EUCTR2008-004864-38-DE进行中（未招募）不适用
A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected with HIV and Hepatitis C
Schering Plough Research Institute, A Division of Schering Corporation0 个研究点目标入组 99 人开始时间: 2009年7月13日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 99
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
排除标准
- •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
- 另有 1 项未显示
研究者
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