HCV CoinfectionPhase 2BocepreVIHNCT01335529
Boceprevir in HIV-HCV Coinfected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin
A Phase 2 study testing Boceprevir, Peg-interferon alfa 2b and Ribavirin in people with HCV Coinfection and HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial summary
The majority of Human immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) co-infected patients are non responders after 48 weeks of the current standard-of-care with Peg-Interferon/Ribavirin. The results of re-treatment are disappointing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCV Coinfection, HIV-1 Infection
- What is being tested?
- Boceprevir, Peg-interferon alfa 2b 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
- 69 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to May 2014
- Phase
- Phase 2
- 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
- Adult ≥18 years
- HIV-1 infection
- Infection to genotype 1 HCV only
- Patients must have received at least 12 weeks of treatment with Peg-Interferon alfa 2a ≥ 135 µg / once weekly or Peg-Interferon alfa 2b ≥ 1,0 µg/kg/ once weekly + Ribavirin ≥ 600 mg daily and must have failed to treatment.
- Anti-HCV treatment stopped for at least 6 months
- Patients must be already treated at screen since at least 3 months with a stable combination of antiretroviral treatment as following:
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- Either tenofovir - emtricitabine, and atazanavir in combination with ritonavir
- Or tenofovir - emtricitabine, and raltegravir
- If patients cannot receive neither of the two antiretroviral regimens proposed, for virologic, safety or toxicity reasons, patients could receive any effective antiretroviral therapy including : tenofovir, emtricitabine, lamivudine, atazanavir alone or in combination with ritonavir, raltegravir, abacavir. These patients are not allowed to take part in the pharmacokinetic sub-study.
- CD4 > 200/mm3 et >15%, at screen
- HIV-RNA < 50 copies/ml since at least 6 months at screen
- ≥ 40 Kg and ≤ 125 Kg
- Patients with any fibrosis grade. Proportion of F4 subjects should not excess 50% of the overall subjects.
- Male and female subjects must agree to use acceptable methods of contraception 1 month prior to starting the study treatment and to continue until 7 months after the last doses of study drugs for male subjects and their partner(s), 4 months for female subjects.
- Subjects must be willing to give written informed consent for principal study (signed at least at screen visit and prior to any study investigation)and + for the pharmacokinetic sub-study (for the concerned centers).
- Subjects must be willing to give written informed consent for biological collection.
- Subjects must be willing to give written informed consent for treatment of genetics data.
- Subjects affiliated or beneficiary to a medical insurance.
Who cannot join
- History:
- Patients with cirrhosis (F4) and nul responders to prior treatment
- Cirrhosis classified Child-Pugh B or C or history of decompensated cirrhosis of the liver. If Child A classification, significant varicose veins (grade 2 or 3) observed with a fibroscopy realized for < 3 years.
- History of ocular neuritis, retinal disorders, transplant
- Opportunistic infections (classification C), active or occurred within the 6 months prior to baseline.
- History of neoplasia within the last 5 years, except cutaneous basocellular carcinoma, recovering Kaposi's sarcoma, in situ cervical or anal canal cancer.
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- Current condition:
- Co-infection with Hepatitis B virus
- Pregnancy and lactation
- Cardiac or severe pulmonary disease
- Untreated dysthyroidism
- Autoimmune disease contraindicating to an interferon treatment
- Severe haemoglobinopathies
- Any condition needing a systemic corticotherapy or an immunosuppressive treatment
- Evolutive current malignancy, including hepatocarcinoma which should be specifically controlled prior to baseline.
- Alcohol consumption which may disturb the study participation according to the investigator
- Drug addiction which may disturb the study participation according to the investigator. Patients taking part to a substitution program with methadone or buprenorphine are allowed to be enrolled in the study.
- Biological criteria:
- Haemoglobin < 12 g/dL (female) or < 13g/dL (male), Platelets < 90 000/mm3, Neutrophil count < 1500/mm3, Renal failure defined as creatinine clearance < 50ml/min, Uncontrolled thyroid function, HbA1c ≥ 7% in case of diabetes
- Criteria related to study drugs
- Contra-indication to Ribavirin, interferon treatment including psychiatric contra-indications.
- History of discontinuation for intolerance to anti-HCV treatment.Patients with a history of discontinuation for intolerance, especially anaemia or leuconeutropenia, and who were not treated with hematopoietic growth factor, are eligible
- Concomitant medication which may interfere with Boceprevir, atazanavir, ritonavir and raltegravir pharmacokinetic
- St.John's-wort consumption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Assess the Efficacy and Safety of Boceprevir, in Combination With Peg-Interferon Alfa and Ribavirin, in Patients With HCV/HIV Co-infection Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin
The majority of Human immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) co-infected patients are non responders after 48 weeks of the current standard-of-care with Peg-Interferon/Ribavirin. The results of re-treatment are disappointing. The addition of Boceprevir to the current standard-of-care has been shown to increase the efficacy of therapy in HCV mono-infected patients previously treated with a bi-therapy. Knowing that HIV/HCV co-infected patients are subject to more rapid hepatic fibrosis as well as to increased risks of cirrhosis, end-stage liver disease and hepatocellular carcinoma, it is important to improve the response rate of the re-treatment of hepatitis C in these patients.
The aim of this pilot study is to evaluate the efficacy and safety of Boceprevir in combination with Peg-Interferon alfa 2b plus ribavirin, in patients co-infected with HIV and chronic genotype 1 HCV, and previously treated with Peg-Interferon/Ribavirin. 80 subjects will be enrolled. The primary endpoint will be the Sustained Virologic Response (SVR) defined as undetectable HCV-RNA at Week 24 after the end of therapy.
Read the detailed description
The majority of HIV/HCV co-infected patients are non responders after 48 weeks of the current standard-of-care with Peg-Interferon/Ribavirin. The results of re-treatment are disappointing. The addition of Boceprevir to the current standard-of-care has been shown to increase the efficacy of therapy in HCV mono-infected patients previously treated with a bi-therapy. Knowing that HIV/HCV co-infected patients are subject to more rapid hepatic fibrosis as well as to increased risks of cirrhosis, end-stage liver disease and hepatocellular carcinoma, it is important to improve the response rate of the re-treatment of hepatitis C in these patients.
Subjects enrolled in this trial will have many predictive factors of failure: HIV co-infection, previous failure to Peg-Interferon/Ribavirin, HCV genotype 1 infection. One study reported a SVR rate of 9% after re-treatment with Peg-Interferon/Ribavirin in such patients. Another trial has shown a substantial increase of the response rate with a tri-therapy in HCV mono-infected patients.
The investigators propose to carry out a multicentric, national, non-randomized phase II trial in 80 patients.
The proportion of patients with F4 cirrhosis will have to be inferior to 50% of enrolled subjects.
The number of null responders to a previous treatment (HCV RNA drop < 2 log10 at W12) and without F4 cirrhosis will have to be lower or equal to 20.
The primary objective of the study is to estimate, in Genotype 1 - HCV/HIV co-infected patients, non responders to a previous therapy with Peg-Interferon/Ribavirin, the rate of SVR after 48 or 72 weeks of a three-drug regimen containing Peg-Interferon, Ribavirin and Boceprevir according to the Virologic Response and to compare the SVR rate to a threshold rate 20%, lowest rate to consider a therapeutic benefit in this population.
A pharmacokinetic sub-study including 30 patients will be performed to estimate pharmacokinetic parameters of antiretroviral treatment (Atazanavir combined with Ritonavir, Raltegravir, Tenofovir) in combination with anti HCV treatment at baseline and W8 and pharmacokinetic parameters of Boceprevir at W8.
- Conditions
- HCV Coinfection, HIV-1 Infection
- Being tested
- Boceprevir, Peg-interferon alfa 2b and Ribavirin
- Keywords
- HCV infection, HIV-1 infection
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boceprevir, Peg-interferon alfa 2b and RibavirinDrug
Also called ViraferonPeg, Rebetol
- Screen period from Week-8
- Standard treatment from day 0 to week 4 (W4)
- Three-drug-regimen (Boceprevir introduction) from W4 to W8
- HCV RNA determination at W8 determines treatment group and participation duration:
- If undetectable HCV RNA at W8, it is a complete virological response: 3 drug-regimen is continued until W48, then there is a follow-up period up to W72 and SVR analysis,
- If HCV RNA ≤ 1000IU/mL at W8, it is an incomplete virological response. The 3-drug-regimen is continued until W72, when another analysis is done.
| Study group | Role | What they receive |
|---|---|---|
| Boceprevir, PegIFN alfa 2b, Ribavirin | Experimental | Standard Treatment :
* Peg-Interferon (PegIFN) alfa 2b by subcutaneous injection 1,5 µg/kg/week
* Ribavirin capsules 200mg: dosage delivered in weight categories (< 65 kg: 800 mg ; 65-80 kg: 1000 mg; 81-105 kg: 1200mg; > 105 kg: 1400mg)
Three-drug-regimen:
* Peg-Interferon alfa 2b by subcutaneous injection 1,5 µg/kg/week
* Ribavirin capsules 200mg: dosage delivered in weight categories like in standard treatment
* Boceprevir tablets 200mg: 800 mg 3 times a day (2400 mg/j) with food Receives: Drug: Boceprevir, Peg-interferon alfa 2b and Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virologic Response
HCV-RNA measured 24 weeks after the end of the HCV treatment (W72 or W96)
Measured: Week 72 or Week 96 (W72 or W96)
Secondary outcomes (23)
HCV viral load
HCV-RNA
Measured: W4, W8, W12, W16, W28, W36 and at treatment completion at W48/72
Predictive factors of Sustained virologic Response (SVR)
- Sex
- Age (< vs ≥ 40 years)
- Risk factor of HIV infection (drug consumer versus other risk factors)
- Risk factor of HCV infection (drug consumer versus other risk factors)
- Ethnic origin (Africano-American or Subsaharian-African or West Indies versus others)
- CDC stade (C vs. A-B)
- CD4 number (< vs. ≥ 350/mm3)
- HCV viral load (< versus ≥ 800 000 UI/ml)
- HCV genotype (1a versus 1b)
- Cirrhosis (F4 versus no cirrhosis)
- Alcohol, tobacco, cannabis, intravenous/nasal drugs consumption
- IL28 gene polymorphism
Measured: Baseline
HIV virologic endpoints
- HIV-RNA
- CD4 and CD8 count
Measured: W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48, W60, W72 and W84, W96 if treatment duration is 72 weeks
Residual plasmatic concentration (Cres) of Ribavirin
Measured: W4 and W8
Hepatic factors: liver fibrosis score
Evolution of liver fibrosis between baseline and 24 weeks post-treatment, according to baseline value and Sustained Virologic Response (at W4, W8, W16, W28, W48/72 and 24 weeks post-treatment).
Measured: Screen, W4, W8, W16, W28, W48, W72, W96.
Alcohol consumption
Measured: W4, W8, W16, W28, W48, W72, W96
Evaluation of Pharmacokinetic parameters of anti-retroviral treatments
Pharmacokinetic parameters (Cres, Cmax, AUC) of anti-retroviral treatments before (baseline) and after (W8) the starting of Boceprevir combination in a sub-group of subjects and according to UGTA1 polymorphism.
Measured: Day 0, W8
Clinical and biological adverse events
Measured: Up to 24 weeks after treatment completion (W72 or W96)
Number of participants classified by virologic failure type: non responder, relapser, null responder
- Relapse patients: undetectable HCV RNA at the end of therapy, becoming detectable after treatment cessation.
- Break-through patients: undetectable HCV-RNA at least once during treatment, becoming detectable before treatment cessation.
- Non-responder patients: detectable HCV-RNA at W24, never achieved undetectable and HCV RNA drop ≥ 2 log at W12.
- Null responder patients: HCV RNA drop < 2 log at W12
Measured: W8, W12, W16, W28, W48, W72, W96
ITPA gene polymorphism
The relation between ITPA gene polymorphism and onset of haemolytic anaemia will be analysed.
Measured: Day 0
CYP3A4 Polymorphism
Evaluation of Pharmacokinetic parameters (Cres, Cmax, AUC) of Boceprevir at W8 in a sub-group of subjects, according to antiretroviral treatment and CYP3A4 polymorphism.
Measured: W8
Maximal Concentration (Cmax) of antiretroviral treatments
Evaluation of Pharmacokinetic parameters (Cres, Cmax, AUC) of anti-retroviral treatments before (baseline) and after (W8) the starting of Boceprevir combination in a sub-group of subjects and according to UGTA1 polymorphism.
Measured: Day 0 and W8
Area Under the Curve (AUC) of antiretrovirals
Evaluation of pharmacokinetic parameters (Cres, Cmax, AUC) of anti-retroviral treatments before (baseline) and after (W8) the starting of Boceprevir combination in a sub-group of subjects and according to UGTA1 polymorphism.
Measured: Day 0 and W8
Insulin resistance
Evolution of insulin resistance between baseline and 24 weeks post-treatment according to baseline value and Sustained Virologic Response (at W4, W8, W16, W28, W48/72 and 24 weeks post-treatment).
Measured: at W4, W8, W16, W28, W48, W72, W96
Metabolic syndrome
Evaluation of metabolic syndroms parameters according to baseline value and Sustained Virologic Response (at W4, W8, W16, W28, W48/72 and 24 weeks post-treatment).
Measured: W4, W8, W16, W28, W48, W72, W96
Reasons and dates of treatment discontinuation
Measured: Up to W72
Perceived symptoms
Perceived symptoms will be assessed on "AC24 French AIDS scale"
Measured: Day 0, W28, W48, W72, W96
French AIDS questionnaire of compliance
Measured: W0, W28, W48, W72
Tobacco consumption
Measured: W4, W8, W16, W28, W48, W72, W96
Cannabis consumption
Measured: W4, W8, W16, W28, W48, W72, W96
Intravenous/nasal drugs consumption
Measured: W4, W8, W16, W28, W48, W72, W96
Residual Concentration (Cres) of atazanavir boosted or not by ritonavir
Measure of residual concentration of atazanavir for patients treated by atazanavir boosted or not by ritonavir at screening day, at W48 and in case of virological rebound (HIV and HCV).
Measured: At screening day, at W48 and in the case of virological rebound
Residual concentration (Cres) of ritonavir
Measure of residual concentration of ritonavir for patients treated by atazanavir boosted by ritonavir at screening day, at W48 and in case of virological rebound (HIV and HCV).
Measured: At screening day, at W48 and in the case of virological rebound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2014
- Study completionMay 2014
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 HCV CoinfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Rennes University Hospital, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Isabelle Poizot-Martin, MD, Principal investigator, University Hospital, MarseilleEric Bellissant, MD, PhD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335529
- Sponsor's protocol ID
- ANRS HC27 BOCEPREVIH
- Acronym
- BocepreVIH
- Status last verified
- Oct 2014
- First submitted
- 25 Mar 2011
- Last updated
- 13 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Poizot-Martin I, Bellissant E, Garraffo R, Colson P, Piroth L, Solas C, Renault A, Bourliere M, Halfon P, Ghosn J, Alric L, Naqvi A, Carrieri P, Molina JM; ANRS HC27 BOCEPREVIH Study Group. Addition of boceprevir to PEG-interferon/ribavirin in HIV-HCV-Genotype-1-coinfected, treatment-experienced patients: efficacy, safety, and pharmacokinetics data from the ANRS HC27 study. HIV Clin Trials. 2016 Mar;17(2):63-71. doi: 10.1080/15284336.2015.1135553. Epub 2016 Feb 11.
PubMed 27077673
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Efficacy and Safety of Boceprevir, in Combination With Peg-Interferon Alfa and Ribavirin, in Patients With HCV/HIV Co-infection Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin
- ClinicalTrials.gov ID
- NCT01335529
- Acronym / sponsor ID
- BocepreVIH / ANRS HC27 BOCEPREVIH
- Conditions
- HCV Coinfection, HIV-1 Infection
- Keywords
- HCV infection, HIV-1 infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Rennes University Hospital, Merck Sharp & Dohme LLC
- Study start
- May 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 14 Apr 2011 (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 majority of Human immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) co-infected patients are non responders after 48 weeks of the current standard-of-care with Peg-Interferon/Ribavirin. The results of re-treatment are disappointing. The addition of Boceprevir to the current standard-of-care has been shown to increase the efficacy of therapy in HCV mono-infected patients previously treated with a bi-therapy. Knowing that HIV/HCV co-infected patients are subject to more rapid hepatic fibrosis as well as to increased risks of cirrhosis, end-stage liver disease and hepatocellular carcinoma, it is important to improve the response rate of the re-treatment of hepatitis C in these patients.
The aim of this pilot study is to evaluate the efficacy and safety of Boceprevir in combination with Peg-Interferon alfa 2b plus ribavirin, in patients co-infected with HIV and chronic genotype 1 HCV, and previously treated with Peg-Interferon/Ribavirin. 80 subjects will be enrolled. The primary endpoint will be the Sustained Virologic Response (SVR) defined as undetectable HCV-RNA at Week 24 after the end of therapy.
Detailed description
The majority of HIV/HCV co-infected patients are non responders after 48 weeks of the current standard-of-care with Peg-Interferon/Ribavirin. The results of re-treatment are disappointing. The addition of Boceprevir to the current standard-of-care has been shown to increase the efficacy of therapy in HCV mono-infected patients previously treated with a bi-therapy. Knowing that HIV/HCV co-infected patients are subject to more rapid hepatic fibrosis as well as to increased risks of cirrhosis, end-stage liver disease and hepatocellular carcinoma, it is important to improve the response rate of the re-treatment of hepatitis C in these patients.
Subjects enrolled in this trial will have many predictive factors of failure: HIV co-infection, previous failure to Peg-Interferon/Ribavirin, HCV genotype 1 infection. One study reported a SVR rate of 9% after re-treatment with Peg-Interferon/Ribavirin in such patients. Another trial has shown a substantial increase of the response rate with a tri-therapy in HCV mono-infected patients.
The investigators propose to carry out a multicentric, national, non-randomized phase II trial in 80 patients.
The proportion of patients with F4 cirrhosis will have to be inferior to 50% of enrolled subjects.
The number of null responders to a previous treatment (HCV RNA drop < 2 log10 at W12) and without F4 cirrhosis will have to be lower or equal to 20.
The primary objective of the study is to estimate, in Genotype 1 - HCV/HIV co-infected patients, non responders to a previous therapy with Peg-Interferon/Ribavirin, the rate of SVR after 48 or 72 weeks of a three-drug regimen containing Peg-Interferon, Ribavirin and Boceprevir according to the Virologic Response and to compare the SVR rate to a threshold rate 20%, lowest rate to consider a therapeutic benefit in this population.
A pharmacokinetic sub-study including 30 patients will be performed to estimate pharmacokinetic parameters of antiretroviral treatment (Atazanavir combined with Ritonavir, Raltegravir, Tenofovir) in combination with anti HCV treatment at baseline and W8 and pharmacokinetic parameters of Boceprevir at W8.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Boceprevir, PegIFN alfa 2b, Ribavirin | Experimental | Drug: Boceprevir, Peg-interferon alfa 2b and RibavirinStandard Treatment : * Peg-Interferon (PegIFN) alfa 2b by subcutaneous injection 1,5 µg/kg/week * Ribavirin capsules 200mg: dosage delivered in weight categories (< 65 kg: 800 mg ; 65-80 kg: 1000 mg; 81-105 kg: 1200mg; > 105 kg: 1400mg) Three-drug-regimen: * Peg-Interferon alfa 2b by subcutaneous injection 1,5 µg/kg/week * Ribavirin capsules 200mg: dosage delivered in weight categories like in standard treatment * Boceprevir tablets 200mg: 800 mg 3 times a day (2400 mg/j) with food |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Adult ≥18 years
- HIV-1 infection
- Infection to genotype 1 HCV only
- Patients must have received at least 12 weeks of treatment with Peg-Interferon alfa 2a ≥ 135 µg / once weekly or Peg-Interferon alfa 2b ≥ 1,0 µg/kg/ once weekly + Ribavirin ≥ 600 mg daily and must have failed to treatment.
- Anti-HCV treatment stopped for at least 6 months
Key exclusion criteria (24 listed)
- Patients with cirrhosis (F4) and nul responders to prior treatment
- Cirrhosis classified Child-Pugh B or C or history of decompensated cirrhosis of the liver. If Child A classification, significant varicose veins (grade 2 or 3) observed with a fibroscopy realized for < 3 years.
- History of ocular neuritis, retinal disorders, transplant
- Opportunistic infections (classification C), active or occurred within the 6 months prior to baseline.
- History of neoplasia within the last 5 years, except cutaneous basocellular carcinoma, recovering Kaposi's sarcoma, in situ cervical or anal canal cancer.
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, Peg-interferon alfa 2b and RibavirinAlso: ViraferonPeg, Rebetol* Screen period from Week-8 * Standard treatment from day 0 to week 4 (W4) * Three-drug-regimen (Boceprevir introduction) from W4 to W8 * HCV RNA determination at W8 determines treatment group and participation duration: * If undetectable HCV RNA at W8, it is a complete virological response: 3 drug-regimen is continued until W48, then there is a follow-up period up to W72 and SVR analysis, * If HCV RNA ≤ 1000IU/mL at W8, it is an incomplete virological response. The 3-drug-regimen is continued until W72, when another analysis is done. | Drug | Boceprevir, PegIFN alfa 2b, Ribavirin |
Primary outcome
Sustained Virologic Response
Time frame: Week 72 or Week 96 (W72 or W96)
HCV-RNA measured 24 weeks after the end of the HCV treatment (W72 or W96)
23 secondary outcomes
HCV viral load
Time frame: W4, W8, W12, W16, W28, W36 and at treatment completion at W48/72
Predictive factors of Sustained virologic Response (SVR)
Time frame: Baseline
HIV virologic endpoints
Time frame: W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48, W60, W72 and W84, W96 if treatment duration is 72 weeks
Residual plasmatic concentration (Cres) of Ribavirin
Time frame: W4 and W8
Hepatic factors: liver fibrosis score
Time frame: Screen, W4, W8, W16, W28, W48, W72, W96.
Alcohol consumption
Time frame: W4, W8, W16, W28, W48, W72, W96
Evaluation of Pharmacokinetic parameters of anti-retroviral treatments
Time frame: Day 0, W8
Clinical and biological adverse events
Time frame: Up to 24 weeks after treatment completion (W72 or W96)
Number of participants classified by virologic failure type: non responder, relapser, null responder
Time frame: W8, W12, W16, W28, W48, W72, W96
ITPA gene polymorphism
Time frame: Day 0
CYP3A4 Polymorphism
Time frame: W8
Maximal Concentration (Cmax) of antiretroviral treatments
Time frame: Day 0 and W8
Area Under the Curve (AUC) of antiretrovirals
Time frame: Day 0 and W8
Insulin resistance
Time frame: at W4, W8, W16, W28, W48, W72, W96
Metabolic syndrome
Time frame: W4, W8, W16, W28, W48, W72, W96
Reasons and dates of treatment discontinuation
Time frame: Up to W72
Perceived symptoms
Time frame: Day 0, W28, W48, W72, W96
French AIDS questionnaire of compliance
Time frame: W0, W28, W48, W72
Tobacco consumption
Time frame: W4, W8, W16, W28, W48, W72, W96
Cannabis consumption
Time frame: W4, W8, W16, W28, W48, W72, W96
Intravenous/nasal drugs consumption
Time frame: W4, W8, W16, W28, W48, W72, W96
Residual Concentration (Cres) of atazanavir boosted or not by ritonavir
Time frame: At screening day, at W48 and in the case of virological rebound
Residual concentration (Cres) of ritonavir
Time frame: At screening day, at W48 and in the case of virological rebound
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 13 Oct 2014.
- Derived from this study: PubMed 27077673Poizot-Martin I, Bellissant E, Garraffo R, Colson P, Piroth L, Solas C, Renault A, Bourliere M, Halfon P, Ghosn J, Alric L, Naqvi A, Carrieri P, Molina JM; ANRS HC27 BOCEPREVIH Study Group. Addition of boceprevir to PEG-interferon/ribavirin in HIV-HCV-Genotype-1-coinfected, treatment-experienced patients: efficacy, safety, and pharmacokinetics data from the ANRS HC27 study. HIV Clin Trials. 2016 Mar;17(2):63-71. doi: 10.1080/15284336.2015.1135553. Epub 2016 Feb 11.
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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.
Isabelle Poizot-Martin, MD principal investigator
University Hospital, Marseille
Eric Bellissant, MD, PhD study chair
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Boceprevir, Peg-interferon alfa 2b and Ribavirin in people with HCV Coinfection and HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.
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 18 inclusion and 24 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 13 Oct 2014. 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 France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Virologic Response (time frame: Week 72 or Week 96 (W72 or W96)). 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 NCT01335529, 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 13 Oct 2014.