Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access
2017年4月4日 更新者:Bristol-Myers Squibb
Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study
The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS sponsored clinical trial and to collect long-term safety information on the treated population.
研究概览
地位
完全的
条件
详细说明
Provide study drug for patients rolling off BMS ATV clinical trials in countries where these medications are not commercially available.
研究类型
介入性
注册 (实际的)
710
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Moscow、俄罗斯联邦、111123
- Local Institution
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St. Petersburg、俄罗斯联邦、189635
- Local Institution
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St.petersburg、俄罗斯联邦、193167
- Local Institution
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Ontario
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Hamilton、Ontario、加拿大、L8S 4J9
- Local Institution
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Quebec
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Montreal、Quebec、加拿大、H2L 5B1
- Local Institution
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Budapest、匈牙利、1097
- Local Institution
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Eastern Cape
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Port Elizabeth、Eastern Cape、南非、6001
- Local Institution
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Free State
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Bloemfontein、Free State、南非、9301
- Local Institution
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Gauteng
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Johannesburg、Gauteng、南非、2013
- Local Institution
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Meadowdale、Gauteng、南非、1610
- Local Institution
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Westdene、Gauteng、南非、2092
- Local Institution
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Western Cape
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Observatory、Western Cape、南非、7925
- Local Institution
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Rugby、Western Cape、南非、7405
- Local Institution
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Jakarta、印度尼西亚、10430
- Local Institution
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Guatemala、危地马拉
- Local Institution
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Guatemala、危地马拉、01011
- Local Institution
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Guatemala、危地马拉、01016
- Local Institution
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Kaohsiung、台湾、813
- Local Institution
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Taipei、台湾、100
- Local Institution
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Taipei、台湾、108
- Local Institution
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Cundinamarca
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Bogota、Cundinamarca、哥伦比亚
- Local Institution
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Barrio Aranjuez
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San Jose、Barrio Aranjuez、哥斯达黎加、1792
- Local Institution
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Distrito Federal
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Mexico、Distrito Federal、墨西哥、14080
- Local Institution
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Mexico、Distrito Federal、墨西哥、03100
- Local Institution
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Santo Domingo、多明尼加共和国
- Local Institution
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Panama、巴拿马、4746
- Local Institution
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Rio De Janeiro、巴西、21040000
- Local Institution
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Sao Paulo、巴西、01246
- Local Institution
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Parana
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Curitiba、Parana、巴西、80060
- Local Institution
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Curitiba、Parana、巴西、80240
- Local Institution
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Pernambuco
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Recife、Pernambuco、巴西、52052
- Local Institution
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Rio De Janeiro
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Rio De Janeiro - Rj、Rio De Janeiro、巴西、22271
- Local Institution
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Sao Paulo
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Campinas、Sao Paulo、巴西、13083
- Local Institution
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Sao Paulo - Sp、Sao Paulo、巴西、01246
- Local Institution
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Milano、意大利、20127
- Local Institution
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Milano、意大利、20157
- Local Institution
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Modena、意大利、41100
- Local Institution
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Roma、意大利、00185
- Local Institution
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Torino、意大利、10149
- Local Institution
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Singapore、新加坡、308433
- Local Institution
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Metropolitana
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Santiago、Metropolitana、智利
- Local Institution
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Santiago De Chile、Metropolitana、智利
- Local Institution
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Le Kremlin Bicetre、法国、94275
- Local Institution
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Lyon Cedex 02、法国、69288
- Local Institution
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Paris、法国、75020
- Local Institution
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Paris、法国、75014
- Local Institution
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Tourcoing、法国、59208
- Local Institution
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San Juan、波多黎各、00909
- Clinical Research Puerto Rico, Inc.
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San Juan、波多黎各、00927
- V.A. Medical Center
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Bangkok、泰国、10400
- Local Institution
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Bangkok、泰国、10700
- Local Institution
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Bangkok、泰国、10300
- Local Institution
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Chiangmai、泰国、50200
- Local Institution
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Lima、秘鲁、1
- Local Institution
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Lima、秘鲁、31
- Local Institution
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Lima、秘鲁、13
- Local Institution
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Lima、秘鲁、LIMA 14
- Local Institution
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Lima
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Barranco、Lima、秘鲁、4
- Local Institution
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Arizona
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Phoenix、Arizona、美国、85006
- Phoenix Body Positive, Inc
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California
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Los Angeles、California、美国、90033
- Rand Schrader Clinic
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San Francisco、California、美国、94109
- St Francis Memorial Hospital
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Florida
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Miami Beach、Florida、美国、33139
- Sbma Research, Llc
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Tampa、Florida、美国、33607
- St Josephs Cmprhnsv Rsch Inst
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Indiana
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Indianapolis、Indiana、美国、46218
- Infectious Disease Of Indiana, Psc
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Kansas
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Wichita、Kansas、美国、67214
- Univ Of Kansas Sch Of Med
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Massachusetts
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Boston、Massachusetts、美国、02215
- CRI of New England
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Nebraska
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Omaha、Nebraska、美国、68198
- University of Nebraska Medical Center
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North Carolina
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Huntersville、North Carolina、美国、28078
- Jemsek Clinic
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Texas
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Fort Worth、Texas、美国、76104
- Tarrant County Inf Dis Assoc
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Houston、Texas、美国、77098
- The Schrader Clinic
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Lisbon、葡萄牙、1649-035
- Local Institution
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Porto、葡萄牙、4200-319
- Local Institution
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Badalona、西班牙、08915
- Local Institution
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Barcelona、西班牙、08036
- Local Institution
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Bilbao、西班牙、48013
- Local Institution
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Cordoba、西班牙、14004
- Local Institution
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Madrid、西班牙、28034
- Local Institution
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Madrid、西班牙、28046
- Local Institution
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Madrid、西班牙、28040
- Local Institution
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Madrid、西班牙、28029
- Local Institution
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Sevilla、西班牙、41013
- Local Institution
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Buenos Aires、阿根廷、1181
- Local Institution
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Buenos Aires、阿根廷、1155
- Local Institution
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Buenos Aires、阿根廷、1650
- Local Institution
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Buenos Aires、阿根廷、1202
- Local Institution
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Cordoba、阿根廷、X5000BJH
- Local Institution
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Santa Fe
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Rosario、Santa Fe、阿根廷、2000
- Local Institution
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Kuala Lumpur、马来西亚、50586
- Local Institution
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Kuala Lumpur、马来西亚、59100
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Subjects must provide written informed consent
Currently receiving atazanavir (unboosted or boosted with 100 mg ritonavir QD)and/or tenofovir-emtricitabine at time of screening and viral load is
≤ 10,000 copies/mL while on therapy
- Subjects who are receiving investigational antiretroviral agents through Expanded Access Programs will be allowed to participate following discussion and approval by the BMS Medical Monitor
- ≥ 16 years of age (or minimum age as determined by local regulatory or as legal requirements dictate)
- Both females of child-bearing potential and males must utilize effective barrier contraception to reduce transmission of sexually transmitted diseases, including HIV. Other contraception in addition to barrier methods are permitted, however interactions between atazanavir and oral contraceptives have not been studied
Exclusion Criteria:
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study
- WOCBP using a prohibited contraceptive method (no contraceptive methods prohibited in this study. However, caution is warranted with coadministration of oral contraceptives)
- Women who are pregnant or breastfeeding
- Women with a positive pregnancy test on enrollment or prior to study drug administration, with the exception of women rolling over from AI424182, who may still have a positive β-HCG test at the time of enrollment
- All subjects previously discontinued from an atazanavir study for any reason
- Active alcohol or substance abuse sufficient, in the Investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis
- Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for study, or unable to comply with the dosing requirements
- Any of the following laboratory values:
- a) Serum creatinine ≥ 1.5 times the upper limit of normal,
- b) Liver enzymes (AST, ALT) ≥ 5 times the upper limit of normal,
- Hypersensitivity to any component of the formulation of study drug
- Refer to Section 6.4.1 which details all prohibited therapies
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:非随机化
- 介入模型:并行分配
- 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:Atazanavir
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Tablets, Oral, 400 mg, once daily, indefinitely
其他名称:
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实验性的:Atazanavir/Ritonavir
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Tablets, Oral, 300/100 mg, once daily, indefinitely
其他名称:
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有源比较器:Lopinavir/Ritonavir
Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).
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Tablets, Oral, 300/200 mg, once daily, indefinitely
其他名称:
Tablets, Oral, 400/100 mg, twice daily, indefinitely
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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 |
---|---|---|
Number of Participants With Serious Adverse Events (SAEs), Treatment Related SAEs, Treatment Related Adverse Events (AEs), AEs Leading to Discontinuation of Study Therapy, Grade 3 to Grade 4 AEs, Grade 3 to Grade 4 AEs, CDC Class C AIDS Events, or Death
大体时间:Date of First Dose to 30 days post the last dose; approximately 405 weeks)
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AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Treatment-related=having certain, probable, possible, or missing relationship to study drug.
Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling.
AIDS Defining Diagnosis ( CDC Class C AIDS Events) are identified from HIV Related Diagnosis.
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Date of First Dose to 30 days post the last dose; approximately 405 weeks)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2002年10月1日
初级完成 (实际的)
2016年2月1日
研究完成 (实际的)
2016年2月1日
研究注册日期
首次提交
2009年10月20日
首先提交符合 QC 标准的
2009年10月28日
首次发布 (估计)
2009年10月29日
研究记录更新
最后更新发布 (实际的)
2017年5月11日
上次提交的符合 QC 标准的更新
2017年4月4日
最后验证
2017年4月1日
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.
艾滋病病毒的临床试验
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Hospital Clinic of Barcelona完全的
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Centers for Disease Control and PreventionGilead Sciences; CDC Foundation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
Atazanavir的临床试验
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Giovanni Di PerriUniversity of Turin, Italy; University of Milan终止