)Pegylated interferon alfa 2a (135 ug/week)and Ribavirin (800 mg/day). Duration: 20 weeks after reaching an undetectable plasma RNA_HCV. Treatment will be discontinued for patients who did not achieve a decrease of >= 2 log10 IU/ml in plasma HCV RNA levels with respect to baseline at week 12 of treatment or earlier and will be considered as viral failures. | Drug | G 2/3 |
Primary outcome
Sustained viral response(undetectable serum HCV-RNA)
Time frame: 24 weeks after the cessation of treatment
1 secondary outcome
Relationships between the plasma interferon an ribavirin concentrations and efficacy. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.
Time frame: Throughout treatment and 24 weeks after finishing it
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 18 May 2010.
- Derived from this study: PubMed 22235243Lopez-Cortes LF, Ruiz-Valderas R, Jimenez-Jimenez L, Gonzalez-Escribano MF, Torres-Cornejo A, Mata R, Rivero A, Pineda JA, Marquez-Solero M, Viciana P; Grupo para el Estudio de las Hepatitis Viricas (HEPAVIR) de la Sociedad Andaluza de Enfermedades Infecciosas. Influence of IL28B polymorphisms on response to a lower-than-standard dose peg-IFN-alpha 2a for genotype 3 chronic hepatitis C in HIV-coinfected patients. PLoS One. 2012;7(1):e28115. doi: 10.1371/journal.pone.0028115. Epub 2012 Jan 3.
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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
Infectious Disease Service. Hospitales Universitarios Virgen del Rocio. Sevilla. Spain
Antonio Rivero, MD, PhD principal investigator
Hospital Universitario Reina Sofía. Córdoba. Spain
Mercedes Gonzalez, MD, PhD principal investigator
Hospital Universitario Virgen de la Victoria. Malaga. Spain
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 Pegylated interferon alfa-2a and Ribavirin and Pegylated interferon alfa 2a and Ribavirin in people with Hepatitis C, Chronic and HIV Infections, run by Sociedad Andaluza de Enfermedades Infecciosas at 1 site 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 11 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 18 May 2010. 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 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 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?
Sustained viral response(undetectable serum HCV-RNA) (time frame: 24 weeks after the cessation of treatment). 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 NCT00553930, which also lists 1 linked publication.
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 18 May 2010.