Hepatitis C, ChronicPhase 4NCT00353418
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Genotype 1 and Human Immunodeficiency Virus-1 (HIV-1) Co-infection
A Phase 4 study testing Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche.
Trial summary
This 2-arm study will compare the efficacy and safety of treatment with Pegasys (180 µg weekly) plus Copegus (800 mg daily) and Pegasys (180 µg weekly) plus Copegus (1000-1200 mg daily) in interferon-naive patients with CHC genotype 1 co-infected with HIV-1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Peginterferon alfa-2a and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Apr 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult patients, ≥18 years of age
- CHC genotype 1
- Stable HIV-1 infection
Who cannot join
- Previous treatment with an alpha interferon, ribavirin, viramidine, levovirin, amantadine or investigational HCV protease or polymerase inhibitors
- Medical condition associated with liver disease other than CHC infection
About this study
Official title: A Randomized, Multicenter, Double Blinded Study Comparing the Safety and Efficacy of Pegasys® 180 ug Plus Copegus® 1000 or 1200 mg to the Currently Approved Combination of Pegasys® 180 ug Plus Copegus® 800 mg in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection and HIV-1
This 2-arm study will compare the efficacy and safety of treatment with Pegasys (180 µg weekly) plus Copegus (800 mg daily) and Pegasys (180 µg weekly) plus Copegus (1000-1200 mg daily) in interferon-naive patients with CHC genotype 1 co-infected with HIV-1. Treatment will be administered for 48 weeks, and this will be followed by 24 treatment-free weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Peginterferon alfa-2a, Ribavirin
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2aDrug
Also called Pegasys
180 µg subcutaneously weekly for 48 weeks
RibavirinDrug
Also called Copegus
800 mg orally daily for 48 weeks
RibavirinDrug
Also called Copegus
1000 mg or 1200 mg (based on patient weight of < 75 kg or ≥ 75 kg, respectively) orally daily for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg | Experimental | Not described Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin |
| PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg | Active comparator | Not described Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virological Response (SVR)
SVR was defined by the percentage of patients with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of the 48-week treatment period (i.e., a single last HCV RNA < 20 IU/mL measured ≥ Day 477 [≥ Week 68]). Patients without an HCV measurement at the end of the 24-week untreated follow-up period were considered nonresponders.
Measured: Week 72
Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia
Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia.
Measured: Up to Week 72
Secondary outcomes (5)
Virological Response at End of Treatment Period
Virological response at the end of the treatment period was defined as a single last HCV RNA measurement <20 IU/mL at the completion of the treatment period (Days 324 to 351). Patients without an HCV measurement at Week 48 were considered nonresponders.
Measured: Week 48
Virological Response at Weeks 4, 12 and 24
Virological response at Weeks 4, 12 and 24 was also defined as a single last undetectable HCV RNA (< 20 IU/mL) falling within the visit windows of Days 16 to 43, 72 to 99, and 156 to 183, respectively. Patients without an HCV measurement at a study week were considered nonresponders at that study week.
Measured: Weeks 4, 12 and 24
Relapse of Virological Response
Relapse of virological response was calculated by dividing the number of patients who achieved a virological response at the end of treatment but had detectable HCV RNA at the last assessment posttreatment by the number of patients with a virological response at the end of treatment who had at least one HCV RNA assessment posttreatment.
Measured: Weeks 48 and 72
Rapid Virological Response (RVR) by Week 4
RVR was defined as an undetectable HCV RNA < 20 IU/mL (a single last HCV RNA < 20 IU/mL falling in the time window of Days 2 to 43). Patients without an HCV measurement by Week 4 were considered nonresponders.
Measured: Week 4
Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12
EVR: Undetectable HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level, by Week 12 (a single last HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level in the time window of Days 2 to 99). Partial EVR: Detectable HCV RNA but ≥2 log10 drop from pretreatment, by Week 12 (a single last HCV RNA detectable but ≥2 log10 drop from pretreatment in the time window of Days 2 to 99). Complete EVR: Undetectable HCV RNA <20 IU/mL, by Week 12 (a single last HCV RNA <20 IU/mL in the time window of Days 2 to 99). Patients without an HCV measurement by Week 12 were considered nonresponders.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353418
- Sponsor's protocol ID
- NV18209
- Status last verified
- Jul 2010
- First submitted
- 17 Jul 2006
- Last updated
- 3 Aug 2010
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Rodriguez-Torres M, Slim J, Bhatti L, Sterling R, Sulkowski M, Hassanein T, Serrao R, Sola R, Bertasso A, Passe And S, Stancic S. Peginterferon alfa-2a plus ribavirin for HIV-HCV genotype 1 coinfected patients: a randomized international trial. HIV Clin Trials. 2012 May-Jun;13(3):142-52. doi: 10.1310/hct1303-142.
PubMed 22592094
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double Blinded Study Comparing the Safety and Efficacy of Pegasys® 180 ug Plus Copegus® 1000 or 1200 mg to the Currently Approved Combination of Pegasys® 180 ug Plus Copegus® 800 mg in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection and HIV-1
- ClinicalTrials.gov ID
- NCT00353418
- Acronym / sponsor ID
- NV18209
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 18 Jul 2006 (estimated)
- Results
- Posted 15 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 2-arm study will compare the efficacy and safety of treatment with Pegasys (180 µg weekly) plus Copegus (800 mg daily) and Pegasys (180 µg weekly) plus Copegus (1000-1200 mg daily) in interferon-naive patients with CHC genotype 1 co-infected with HIV-1. Treatment will be administered for 48 weeks, and this will be followed by 24 treatment-free weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg | Experimental | Drug: Peginterferon alfa-2a, Drug: Ribavirin |
| PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg | Active comparator | Drug: Peginterferon alfa-2a, Drug: Ribavirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients, ≥18 years of age
- CHC genotype 1
- Stable HIV-1 infection
Key exclusion criteria (2 listed)
- Previous treatment with an alpha interferon, ribavirin, viramidine, levovirin, amantadine or investigational HCV protease or polymerase inhibitors
- Medical condition associated with liver disease other than CHC infection
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-2aAlso: Pegasys180 µg subcutaneously weekly for 48 weeks | Drug | PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg, PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg |
| RibavirinAlso: Copegus800 mg orally daily for 48 weeks | Drug | PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg |
| RibavirinAlso: Copegus1000 mg or 1200 mg (based on patient weight of < 75 kg or ≥ 75 kg, respectively) orally daily for 48 weeks | Drug | PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg |
Primary outcome
Sustained Virological Response (SVR)
Time frame: Week 72
SVR was defined by the percentage of patients with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of the 48-week treatment period (i.e., a single last HCV RNA < 20 IU/mL measured ≥ Day 477 [≥ Week 68]). Patients without an HCV measurement at the end of the 24-week untreated follow-up period were considered nonresponders.
Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia
Time frame: Up to Week 72
Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia.
5 secondary outcomes
Virological Response at End of Treatment Period
Time frame: Week 48
Virological Response at Weeks 4, 12 and 24
Time frame: Weeks 4, 12 and 24
Relapse of Virological Response
Time frame: Weeks 48 and 72
Rapid Virological Response (RVR) by Week 4
Time frame: Week 4
Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22592094Rodriguez-Torres M, Slim J, Bhatti L, Sterling R, Sulkowski M, Hassanein T, Serrao R, Sola R, Bertasso A, Passe And S, Stancic S. Peginterferon alfa-2a plus ribavirin for HIV-HCV genotype 1 coinfected patients: a randomized international trial. HIV Clin Trials. 2012 May-Jun;13(3):142-52. doi: 10.1310/hct1303-142.
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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.
Clinical Trials study director
Hoffmann-La Roche
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche.
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 3 inclusion and 2 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 3 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 15 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Virological Response (SVR) (time frame: Week 72). The study lists 2 primary outcomes in all. 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 NCT00353418, 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 3 Aug 2010.