Hepatitis C, ChronicPhase 4HIVCOBOC-RGTNCT01925183
Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C
A Phase 4 study testing Pegylated interferon alpha-2a, Ribavirin and Boceprevir in people with Hepatitis C, Chronic and HIV, run by Markus Peck-Radosavljevic at 1 site in Austria.
Trial summary
Response-guided triple-therapy with boceprevir (BOC) in combination with pegylated interferon (PEGIFN) and ribavirin (RBV) is the current standard of care for HIV-negative patients infected with hepatitis C genotype (HCV-GT) 1. In contrast, in HIV-positive patients, a fixed treatment duration of 48 weeks is used. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Hepatitis C, Chronic, HIV
- What is being tested?
- Pegylated interferon alpha-2a, Ribavirin and Boceprevir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2013to Jun 2015
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed HIV infection (anti-HIV1/2 antibody positive).
- Chronic HCV infection (anti-HCV positive, HCV-RNA detectable for >6 months).
- HCV-GT 1 infection.
- Age ≥18 years and ≤65 years.
- No prior treatment with BOC/PEGIFN/RBV.
- CD4+ cell count >200 cells/µL.
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- Stable antiretroviral therapy (ART) including tenofovir/emtricitabine (Truvada®, Gilead) and raltegravir (Isentress®, MSD) with HIV-RNA <50 copies/mL.
- Valid result on transient elastography or liver biopsy within 6 months prior to enrollment.
- Female patients of childbearing potential must agree to use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
- Male patients or their female partners must agree to use an effective contraceptive during treatment and for 7 months after treatment has been concluded.
Who cannot join
- HCV-GT other than HCV-GT 1.
- Cirrhotic patients (as defined by METAVIR F4 in liver biopsy or liver stiffness >12.3 kPa) with decompensated liver disease (Child-Pugh stage B/C).
- Chronic liver diseases other than hepatitis C virus infection (hepatitis B virus infection: HBsAg positivity, nonalcoholic steatohepatitis, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, cystic fibrosis).
- Significant cardiac disease (ejection fraction <40% at echocardiography).
- Significant pulmonary disease (COPD stage GOLD III/IV).
- Significant renal disease (serum creatinine >1.5 mg/dL).
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- Subjects taking medication(s) that is/are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events such as but not limited to, orally administered midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, and ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine).
- Contraindications for boceprevir (Victrelis®, MSD), pegylated interferon alpha-2a (Pegasys®, Roche) or ribavirin (Copegus®, Roche), as listed in section 4.3 of the respective summary of product characteristics (SmPCs).
- Ongoing alcohol abuse (average daily alcohol consumption >50g).
- Ongoing illicit drug abuse.
- Unwillingness to give written informed consent.
- Pregnancy and breastfeeding.
- Women wishing to become pregnant.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna
Vienna, State of Vienna, 1090
About this study
Official title: Response-guided Triple-therapy Using Boceprevir in Combination With PEGIFN/RBV in HIV/HCV-coinfected Patients
Response-guided triple-therapy with boceprevir (BOC) in combination with pegylated interferon (PEGIFN) and ribavirin (RBV) is the current standard of care for HIV-negative patients infected with hepatitis C genotype (HCV-GT) 1. In contrast, in HIV-positive patients, a fixed treatment duration of 48 weeks is used.
The aim of this study is to assess efficacy and safety of response-guided triple-therapy with BOC in combination with PEGIFN and RBV in HIV-positive patients. Thus, treatment duration will be individualized based on HCV-RNA negativity at treatment week 8 (W8). All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at W8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks, while patients with detectable HCV-RNA at W8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks.
- Conditions
- Hepatitis C, Chronic, HIV
- Being tested
- Pegylated interferon alpha-2a, Ribavirin, Boceprevir
- Keywords
- Boceprevir, HIV/HCV-coinfection, HIV/HCV coinfection, HIV/HCV, Response-guided therapy
- 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.
Pegylated interferon alpha-2aDrug
Also called Pegasys®, Roche
180mcg once weekly; subcutaneous injection
RibavirinDrug
Also called Copegus®, Roche
600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally
BoceprevirDrug
Also called Victrelis®, MSD
800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
| Study group | Role | What they receive |
|---|---|---|
| 28 weeks of treatment duration | Experimental | All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks. Receives: Drug: Pegylated interferon alpha-2a; Drug: Ribavirin; Drug: Boceprevir |
| 48 weeks of treatment duration | Experimental | All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks Receives: Drug: Pegylated interferon alpha-2a; Drug: Ribavirin; Drug: Boceprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With Sustained Virologic Response (SVR12)
Defined as HCV-RNA negativity by a sensitive assay
Measured: Follow-up week 12 (FU12)
Proportions of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Baseline (BL) to Follow-up week 12 (FU12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2015
- Study completionJun 2015
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.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Markus Peck-Radosavljevic
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna
- Responsible party
- Sponsor-investigator, Markus Peck-Radosavljevic, Medical University of Vienna
- Investigators
- Markus Peck-Radosavljevic, MD, Principal investigator, Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925183
- Sponsor's protocol ID
- HIVCOBOC-RGT
- Other IDs
- 2012-005591-33
- Acronym
- HIVCOBOC-RGT
- Status last verified
- Feb 2017
- First submitted
- 15 Aug 2013
- Last updated
- 16 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response-guided Triple-therapy Using Boceprevir in Combination With PEGIFN/RBV in HIV/HCV-coinfected Patients
- ClinicalTrials.gov ID
- NCT01925183
- Acronym / sponsor ID
- HIVCOBOC-RGT / HIVCOBOC-RGT
- Conditions
- Hepatitis C, Chronic, HIV
- Keywords
- Boceprevir, HIV/HCV-coinfection, HIV/HCV coinfection, HIV/HCV, Response-guided therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Markus Peck-RadosavljevicUniversity, hospital or other
- Collaborators
- Medical University of Vienna
- Study start
- Aug 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Aug 2013 (estimated)
- Results
- Posted 9 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Response-guided triple-therapy with boceprevir (BOC) in combination with pegylated interferon (PEGIFN) and ribavirin (RBV) is the current standard of care for HIV-negative patients infected with hepatitis C genotype (HCV-GT) 1. In contrast, in HIV-positive patients, a fixed treatment duration of 48 weeks is used.
The aim of this study is to assess efficacy and safety of response-guided triple-therapy with BOC in combination with PEGIFN and RBV in HIV-positive patients. Thus, treatment duration will be individualized based on HCV-RNA negativity at treatment week 8 (W8). All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at W8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks, while patients with detectable HCV-RNA at W8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 28 weeks of treatment duration | Experimental | Drug: Pegylated interferon alpha-2a, Drug: Ribavirin, Drug: BoceprevirAll patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks. |
| 48 weeks of treatment duration | Experimental | Drug: Pegylated interferon alpha-2a, Drug: Ribavirin, Drug: BoceprevirAll patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Confirmed HIV infection (anti-HIV1/2 antibody positive).
- Chronic HCV infection (anti-HCV positive, HCV-RNA detectable for >6 months).
- HCV-GT 1 infection.
- Age ≥18 years and ≤65 years.
- No prior treatment with BOC/PEGIFN/RBV.
Key exclusion criteria (13 listed)
- HCV-GT other than HCV-GT 1.
- Cirrhotic patients (as defined by METAVIR F4 in liver biopsy or liver stiffness >12.3 kPa) with decompensated liver disease (Child-Pugh stage B/C).
- Chronic liver diseases other than hepatitis C virus infection (hepatitis B virus infection: HBsAg positivity, nonalcoholic steatohepatitis, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, cystic fibrosis).
- Significant cardiac disease (ejection fraction <40% at echocardiography).
- Significant pulmonary disease (COPD stage GOLD III/IV).
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 alpha-2aAlso: Pegasys®, Roche180mcg once weekly; subcutaneous injection | Drug | 28 weeks of treatment duration, 48 weeks of treatment duration |
| RibavirinAlso: Copegus®, Roche600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally | Drug | 28 weeks of treatment duration, 48 weeks of treatment duration |
| BoceprevirAlso: Victrelis®, MSD800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally | Drug | 28 weeks of treatment duration, 48 weeks of treatment duration |
Primary outcome
Proportion of Subjects With Sustained Virologic Response (SVR12)
Time frame: Follow-up week 12 (FU12)
Defined as HCV-RNA negativity by a sensitive assay
Proportions of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline (BL) to Follow-up week 12 (FU12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Markus Peck-Radosavljevic, MD principal investigator
Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna
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 alpha-2a, Ribavirin and Boceprevir in people with Hepatitis C, Chronic and HIV, run by Markus Peck-Radosavljevic at 1 site in Austria.
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 13 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 16 Mar 2017. 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 Austria. 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?
Yes. Results are posted in the registry (first posted 9 Feb 2017). 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?
Proportion of Subjects With Sustained Virologic Response (SVR12) (time frame: Follow-up week 12 (FU12)). 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?
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 16 Mar 2017.