Hepatitis CPhase 3BOC-HIVNCT01718301
HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin
A Phase 3 study testing boceprevir, Ribavirin and Peginterferon alfa-2a in people with Hepatitis C and HIV Infections, run by Anna Cruceta at 1 site in Spain.
Trial summary
The primary objective of this study is to evaluate the safety and efficacy of a Response Guided Therapy of boceprevir 800 mg dosed three times a day (TID) orally (PO) in combination with Peginterferon (either alpha 2b or alpha 2a) and Ribavirin in HIV/HCV genotype 1 infected patients that failed to previous HCV… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, HIV Infections, COINFECTION
- What is being tested?
- boceprevir, Ribavirin and Peginterferon alfa-2a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- 10 Mar 2013to 30 Jun 2015
- Phase
- Phase 3
- 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
- For inclusion in the study, subjects must have a qualifying regimen defined as peginterferon alfa-2a plus ribavirin or peginterferon alfa-2b plus ribavirin for a minimum of 12 weeks. If a subject has received more than one such regimen, the most recent regimen is considered the qualifying regimen.
- Subject must have previously documented chronic hepatitis C (CHC) genotype 1 infection. Subjects with other or mixed genotypes are not eligible. The HCV-RNA result at the screening visit must confirm genotype 1 infection and be ≥10,000 IU/mL.
- Subject must have a liver biopsy with histology consistent with CHC and no other etiology and/or Fibroscan assessment. In case of:
- No cirrhosis. Biopsies and/or Fibroscan must be within 18 months of screening visit.
- Cirrhosis. No specific length of time would be requested.
- All patients with cirrhosis must have an ultrasound 6 month within of screening visit.
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- Patients must be on stable antiretroviral therapy including a CD4 cell count of more than 100 per mm3 and a HIV plasmatic viral load undetectable (it is < 50 copies/mL) for more than 6 months. Antiretroviral therapy must be Raltegravir-based (al least during the last 3 months).
- Subject must be ≥18 years of age.
- HIV treatment should not contain efavirenz (EFV), nevirapine (NVP), etravirine (ETV), didanosine (ddI), stavudine (d4T), zidovudine (AZT), or HIV protease inhibitors.
- Subject must weight between 40 kg and 125 kg.
- Subject and subject's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug.
- Subjects must be willing to give written informed consent and by investigator opinion be able to follow the protocol visit design.
Who cannot join
- Subjects known to be coinfected with hepatitis B virus (HBsAg positive).
- Patients chronically infected with HCV genotype other than 1
- CD4 cell count < 100 cel/mm3.
- Plasma HIV RNA more than 50 copies/mL
- Platelet count less than 80.000 /mm3
- Subjects who required discontinuation of previous interferon or ribavirin regimen for a severe adverse event considered by the investigator to be possibly or probably related to ribavirin and/or interferon.
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- Treatment with ribavirin within 90 days and any interferon-alpha within 1 month of Screening.
- Treatment for hepatitis C with any investigational medication. Prior treatments with herbal remedies with known hepatotoxicity are exclusionary.
- Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study.
- History of hemoglobinopathy (e.g., thalassemia) or any other cause of or tendency to hemolysis.
- Evidence of decompensate liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
- Diabetic and/or hypertensive subjects with clinically significant ocular examination findings.
- Unstable or untreated pre-existing psychiatric condition.
- Any known pre-existing medical condition that could interfere with the subject's participation in and completion of the study.
- Any current evidence of substance abuse of alcohol or other drugs.
- Subjects receiving opioid agonist substitution therapy but not enrolled in an opiate substitution maintenance program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate Safety and Efficacy of Boceprevir-response Guided Therapy in Controlled HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin Eudra CT2012-003984-23
The primary objective of this study is to evaluate the safety and efficacy of a Response Guided Therapy of boceprevir 800 mg dosed three times a day (TID) orally (PO) in combination with Peginterferon (either alpha 2b or alpha 2a) and Ribavirin in HIV/HCV genotype 1 infected patients that failed to previous HCV therapy.
Read the detailed description
In a total number of 108 patients the protocol was evaluated but only in 102 the protocol efectively was presented. In the remaining 6 patients we don't believe the trial could be performed.
- Conditions
- Hepatitis C, HIV Infections, COINFECTION
- Being tested
- boceprevir, Ribavirin, Peginterferon alfa-2a, Peginterferon alfa-2b
- Keywords
- HCV, HIV, Coinfection
- Medical subject headings
- Hepatitis C, HIV Infections, Coinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
boceprevirDrug
RibavirinDrug
Peginterferon alfa-2aDrug
Peginterferon alfa-2bDrug
| Study group | Role | What they receive |
|---|---|---|
| boceprevir + ribavirin + peginterferon | Experimental | boceprevir 800 mg three times a day (v.o.) in combination with peginterferon (alfa-2b or alfa-2a) and ribavirin Receives: Drug: boceprevir; Drug: Ribavirin; Drug: Peginterferon alfa-2a; Drug: Peginterferon alfa-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of Sustained Virological Response (SVR) at 24 Weeks Post-Treatment
Achievement of SVR, defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24.
If a subject is missing FW 24 data and has undetectable HCV-RNA level at FW 12, the subject would be considered an SVR.
Measured: Week 24
Secondary outcomes (5)
Achievement of Sustained Virological Response at Weeks 2,4,8,12.
Proportion of participants with undetectable HCV RNA (<15 IU/mL) at weeks 2, 4, 8, and 12 during treatment.
Measured: Weeks 2, 4, 8, 12
The Proportion of Subjects With Undetectable HCV-RNA at FW 12.
The proportion of subjects with undetectable HCV-RNA at follow-up week 12.
Measured: Week 12
The Proportion of Subjects With Undetectable HCV-RNA at 72 Weeks After Randomization.
The proportion of randomized subjects with undetectable HCV-RNA at 72 weeks after randomization.
Measured: Week 72
Number of Adverse Events
Safety: number of adverse events
Measured: From baseline to study completion (up to 72 weeks)
Resistance of HCV After Boceprevir (BOC) Containing Regimen
Resistance of HCV after boceprevir containing regimen. Blood samples will be collected at baseline and after HCV virological failure and resistance analysis will be done at the end of the study in a single Center (Hospital Clínic-Barcelona).
Measured: whenever resistance occurs during the study (from week 12 until the date the resistance occurs, assessed up to 72 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study start10 Mar 2013
- Primary completion20 Mar 2015
- Study completion30 Jun 2015
Why it stopped: Difficulty in patient recruitment
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 CStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Cruceta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Josep Mallolas, MD, Principal investigator, Hospital Clínic i Provincial de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718301
- Sponsor's protocol ID
- BOC-HIV
- Other IDs
- 2012-003984-23
- Acronym
- BOC-HIV
- Status last verified
- Aug 2025
- First submitted
- 25 Oct 2012
- Last updated
- 24 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Safety and Efficacy of Boceprevir-response Guided Therapy in Controlled HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin Eudra CT2012-003984-23
- ClinicalTrials.gov ID
- NCT01718301
- Acronym / sponsor ID
- BOC-HIV / BOC-HIV
- Conditions
- Hepatitis C, HIV Infections, COINFECTION
- Keywords
- HCV, HIV, Coinfection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in patient recruitment
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Anna CrucetaUniversity, hospital or other
- Study start
- 10 Mar 2013 (actual)
- Primary completion
- 20 Mar 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Posted 24 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and efficacy of a Response Guided Therapy of boceprevir 800 mg dosed three times a day (TID) orally (PO) in combination with Peginterferon (either alpha 2b or alpha 2a) and Ribavirin in HIV/HCV genotype 1 infected patients that failed to previous HCV therapy.
Detailed description
In a total number of 108 patients the protocol was evaluated but only in 102 the protocol efectively was presented. In the remaining 6 patients we don't believe the trial could be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| boceprevir + ribavirin + peginterferon | Experimental | Drug: boceprevir, Drug: Ribavirin, Drug: Peginterferon alfa-2a, Drug: Peginterferon alfa-2bboceprevir 800 mg three times a day (v.o.) in combination with peginterferon (alfa-2b or alfa-2a) and ribavirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- For inclusion in the study, subjects must have a qualifying regimen defined as peginterferon alfa-2a plus ribavirin or peginterferon alfa-2b plus ribavirin for a minimum of 12 weeks. If a subject has received more than one such regimen, the most recent regimen is considered the qualifying regimen.
- Subject must have previously documented chronic hepatitis C (CHC) genotype 1 infection. Subjects with other or mixed genotypes are not eligible. The HCV-RNA result at the screening visit must confirm genotype 1 infection and be ≥10,000 IU/mL.
- Subject must have a liver biopsy with histology consistent with CHC and no other etiology and/or Fibroscan assessment. In case of:
- All patients with cirrhosis must have an ultrasound 6 month within of screening visit.
- Patients must be on stable antiretroviral therapy including a CD4 cell count of more than 100 per mm3 and a HIV plasmatic viral load undetectable (it is < 50 copies/mL) for more than 6 months. Antiretroviral therapy must be Raltegravir-based (al least during the last 3 months).
Key exclusion criteria (16 listed)
- Subjects known to be coinfected with hepatitis B virus (HBsAg positive).
- Patients chronically infected with HCV genotype other than 1
- CD4 cell count < 100 cel/mm3.
- Plasma HIV RNA more than 50 copies/mL
- Platelet count less than 80.000 /mm3
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 |
|---|---|---|
| boceprevir | Drug | boceprevir + ribavirin + peginterferon |
| Ribavirin | Drug | boceprevir + ribavirin + peginterferon |
| Peginterferon alfa-2a | Drug | boceprevir + ribavirin + peginterferon |
| Peginterferon alfa-2b | Drug | boceprevir + ribavirin + peginterferon |
Primary outcome
Achievement of Sustained Virological Response (SVR) at 24 Weeks Post-Treatment
Time frame: Week 24
Achievement of SVR, defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If a subject is missing FW 24 data and has undetectable HCV-RNA level at FW 12, the subject would be considered an SVR.
5 secondary outcomes
Achievement of Sustained Virological Response at Weeks 2,4,8,12.
Time frame: Weeks 2, 4, 8, 12
The Proportion of Subjects With Undetectable HCV-RNA at FW 12.
Time frame: Week 12
The Proportion of Subjects With Undetectable HCV-RNA at 72 Weeks After Randomization.
Time frame: Week 72
Number of Adverse Events
Time frame: From baseline to study completion (up to 72 weeks)
Resistance of HCV After Boceprevir (BOC) Containing Regimen
Time frame: whenever resistance occurs during the study (from week 12 until the date the resistance occurs, assessed up to 72 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- 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.
Josep Mallolas, MD principal investigator
Hospital Clínic i Provincial de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing boceprevir, Ribavirin and Peginterferon alfa-2a in people with Hepatitis C and HIV Infections, run by Anna Cruceta 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 12 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: stopped early, as of the sponsor's last update on 24 Aug 2025. 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 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?
Yes. Results are posted in the registry (first posted 24 Aug 2025). 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?
Achievement of Sustained Virological Response (SVR) at 24 Weeks Post-Treatment (time frame: Week 24). 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 24 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.