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Boceprevir in HIV-HCV Coinfected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin (BocepreVIH)

Primary Purpose

HCV Coinfection, HIV-1 Infection

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Boceprevir, Peg-interferon alfa 2b and Ribavirin
Sponsored by
ANRS, Emerging Infectious Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HCV Coinfection focused on measuring HCV infection, HIV-1 infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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:

    • 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.

Exclusion Criteria:

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.

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

Sites / Locations

  • CHU Sainte Marguerite

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Boceprevir, PegIFN alfa 2b, Ribavirin

Arm Description

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

Outcomes

Primary Outcome Measures

Sustained Virologic Response
HCV-RNA measured 24 weeks after the end of the HCV treatment (W72 or W96)

Secondary Outcome Measures

HCV viral load
HCV-RNA
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
HIV virologic endpoints
HIV-RNA CD4 and CD8 count
Residual plasmatic concentration (Cres) of Ribavirin
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).
Alcohol consumption
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.
Clinical and biological adverse events
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
ITPA gene polymorphism
The relation between ITPA gene polymorphism and onset of haemolytic anaemia will be analysed.
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.
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.
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.
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).
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).
Reasons and dates of treatment discontinuation
Perceived symptoms
Perceived symptoms will be assessed on "AC24 French AIDS scale"
French AIDS questionnaire of compliance
Tobacco consumption
Cannabis consumption
Intravenous/nasal drugs consumption
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).
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).

Full Information

First Posted
March 25, 2011
Last Updated
October 10, 2014
Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Rennes University Hospital, Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01335529
Brief Title
Boceprevir in HIV-HCV Coinfected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin
Acronym
BocepreVIH
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Rennes University Hospital, Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCV Coinfection, HIV-1 Infection
Keywords
HCV infection, HIV-1 infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Boceprevir, PegIFN alfa 2b, Ribavirin
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Boceprevir, Peg-interferon alfa 2b and Ribavirin
Other Intervention Name(s)
ViraferonPeg, Rebetol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sustained Virologic Response
Description
HCV-RNA measured 24 weeks after the end of the HCV treatment (W72 or W96)
Time Frame
Week 72 or Week 96 (W72 or W96)
Secondary Outcome Measure Information:
Title
HCV viral load
Description
HCV-RNA
Time Frame
W4, W8, W12, W16, W28, W36 and at treatment completion at W48/72
Title
Predictive factors of Sustained virologic Response (SVR)
Description
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
Time Frame
Baseline
Title
HIV virologic endpoints
Description
HIV-RNA CD4 and CD8 count
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
Title
Residual plasmatic concentration (Cres) of Ribavirin
Time Frame
W4 and W8
Title
Hepatic factors: liver fibrosis score
Description
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).
Time Frame
Screen, W4, W8, W16, W28, W48, W72, W96.
Title
Alcohol consumption
Time Frame
W4, W8, W16, W28, W48, W72, W96
Title
Evaluation of Pharmacokinetic parameters of anti-retroviral treatments
Description
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.
Time Frame
Day 0, W8
Title
Clinical and biological adverse events
Time Frame
Up to 24 weeks after treatment completion (W72 or W96)
Title
Number of participants classified by virologic failure type: non responder, relapser, null responder
Description
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
Time Frame
W8, W12, W16, W28, W48, W72, W96
Title
ITPA gene polymorphism
Description
The relation between ITPA gene polymorphism and onset of haemolytic anaemia will be analysed.
Time Frame
Day 0
Title
CYP3A4 Polymorphism
Description
Evaluation of Pharmacokinetic parameters (Cres, Cmax, AUC) of Boceprevir at W8 in a sub-group of subjects, according to antiretroviral treatment and CYP3A4 polymorphism.
Time Frame
W8
Title
Maximal Concentration (Cmax) of antiretroviral treatments
Description
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.
Time Frame
Day 0 and W8
Title
Area Under the Curve (AUC) of antiretrovirals
Description
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.
Time Frame
Day 0 and W8
Title
Insulin resistance
Description
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).
Time Frame
at W4, W8, W16, W28, W48, W72, W96
Title
Metabolic syndrome
Description
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).
Time Frame
W4, W8, W16, W28, W48, W72, W96
Title
Reasons and dates of treatment discontinuation
Time Frame
Up to W72
Title
Perceived symptoms
Description
Perceived symptoms will be assessed on "AC24 French AIDS scale"
Time Frame
Day 0, W28, W48, W72, W96
Title
French AIDS questionnaire of compliance
Time Frame
W0, W28, W48, W72
Title
Tobacco consumption
Time Frame
W4, W8, W16, W28, W48, W72, W96
Title
Cannabis consumption
Time Frame
W4, W8, W16, W28, W48, W72, W96
Title
Intravenous/nasal drugs consumption
Time Frame
W4, W8, W16, W28, W48, W72, W96
Title
Residual Concentration (Cres) of atazanavir boosted or not by ritonavir
Description
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).
Time Frame
At screening day, at W48 and in the case of virological rebound
Title
Residual concentration (Cres) of ritonavir
Description
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).
Time Frame
At screening day, at W48 and in the case of virological rebound

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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. Exclusion Criteria: 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Poizot-Martin, MD
Organizational Affiliation
University Hospital, Marseille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Bellissant, MD, PhD
Organizational Affiliation
Rennes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
CHU Sainte Marguerite
City
Marseille
ZIP/Postal Code
13009
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27077673
Citation
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.
Results Reference
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Boceprevir in HIV-HCV Coinfected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin

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