A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected with HIV and Hepatitis C

• Conditions: Chronic Hepatitis C; MedDRA version: 13.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 13.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 13.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 13.1Level: SOCClassification code 10019805Term: Hepatobiliary disordersSystem Organ Class: 10019805 - Hepatobiliary disorders

• Registration Number: EUCTR2008-004864-38-DE
• Lead Sponsor: Schering Plough Research Institute, A Division of Schering Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-13
• Last Update Posted: 15 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 99

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 <50
copies/mL
6. 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
7. 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 Masson’s trichrome will be accepted (slides should
be reviewed by the investigator to confirm adequacy). The central
pathologist’s 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. 7a and 7b, a liver biopsy may be performed
between Screening and Day 1 (only if the subject’s Screening Visit
confirms that the subject meets the other trial inclusion criteria)
8. 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)
9. Subject and subject’s 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

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 <400 copies/mL for = 1yr
11. Receiving opiate agonist substitution therapy but not in a substitution maintenance program
12. Marijuana deemed excessive or interfering w/subject's life. Stop use of recreational marijuana prior to trial
13. Pre-existing medical condition interfering with participation
a. Central nervous system trauma requiring intubation, intracranial pressure monitoring, brain meningeal or skull surgery, or resulting in seizure, coma, permanent neurologic deficits, abnormal brain imaging, cerebrospinal fluid
leak, or prior brain hemorrhage and/or intracranial aneurysms
b. Seizure disorder unless seizure was >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified