A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected with HIV and Hepatitis C - ND
- Conditions
- Chronic Hepatitis CMedDRA version: 9.1 Level: LLT Classification code 10008912
- Registration Number
- EUCTR2008-004864-38-IT
- Lead Sponsor
- Schering Plough Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 99
1. Subject must be ≥18 and ≤65 years of age 2. Subject must have a body weight ≥40 and ≤125 kg 3. Subject must have a documented history of HIV infection for greater than 6 months prior to Day 1 4. 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 <50 copies/mL 5. Subject must have documented CHC genotype 1 infection (HCV infection greater than 6 months prior to Day 1). Subjects with other or mixed genotypes are not eligible. The HCV-RNA result obtained at the Screening Visit must confirm genotype 1 infection and be ≥10,000 IU/mL 6. Subject must have a liver biopsy with histology consistent with CHC and no other etiology. Copies of the pathology report and histology slides (suitable for evaluation by the trial central pathologist) are required for the subject to be included in the trial. The trial site must be able to access the pathology report and histology slides prior to subject randomization. Two unstained slides are preferred; however, one slide stained with hematoxylin plus eosin (H and E) plus one slide stained with Massons trichrome will be accepted (slides should be reviewed by the investigator to confirm adequacy). The central pathologists reading will be used for analysis purposes only; randomization will be performed based on the local report a. If no cirrhosis is present: The liver biopsy must be within 2 years of the Screening Visit b. If cirrhosis is present: Any historic liver biopsy demonstrating cirrhosis will be accepted regardless of the length of time since biopsy. Refer to Appendix 1 for the Scoring Systems for Hepatic Fibrosis c. If the timing of the liver biopsy does not meet the criteria outlined in Inclusion Criteria Nos. 6a and 6b, a liver biopsy may be performed between Screening and Day 1 (only if the subjects Screening Visit confirms that the subject meets the other trial inclusion criteria) 7. Subject with bridging fibrosis or cirrhosis must have an ultrasound within 6 months of the Screening Visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC) 8. Subject and subjects heterosexual 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 trial medication, or longer if dictated by local regulations
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Prior HCV treatment other than herbal remedies must be discontinued before Day 1, except silymarin. 2. Coinfected with hepatitis B virus &/or signs & symptoms consistent with infection 3. Decompensated liver disease: ascites, bleeding varices, or hepatic encephalopathy 4. Anti-retroviral regimen change w/in 3 months (except zidovudine, didanosine, stavudine & HIV protease inhibitors w/out ritonavir) 5. Use of zidovudine, didanosine or stavudine w/in 1 month & during the trial 6. Significant opportunistic infections w/in 1yr 7. Substance abuse of alcohol, intravenous drugs, inhalational (not marijuana), psychotropics, narcotics, cocaine, prescription or over-the-counter drugs or history of polysubstance abuse (≥3) 8. Clinical diagnosis w/in the past 6 months of substance abuse Clinical diagnosis requires: a. Documentation w/in the past 6 months of a low risk for psychiatric exacerbation induced by interferon b. Documentation of compliance by an HIV viral load <400 copies/mL for ≥ 1yr 9. Receiving opiate agonist substitution therapy but not in a substitution maintenance program 10. Marijuana use deemed excessive or interfering w/subject`s life. Subject instructed to stop use of recreational marijuana prior to the trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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;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.
- Secondary Outcome Measures
Name Time Method