HIV InfectionsPhase 4NCT00356486
Viral Kinetics of Treatment With Peginterferon Alpha-2a, Ribavirin and Epoetin β in Patients Coinfected HCV/HIV
A Phase 4 study testing Peginterferon alfa-2a, Ribavirin, epoetin-β and Peginterferon alfa-2a + Ribavirin for 12 weeks in people with HIV Infections, run by Germans Trias i Pujol Hospital at 12 sites in Spain.
Trial summary
The purpose of this study is to compare the early virological response (EVR = undetectable [ribonucleic acid-hepatitis C virus] RNA-HCV or a reduction of > 2 log10) of patients with chronic hepatitis C coinfected with HIV treated with induction doses of peginterferon alpha-2a (40 KD) 270 µg/week and ribavirin 1600… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Peginterferon alfa-2a, Ribavirin, epoetin-β and Peginterferon alfa-2a + Ribavirin for 12 weeks
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 12 sitesSpain
- Study dates
- Oct 2005to Mar 2009
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serological evidence of chronic hepatitis C infection in an anti-HCV antibody test
- Detectable RNA-HCV plasma level genotype 1 and 4
- ALT serum activity above the upper limit of normality
- Chronic liver disease consistent with chronic hepatitis C infection in a biopsy obtained during the two years prior to inclusion in the study
- Serological evidence of HIV-1 infection, diagnosed by Enzyme-Linked Immunosorbent Assay (ELISA) and confirmed by Western-blot.
- Patients with CD4 cell count > 200 /µl
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- Stable status in HIV-1 infection, in the investigator's opinion, in other words, patients that are not expected to progress during the study.
- Patients treated with stable anti-retroviral therapy (HAART), which does not include nucleoside analogues, for at least 6 weeks before the baseline assessment
- Patients that do not receive HAART therapy
- Negative pregnancy test in urine or blood
Who cannot join
- Women currently pregnant or in the lactation period.
- Patients whose companion is pregnant.
- Therapy with interferon (IFN) or ribavirin at any previous time.
- Patients with cirrhosis in the hepatic biopsy.
- Documented suspicion by ultrasound of hepatocarcinoma.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Hospital General Universitario de Alicante
Alicante, 46014
Hospital Germans Trias i Pujol, Badalona
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, 08003
Hospital Clínic i Provincial
Barcelona, 08036
Hospital Puerta del Mar
Cadiz, 11009
Hospital Gregorio Marañón.
Madrid, 28007
Hospital Ramón y Cajal
Madrid, 28007
Hospital Clínico San Carlos
Madrid, 28040
Hospital La Paz
Madrid, 28046
Hospital de Donostia
San Sebastián, Donostia, 20012
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08221
Hospital General de Vic
Vic, Barcelona, 08500
About this study
Official title: Open, Multicentre and Randomised Phase IV Study to Evaluate Viral Kinetics in the First 12 Weeks of Patients With Chronic Hepatitis C Genotypes 1 and 4 Coinfected by the Human Immunodeficiency Virus Treated With Induction Doses of Peginterferon Alpha-2a (40 KD) (270 μg/Week) and Ribavirin (1600 mg/Day) With Epoetin β Support (450 IU/kg/Week)
The purpose of this study is to compare the early virological response (EVR = undetectable [ribonucleic acid-hepatitis C virus] RNA-HCV or a reduction of > 2 log10) of patients with chronic hepatitis C coinfected with HIV treated with induction doses of peginterferon alpha-2a (40 KD) 270 µg/week and ribavirin 1600 mg/day for 4 weeks, followed by 8 weeks of treatment with peginterferon alpha-2a (40 KD) 180 µg/week and ribavirin 1000-1200 mg/day versus treatment with peginterferon alpha-2a (40 KD) 180 µg/week and ribavirin 1000-1200 mg/day for 12 weeks.
Read the detailed description
This study seeks to ascertain whether treatment with higher doses of PEGASYS (270 µg/week) and ribavirin (1600 mg/day) for the first four weeks achieves the plasma concentrations of the product in the blood needed to reduce the half-life of the virions and accelerate the elimination thereof. This would bring the viral kinetic curves in coinfected patients closer to the model described for mono-infected HCV patients, probably achieving improved rates of response in week 12 (early virological response) and posterior in week 72 (sustained virological response).
Therefore, the patients were randomised to treatment with two different doses, 270 µg and 180 µg of PEGASYS, and 1600 mg and 1000-1200 mg of ribavirin.
- Conditions
- HIV Infections
- Being tested
- Peginterferon alfa-2a, Ribavirin, epoetin-β, Peginterferon alfa-2a + Ribavirin for 12 weeks
- Keywords
- Chronic Hepatitis C, Co-infection, Induction dose, HIV, HIV Infections
- Medical subject headings
- HIV Infections, Hepatitis C, Chronic, Coinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2a, Ribavirin, epoetin-βDrug
Peginterferon alfa-2a(270 µg/week) + Ribavirin (1600 mg/day) + epoetin-β (450 UI/kg/week) for 4 weeks. Peginterferon alfa-2a (180 µg/week) + Ribavirin(1000-1200 mg/day) for 8 weeks
Peginterferon alfa-2a + Ribavirin for 12 weeksDrug
Peginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Peginterferon alfa-2a (40 KD) (270 µg/week) + Ribavirin (1600 mg/day) + epoetin-β (450 UI/kg/week) for 4 weeks. Peginterferon alfa-2a (40 KD) (180 µg/week) + Ribavirin (1000-1200 mg/day) for 8 weeks Receives: Drug: Peginterferon alfa-2a, Ribavirin, epoetin-β |
| B | Experimental | Peginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks Receives: Drug: Peginterferon alfa-2a + Ribavirin for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with undetectable RNA-HCV
Measured: at week 12 after starting treatment
Secondary outcomes (8)
Variations of the levels of RNA-HCV
Measured: from baseline until weeks 4, 8, and 12 of the study
Percentage of patients with undetectable HCV RNA
Measured: in weeks 4 and 8 of the study
Levels of ALT
Measured: At weeks 4, 8, and 12
Percentage of patients that must reduce the dose of peginterferon alpha-2a (40 KD) and ribavirin.
Measured: During the 12 weeks of follow-up
Percentage of patients that drop out of the study for adverse effects or intolerance
Measured: During the 12 weeks of follow-up
Variations in levels of haemoglobin, neutrophil, and platelet count
Measured: at 4, 8, and 12 weeks with regard to baseline
AIDS-defining events or death
Measured: During the 12 weeks of follow-up
Changes in the CD4/CD8 cell count
Measured: At 4, 8, and 12 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2006 (estimated)
- Study startOct 2005
- Primary completionMar 2009
- Study completionMar 2009
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Responsible party
- Sponsor
- Investigators
- Bonaventura Clotet, MD, PhD, Principal investigator, LLuita contra la Sida Foundation-HIV Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356486
- Sponsor's protocol ID
- CORAL-2
- Other IDs
- 2004 - 000907 -16, 2004
- Status last verified
- Dec 2019
- First submitted
- 25 Jul 2006
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Multicentre and Randomised Phase IV Study to Evaluate Viral Kinetics in the First 12 Weeks of Patients With Chronic Hepatitis C Genotypes 1 and 4 Coinfected by the Human Immunodeficiency Virus Treated With Induction Doses of Peginterferon Alpha-2a (40 KD) (270 μg/Week) and Ribavirin (1600 mg/Day) With Epoetin β Support (450 IU/kg/Week)
- ClinicalTrials.gov ID
- NCT00356486
- Acronym / sponsor ID
- CORAL-2
- Conditions
- HIV Infections
- Keywords
- Chronic Hepatitis C, Co-infection, Induction dose, HIV, HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Study start
- Oct 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 26 Jul 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.
The purpose of this study is to compare the early virological response (EVR = undetectable [ribonucleic acid-hepatitis C virus] RNA-HCV or a reduction of > 2 log10) of patients with chronic hepatitis C coinfected with HIV treated with induction doses of peginterferon alpha-2a (40 KD) 270 µg/week and ribavirin 1600 mg/day for 4 weeks, followed by 8 weeks of treatment with peginterferon alpha-2a (40 KD) 180 µg/week and ribavirin 1000-1200 mg/day versus treatment with peginterferon alpha-2a (40 KD) 180 µg/week and ribavirin 1000-1200 mg/day for 12 weeks.
Detailed description
This study seeks to ascertain whether treatment with higher doses of PEGASYS (270 µg/week) and ribavirin (1600 mg/day) for the first four weeks achieves the plasma concentrations of the product in the blood needed to reduce the half-life of the virions and accelerate the elimination thereof. This would bring the viral kinetic curves in coinfected patients closer to the model described for mono-infected HCV patients, probably achieving improved rates of response in week 12 (early virological response) and posterior in week 72 (sustained virological response).
Therefore, the patients were randomised to treatment with two different doses, 270 µg and 180 µg of PEGASYS, and 1600 mg and 1000-1200 mg of ribavirin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Peginterferon alfa-2a, Ribavirin, epoetin-βPeginterferon alfa-2a (40 KD) (270 µg/week) + Ribavirin (1600 mg/day) + epoetin-β (450 UI/kg/week) for 4 weeks. Peginterferon alfa-2a (40 KD) (180 µg/week) + Ribavirin (1000-1200 mg/day) for 8 weeks |
| B | Experimental | Drug: Peginterferon alfa-2a + Ribavirin for 12 weeksPeginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Serological evidence of chronic hepatitis C infection in an anti-HCV antibody test
- Detectable RNA-HCV plasma level genotype 1 and 4
- ALT serum activity above the upper limit of normality
- Chronic liver disease consistent with chronic hepatitis C infection in a biopsy obtained during the two years prior to inclusion in the study
- Serological evidence of HIV-1 infection, diagnosed by Enzyme-Linked Immunosorbent Assay (ELISA) and confirmed by Western-blot.
Key exclusion criteria (5 listed)
- Women currently pregnant or in the lactation period.
- Patients whose companion is pregnant.
- Therapy with interferon (IFN) or ribavirin at any previous time.
- Patients with cirrhosis in the hepatic biopsy.
- Documented suspicion by ultrasound of hepatocarcinoma.
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 |
|---|---|---|
| Peginterferon alfa-2a, Ribavirin, epoetin-βPeginterferon alfa-2a(270 µg/week) + Ribavirin (1600 mg/day) + epoetin-β (450 UI/kg/week) for 4 weeks. Peginterferon alfa-2a (180 µg/week) + Ribavirin(1000-1200 mg/day) for 8 weeks | Drug | A |
| Peginterferon alfa-2a + Ribavirin for 12 weeksPeginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks | Drug | B |
Primary outcome
Percentage of patients with undetectable RNA-HCV
Time frame: at week 12 after starting treatment
8 secondary outcomes
Variations of the levels of RNA-HCV
Time frame: from baseline until weeks 4, 8, and 12 of the study
Percentage of patients with undetectable HCV RNA
Time frame: in weeks 4 and 8 of the study
Levels of ALT
Time frame: At weeks 4, 8, and 12
Percentage of patients that must reduce the dose of peginterferon alpha-2a (40 KD) and ribavirin.
Time frame: During the 12 weeks of follow-up
Percentage of patients that drop out of the study for adverse effects or intolerance
Time frame: During the 12 weeks of follow-up
Variations in levels of haemoglobin, neutrophil, and platelet count
Time frame: at 4, 8, and 12 weeks with regard to baseline
AIDS-defining events or death
Time frame: During the 12 weeks of follow-up
Changes in the CD4/CD8 cell count
Time frame: At 4, 8, and 12 weeks of follow-up
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 4 Dec 2019.
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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.
Bonaventura Clotet, MD, PhD principal investigator
LLuita contra la Sida Foundation-HIV Unit
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Peginterferon alfa-2a, Ribavirin, epoetin-β and Peginterferon alfa-2a + Ribavirin for 12 weeks in people with HIV Infections, run by Germans Trias i Pujol Hospital at 12 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 10 inclusion and 5 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 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 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?
Percentage of patients with undetectable RNA-HCV (time frame: at week 12 after starting treatment). 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 4 Dec 2019.