A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected with HIV and Hepatitis C
- Conditions
- Chronic Hepatitis CMedDRA version: 9.1Level: LLTClassification code 10008912Term: Chronic hepatitis CMedDRA version: 9.1Level: PTClassification code 10019744Term: <Manually entered code. Term in E.1.1>MedDRA version: 9.1Level: SOCClassification code 10021881Term: <Manually entered code. Term in E.1.1>MedDRA version: 9.1Level: SOCClassification code 10019805Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2008-004864-38-NL
- Lead Sponsor
- Schering Plough Research Institute, A Division of Schering Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 99
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
Clinical Exclusion Criteria:
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. Diabetic & hypertensive subjects w/ ocular examination findings: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any significant 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 use for conditions listed in 8d
9. Substance abuse of alcohol, intravenous drugs, inhalational (not marijuana), psychotropics, narcotics, cocaine, prescription or over-the-counter drugs or history of polysubstance abuse (=3)
10. 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
11. Receiving opiate agonist substitution therapy but not in a substitution maintenance program
12. Marijuana use deemed excessive or interfering w/subject's life. Subject instructed to stop use of recreational marijuana prior to the 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. Clinically significant cardiac abnormalities/dysfunctions including uncontrolled hypertension, or history of antianginal agents for cardiac conditions
g. Medical 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 peripheral blood sampling
n. Indwelling venous catheters
o. Gastric surgery or malabsorption disorders
14. Malignancy w/in the last 5yrs
15. Subjects who are pregnant or nursing, who intend to become pregnant, & male subjects with partners who are, or intend to become pregnant
16. Other conditions unsuitable for enrollment or could interfere with 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 that specified in this protocol, is prohibited
18. Treatment w/an investigational drug w/in 30 days of r
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method