Kaletra and Maraviroc in Antiretroviral Therapy (ART)-Naive Patients (KALMAR Study) (KALMAR)
Kaletra and Maraviroc in Antiretroviral Therapy-Naïve Patients - KALMAR Study -Version 1.0 Amendment 2
研究概览
详细说明
As patients with HIV are living longer it is important to explore antiretroviral treatments which may reduce the development of long term complications while preserving future HIV treatment options. This trial explores an antiretroviral treatment regimen which does not include the nucleoside reverse transcriptase inhibitor class which is thought to have long-term toxicity. This is a non-randomized, open label trial in participants meeting entry requirements.
Participants will be evaluated at screening, baseline,and weeks 4, 8, 12, 24, 36, and 48 to include clinical assessments as well as laboratory assessments.
An interim analysis will be performed when all patients have reached the week 24 visit.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19140
- Temple General Internal Medicine
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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:
- The patient has signed and dated approved informed consent form.
- There is confirmed laboratory diagnosis of HIV infection (positive ELISA HIV antibody test confirmed by Western blot, p24 antigen assay, quantitative HIV-1 RNA assay, or HIV culture).
- The patient is at least 18 years of age.
- ART-naïve, lopinavir/ritonavir susceptible on genotypic testing, CCR5-tropic virus on Trofile testing (ESTA).
- Negative pregnancy test within 72 hours prior to start of study for women of childbearing potential.
- Females of childbearing potential and males must utilize effective barrier contraception.
- HIV RNA greater than 1,000 copies per mL at entry.
- Liver enzymes (AST, ALT) < 3 times the upper limit of normal.
Exclusion Criteria:
- Patients who are pregnant or breast-feeding.
- Active alcohol or substance abuse sufficient, in the Investigator's opinion that makes compliance to the study protocol unlikely.
- Suspected or active HIV-related opportunistic infection or condition requiring acute therapy within 30 days of entry into the trial.
- Patients on therapy for hepatitis B.
- Patients with hepatitis B surface antigen, or any evidence of active hepatitis B such as positive hepatitis B DNA and/or presence of hepatitis e antigen or e antibody.
- Acute hepatitis B or C within 60 days of entry.
- Patients harboring preexistent co-receptor CXCR4 tropic or dual-or mixed-tropic HIV.
- Patients harboring HIV resistant to lopinavir/ritonavir on genotypic testing.
- The presence of decompensated heart failure, myocardial infarction within 1 year, bypass surgery, severe vascular disease, or active hepatobiliary disease.
- Concomitant use of rifampin, ergot derivatives (i.e. dihydroergotamine, ergotamine), cisapride, lovastatin, simvastatin, triazolam, orally administered midazolam, carbamazepine, phenytoin, St. John's wort, ketoconazole, itraconazole, clarithromycin, telithromycin, amiodarone, bepridil, flecainide, propafenone, quinidine, voriconazole or nefazodone.
- Patients with concomitant diagnosis of malignancy or cancer other than basal cell carcinoma within the past 5 years.
- Concomitant use of investigational agents including the use of any investigational vaccines.
- Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study, or unable to comply with the dosing requirements.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:open label single arm
Drug: lopinavir/ritonavir plus maraviroc
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Lopinavir/ritonavir 400 mg/100 mg two tablets twice daily with Maraviroc 150 mg one tablet twice daily will be administered for 48 weeks to participants meeting entry criteria.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Assess Proportion of Participants With HIV RNA Levels <50 and < 400 Copies/mL.
大体时间:week 48
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week 48
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次要结果测量
结果测量 |
大体时间 |
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Number of Participants With HIV RNA < 50 and <400 Copies/ml.
大体时间:week 24
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week 24
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Assess the Proportion of Participants at Study Termination With VL < 50 Copies/ml.
大体时间:week 48
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week 48
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Determine the Time to Viral Suppression (VL < 50 Copies/ml).
大体时间:48 weeks
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48 weeks
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Determine the Median Change in VL From Baseline to Week 24, to Week 48 and to Study Termination.
大体时间:week 24, week 48
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week 24, week 48
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Assess the Changes in CD4+ T Cell Count.
大体时间:week 24, 48
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week 24, 48
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Assess Development of HIV Resistance Mutations and in HIV Co-receptor Tropism Changes in Participants Who Develop Virologic Rebound.
大体时间:week 48
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week 48
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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 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Temple IRB 12848
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.
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