Kaletra Monotherapy in HIV/HCV Co-infected Subjects
A Pilot, Prospective, Open-label Study to Evaluate the Safety and Efficacy of Kaletra® Monotherapy in HIV/HCV Co-infected Subjects.
研究概览
详细说明
The primary purpose of this study is to determine how safe and effective the drug Kaletra® is in treating HIV when it is administered without any other antiretroviral drugs (monotherapy). Kaletra® is 2 protease inhibitors (lopinavir and ritonavir) combined in one dosage form.
Kaletra monotherapy is experimental and subjects eligible to the study are switching from a successful conventional triple therapy to an unproven experimental therapy.
Approximately 40 HIV/HCV coinfected participants, aged over 18 years will participate in this study.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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British Columbia
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Vancouver、British Columbia、加拿大、V6Z 2C7
- University of British Columbia
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Ontario
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Ottawa、Ontario、加拿大、K1H 8L6
- The Ottawa Hospital, General Campus
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
- Subject has confirmed his or her willingness to participate in the study after being informed of all aspects of the trial that are relevant to his or her decision to participate, by signing and dating the IRB / IEC approved informed consent form.
- Subject is both HIV positive and HCV positive (must be viremic for HCV, not just antibody positive).
- Subject is 18 years of age or older.
- Subject must have an undetectable viral load (VL) less than 50 copies/ml for the last 6 months on HAART therapy.
- Subject must not be taking any medication that could interact with Kaletra® to enhance hepatic toxicity.
- Subject's serum AST and ALT levels must be <5 times normal (grade 2 or less) at the start of the study.
- Subject must not harbour viral strains that are resistant to Kaletra® at the start of the study.
- Subject has a Karnofsky Score 70 or greater.
- If female, subject must have a negative pregnancy test and agree to use, for the duration of the study, a barrier method of birth control that has a history of proven reliability as judged by the investigator.
- Subject does not require and agrees not to take, for the duration of the study, any medication that is contraindicated with Kaletra® (list will be in the protocol).
Exclusion Criteria
- Subject has active hepatitis B (HbsAg +).
- Subject has a history of substance abuse or psychiatric illness that could preclude compliance with the protocol.
Subject has any of the following abnormal laboratory test results at screening:
- Hemoglobin 8.0 g/dL or more
- Absolute neutrophil count 500 cells/mL or more
- Platelet count 20,000/mL or more
- ALT or AST 5x Upper Limit of Normal (ULN) or more
- Creatinine 1.5 x ULN or more
- Female subject is pregnant or lactating.
- Subject has received an investigational drug within 30 days prior to the initiation of study dosing.
- Subject exhibits viral strains that are resistant to lopinavir.
- Subject is receiving systemic chemotherapy.
- The subject, in the opinion of the principal investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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The primary objective of this study is to assess the safety and efficacy of Kaletra® (lopinavir/ritonavir) monotherapy in the treatment of patients co-infected with HIV and HCV.
大体时间:48 weeks
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patients on cART switched to Kaletra monotherapy an monitored for 48 weeks thereafter
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48 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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To investigate and compare the pharmacokinetics (PK) of Kaletra® monotherapy at steady-state between co-infected subjects with advanced liver fibrosis (stage 3-4) and those with minimal liver disease (stage 0-2)
大体时间:24 weeks
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PK measured at week 4 and 24
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24 weeks
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To study compliance of subjects
大体时间:48 weeks
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adherence assessed at each study visit
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48 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
艾滋病毒感染的临床试验
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Hospital Clinic of Barcelona完全的
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Rajavithi Hospital未知研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的免疫状态 | 研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的 HIV 病毒载量泰国
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National Institute of Allergy and Infectious Diseases...完全的HIV-1 感染 | HIV抗体 | 中和抗体 | 病毒载量 | 单克隆抗体美国
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AIDS Healthcare FoundationUniversity of California, Los Angeles完全的
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ANRS, Emerging Infectious DiseasesInstitut National de la Santé Et de la Recherche Médicale, France; University of Bergen; Centre... 和其他合作者完全的
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Hospital Universitari Vall d'Hebron Research InstituteGilead Sciences完全的
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Hospital Universitari Vall d'Hebron Research InstituteUniversity Hospital, Ghent; IrsiCaixa完全的
Kaletra Tablets的临床试验
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Fundacion SEIMC-GESIDAAbbott完全的
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Therapeutic ConceptsAbbott; Tibotec, Inc; BluKyne完全的
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University of California, San Francisco完全的