Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Individuals
2021年11月22日 更新者：Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1-infected Individuals
To find out if it is possible for HIV-1 patients to maintain antiretroviral medications during allogeneic bone marrow transplant
研究概览
详细说明
Determine the feasibility of maintaining optimal ART in HIV-1 infected patients during allogeneic hematopoietic stem cell transplant (HSCT).
The primary outcome is the fraction of patients who maintain any form of anti-retroviral therapy, including enfuvirtide monotherapy, through day 60 post-transplant.
If patients are unable to take oral anti-retroviral medications, but are able to tolerate subcutaneous enfuvirtide monotherapy this will be considered maintenance of ART.
Failure to maintain ART will be defined as ≥ 24 hours without any anti-retroviral therapy.
研究类型
介入性
注册 (实际的)
11
阶段
- 第一阶段早期
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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Maryland
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Baltimore、Maryland、美国、21287
- The Sidney Kimmel Comprehensive Cancer Center
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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
18年 及以上 (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:
- HIV-1 infection, as documented by a rapid HIV-1 test or any FDA-approved HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit and confirmed by western blot at any time prior to study entry. Alternatively, two HIV-1 RNA values > 200 copies/mL at least 24 hours apart performed by any laboratory that has CLIA certification, or its equivalent may be used to document infection.
- Patients must be ≥ 18 years of age.
- Plan to undergo a Myeloablative, HLA matched or partially HLA-mismatched (haploidentical), related-donor bone marrow transplantation that includes high-dose posttransplantation Cy using bone marrow from a related donor:
- Plan to undergo a Nonmyeloablative, HLA matched or partially HLA-mismatched, related-donor bone marrow transplantation that includes high-dose posttransplantation Cy using bone marrow from a related donor:
Exclusion Criteria:
- Patients with a known history of enfuvirtide resistance will not be eligible for this trial.
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：基础科学
- 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：Enfuvirtide monotherapy
Enfuvirtide 90 mg subcutaneously every 12 hours will be also be administered during any periods when oral medications are not expected to be tolerated for ≥ 24 hours, or during periods when ART is held due to interactions with conditioning regimens in patients who require ritonavir-boosted PI containing ART regimens.
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Enfuvirtide 90 mg subcutaneously twice daily will be administered to all patients on day 3 and 4 post-transplant and during any periods when oral medications are not expected to be tolerated for ≥ 24 hours, or during periods when ART is held due to interactions
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 |
措施说明 |
大体时间 |
|---|---|---|
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Determine the feasibility of maintaining optimal ART in HIV-1 infected patients during allogeneic HSCT
大体时间：24 hours
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Failure to maintain anti retroviral therapy for 24 hours
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24 hours
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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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Number of copies of HIV-1 DNA in blood mononuclear cells at baseline
大体时间：Baseline
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Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells.
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Baseline
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Number of copies of HIV-1 DNA in blood mononuclear cells at 12 weeks
大体时间：12 weeks post-intervention
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Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells.
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12 weeks post-intervention
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Number of copies of HIV-1 DNA in blood mononuclear cells at 24 weeks
大体时间：24 weeks post-intervention
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Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells.
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24 weeks post-intervention
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Number of copies of HIV-1 DNA in blood mononuclear cells at 36 weeks
大体时间：36 weeks post-intervention
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Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells.
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36 weeks post-intervention
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Number of copies of HIV-1 DNA in blood mononuclear cells at 52 weeks
大体时间：52 weeks post-intervention
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Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells.
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52 weeks post-intervention
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Number of copies of HIV-1 DNA in blood mononuclear cells at 2 years
大体时间：2 years post-intervention
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Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells.
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2 years post-intervention
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The incidence of acute graft-vs-host disease
大体时间：2 years post-intervention
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Describe the incidence of acute graft-vs-host disease via the Keystone criteria
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2 years post-intervention
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The severity of acute graft-vs-host disease
大体时间：2 years post-intervention
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Describe the severity of acute graft-vs-host disease via the Keystone criteria
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2 years post-intervention
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The incidence of chronic graft-vs-host disease as defined by the NIH consensus criteria
大体时间：2 years post-intervention
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Describe the incidence chronic graft-vs-host disease via the NIH consensus criteria.
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2 years post-intervention
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The incidence of chronic graft-vs-host disease as defined by the Seattle criteria
大体时间：2 years post-intervention
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Describe the incidence chronic graft-vs-host disease via the Seattle criteria.
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2 years post-intervention
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The severity of chronic graft-vs-host disease as defined by the NIH consensus criteria
大体时间：2 years post-intervention
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Describe the severity of chronic graft-vs-host disease via the NIH consensus criteria and the Seattle criteria
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2 years post-intervention
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The severity of chronic graft-vs-host disease as defined by the Seattle criteria
大体时间：2 years post-intervention
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Describe the severity of chronic graft-vs-host disease via the Seattle criteria
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2 years post-intervention
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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。
调查人员
- 首席研究员：Richard Ambinder, M.D., Ph.D.、Johns Hopkins University
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。
一般刊物
- Capoferri AA, Redd AD, Gocke CD, Clark LR, Quinn TC, Ambinder RF, Durand CM. Brief Report: Rebound HIV Viremia With Meningoencephalitis After Antiretroviral Therapy Interruption After Allogeneic Bone Marrow Transplant. J Acquir Immune Defic Syndr. 2022 Mar 1;89(3):297-302. doi: 10.1097/QAI.0000000000002862.
- Capoferri AA, Redd AD, Gocke CD, Clark LR, Ambinder RF, Durand CM. Short Communication: Persistence of HIV After Allogeneic Bone Marrow Transplant in a Dually Infected Individual. AIDS Res Hum Retroviruses. 2022 Jan;38(1):33-36. doi: 10.1089/AID.2021.0047. Epub 2021 Jul 5.
- Durand CM, Capoferri AA, Redd AD, Zahurak M, Rosenbloom DIS, Cash A, Avery RK, Bolanos-Meade J, Bollard CM, Bullen CK, Flexner C, Fuchs EJ, Gallant J, Gladstone DE, Gocke CD, Jones RJ, Kasamon YL, Lai J, Levis M, Luznik L, Marr KA, McHugh HL, Mehta Steinke S, Pham P, Pohlmeyer C, Pratz K, Shoham S, Wagner-Johnston N, Xu D, Siliciano JD, Quinn TC, Siliciano RF, Ambinder RF. Allogeneic bone marrow transplantation with post-transplant cyclophosphamide for patients with HIV and haematological malignancies: a feasibility study. Lancet HIV. 2020 Sep;7(9):e602-e610. doi: 10.1016/S2352-3018(20)30073-4. Epub 2020 Jul 7.
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 (实际的)
2013年6月1日
初级完成 (实际的)
2020年1月22日
研究完成 (实际的)
2021年6月5日
研究注册日期
首次提交
2013年4月16日
首先提交符合 QC 标准的
2013年4月18日
首次发布 (估计)
2013年4月19日
研究记录更新
最后更新发布 (实际的)
2021年11月23日
上次提交的符合 QC 标准的更新
2021年11月22日
最后验证
2021年6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.