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正在招募II 期编号 NCT06805656

Multi Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without Antiretrovirals

报名条件(概要)

  • 年龄:18 Years – 65 Years
  • 性别:不限
  • 健康志愿者:不接受

完整入排标准请以官方页面为准。

开展国家/地区

Brazil

药品与企业信息

Maraviroc药物

其他名称:Selzentry、Celsentri

antiretroviral intensification

其他名称:Tivicay

antiretroviral intensification

Dendritic Cell Vaccine生物制品

其他名称:DC Vaccine

therapeutic vaccination

Auranofin药物

其他名称:Gold Salt

purging

Sirtuin Histone deacetylase inhibitor药物

其他名称:Nicotinamide

latency disruption

研发企业

Federal University of São Paulo研究机构/其他

试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。

生产企业

Dolutegravir

ST. MARY'S MEDICAL PARK PHARMACY

Auranofin

Coral Way Pharma, LLC

合作机构

  • Conselho Nacional de Desenvolvimento Científico e TecnológicoOTHER_GOV
  • Weill Medical College of Cornell University研究机构/其他
  • Fundação de Amparo à Pesquisa do Estado de São PauloOTHER_GOV

研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。

研究简介(原文)

A modern and urgent challenge in fighting HIV infection is to achieve sustained HIV remission without the use of antiretrovirals. The investigators' preliminary data indicate that the use of combined strategies to mitigate the HIV proviral reservoir size among individuals with suppressive antiretroviral treatment achieved unprecedented results in the reduction of HIV DNA present in these cells and in the reduction of CD4 + and CD8 + T cell activation. Combined interventions include intensified antiretroviral treatment to mitigate residual HIV replication, use of a histone deacetylase inhibitor to interrupt viral latency, use of an anti-proliferative medication to reduce long-lived T cells that harbor HIV and a personalized dendritic cell therapy vaccine to eliminate cells with latent HIV infection or cells present in viral sanctuaries. Due to the good results obtained in the exploratory stage of the project, the investigators propose to expand it by recruiting a larger number of patients to confirm the previously obtained results and to generate new insights related to the mechanisms involved in viral latency, latency disruption and the effects of analytical treatment interruption of antiretrovirals among patients undergoing all above mentioned interventions.

适应症

HivHIV I Infection

主动联系研究团队

这项试验目前在中国大陆没有研究中心

这种情况下,直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药/扩展准入(由主治医生一同提出),或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。

查看完整申请路径与成功率说明 →

总联系人(申办方/研究总部)

研究中心联系方式

问自己是否符合条件、如何预筛

我的病情档案

管理档案

档案只保存在您自己的浏览器里,不会上传,任何人(包括本站)都看不到。

英文版(发给研究团队)

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: Multi Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without Antiretrovirals
ClinicalTrials.gov Identifier: NCT06805656
Sponsor: Federal University of São Paulo
Investigational product: Maraviroc, Dolutegravir, Dendritic Cell Vaccine, Auranofin, Sirtuin Histone deacetylase inhibitor

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照(供您核对)

尊敬的研究团队:

我是一位来自中国的患者,希望咨询参加以下临床试验的可能:

研究名称:Multi Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without Antiretrovirals
试验编号:NCT06805656
申办方:Federal University of São Paulo
研究药物:Maraviroc、Dolutegravir、Dendritic Cell Vaccine、Auranofin、Sirtuin Histone deacetylase inhibitor

我的基本情况:
- 年龄:(请填写)
- 性别:(请填写)
- 确诊疾病与分期:(请填写)
- 基因/标志物检测:暂无
- 既往及当前治疗:(请填写)
- 体能状态(ECOG):未评估
- 目前所在城市:中国
- 可前往范围:(请填写)

想请教三个问题:
1. 我是否可能符合本研究的入组标准?
2. 哪个中心对我最方便可行?能否远程预筛?
3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)?

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
(您的姓名)
(您的邮箱/带国际区号的电话)
用邮件客户端发送给 rsdiaz@catg.com.br

提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。

下一步怎么做?

  1. 把本页信息带给您的主治医生,评估是否适合参加。
  2. 点击下方按钮打开官方注册页,查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。
在 ClinicalTrials.gov 查看官方页面