Chronic Hepatitis C MedDRA version: 13.1 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations MedDRA version: 13.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations MedDRA version: 13.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations MedDRA version: 13.1 Level: SOC Classif
Conditions
Interventions
Product Name: Boceprevir
Product Code: SCH 503034
Pharmaceutical Form: Capsule
INN or Proposed INN: Boceprevir
CAS Number: 394730-60-0
Current Sponsor code: SCH 503034
Concentration unit: mg milligram
Sponsors
Schering Plough Research Institute, A Division of Schering Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subject must fulfill ALL the criteria listed below for entry: 1. Each subject must be willing and able to provide written informed consent 2. Subject must be =18 and =65 years of age 3. Subject must have a body weight =40 and =125 kg 4. Subject must have a documented history of HIV infection for greater than 6 months prior to Day 1 5. Subject must be on an optimized anti-retroviral treatment regimen (OTR) with stable HIV disease with CD4 =200 cells/mcL and HIV-1 RNA viral load =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Clinical Exclusion Criteria: 1. Prior HCV treatment except herbal remedies must be discontinued except silymarin 2. Coinfected w/ hepatitis B virus or signs/symptoms of infection 3. Decompensated liver disease: ascites, bleeding varices, or hepatic encephalopathy 4. Anti-retroviral regimen change w/in 3 months (except zidovudine, didanosine, stavudine) efavirenz, etravirine, nevirapine & HIV protease inhibitors w/out ritonavir 5. Use of zidovudine, didanosine, stavudine, efavirenz, etravirine, nevirapine w/in 1 month & during the trial 6. Significant opportunistic infections w/in 1yr 7. Diabetic & hypertensive subjects w/ocular findings: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any abnormality 8. Pre-existing psychiatric condition: a. Moderate or severe depression b. Depression associated with: 1) Hospitalization 2) Electroconvulsive Therapy 3) Prolonged work absence or disruption of daily functions c. Suicidal or homicidal ideation/attempt d. Severe psychiatric disorders e. Lithium use f. Antipsychotic drug 9. Substance abuse: alcohol, intravenous drugs, inhalational (not marijuana), psychotropics, narcotics, cocaine, prescription or OTC drugs or history of polysubstance abuse (=3) 10. Clinical diagnosis w/in 6 months of substance abuse Clinical diagnosis requires: a. Documentation w/in 6 months of a low risk for psychiatric exacerbation induced by interferon b. Documentation of compliance by an HIV viral load 10 years ago, an isolated event, no anti-seizure medications prescribed, & a normal neurological examination documented w/in 6 months c. Stroke or transient ischemic attack d. Immunologically-mediated disease e. Chronic pulmonary disease f. Significant cardiac abnormalities/dysfunctions including uncontrolled hypertension, or history of antianginal agents for cardiac conditions g. Conditions requiring, or likely to require, chronic systemic administration of corticosteroids h. Active clinical gout w/in 1 year i. Hemoglobinopathy j. Myelodysplastic syndromes k. Coagulopathy l. Organ transplants other than cornea & hair m. Poor venous access precluding routine blood sampling n. Indwelling venous catheters o. Gastric surgery or malabsorption disorders 14. Malignancy w/in the last 5yrs 15. Subjects pregnant or nursing, who intend to become pregnant, & male subjects w/partners who are, or intend to become pregnant 16. Other conditions unsuitable for enrollment or could interfere w/participating 17. Intent to or participation in other clinical trials w/in 30 days of randomization. Collection of blood, urine, or tissue samples or data, beyond this protocol, is prohibited 18. Treatment w/an investigational drug w/in 30 days of randomization 19. Site personnel involved w/the trial 20. Family members of the trial staff 21. Life-threatening serious adverse event during screening 22. S
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the efficacy of boceprevir (PO) in combination with peginterferon alfa-2b (PEG2b) (SC) plus ribavirin weight-based dosing (WBD) PO to therapy with PEG2b plus ribavirin alone in adult subjects coinfected with human immunodeficiency virus (HIV) and previously untreated chronic hepatitis C virius (HCV) genotype 1.;Secondary Objective: - To evaluate the safety of boceprevir when used in combination with PEG2b/R - To define predictors of SVR such as epidemiologic factors, disease characteristics and on-treatment response - To assess the steady state pharmacokinetics of boceprevir using population-based pharmacokinetic modeling "Key Secondary Trial Objective: The key secondary objective of this trial is to compare the efficacy of boceprevir when used in combination with PEG2b + R (WBD) to the standard of care (PEG2b + R) alone in randomized subjects who received at least one dose of experimental trial medication (Placebo for the control arm and boceprevir for the experimental arm).";Primary end point(s): The primary efficacy endpoint for the trial is: the 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 at FW 12, the subject will be considered a sustained virologic responder. Subjects will be declared treatment failures in one of the following ways: - Subjects in any treatment arm who have detectable HCV-RNA at FW 24 - Subjects in any treatment arm with a <2 log10 decline in HCV-RNA at TW 12 - Subjects in any treatment arm with =LLQ HCV-RNA at TW 24 - Subjects in any treatment arm who are missing their HCV-RNA at or after FW 24 and have detectable or missing HCV-RNA at FW 12 | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Portugal, Spain
Outcome results
None listed