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正在招募II 期 / III 期编号 NCT07266831

A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)

报名条件(概要)

  • 年龄:18 Years – 不限
  • 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

United States、Argentina、Canada、Chile、France、Guatemala、Mexico、South Africa、Spain

药品与企业信息

ISL药物

其他名称:islatravir、MK-8591

ISL 2 x 1 mg oral capsules administered qw for 96 weeks

ULO药物

其他名称:ulonivirine、MK-8507

ULO 2 x 100 mg oral tablets administered qw for 96 weeks

BIC/FTC/TAF药物

其他名称:bictegravir/emtricitabine/tenofovir alafenamide、BIKTARVY®

BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks

Placebo for BIC/FTC/TAF药物

BIC/FTC/TAF-matching placebo oral tablet administered qd for 96 weeks

Placebo to ISL/ULO药物

ISL/ULO-matching placebo oral tablets administered qw for 96 weeks

ISL/ULO药物

其他名称:MK-8591B

ISL/ULO fixed-dose combination 2 mg/200 mg oral tablet administered qw for 96 weeks

研发企业

Merck Sharp & Dohme LLC企业

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

公开药品批准资料或正式说明书暂未提供明确的生产企业信息。

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)

Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a study ART works as well as a standard ART to treat HIV-1. The study ART combines 2 medicines, islatravir and ulonivirine, and is taken once a week. The goals of this study are to learn: 1) If the study ART works as well as a standard ART to treat HIV-1, and 2) About the safety of the study ART and if people tolerate it compared to a standard ART.

适应症

Human Immunodeficiency Virus Type 1 (HIV-1) 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

  • Ruane Clinical Research Group, Inc. ( Site 1513)Los Angeles,California,United States
  • Vivent Health ( Site 1519)Denver,Colorado,United States
  • Whitman-Walker Institute ( Site 1538)Washington D.C.,District of Columbia,United States
  • Midway Immunology and Research Center ( Site 1503)Ft. Pierce,Florida,United States
  • CAN Community Health- Miami Gardens ( Site 1549)Miami Gardens,Florida,United States
  • Orlando Immunology Center ( Site 1501)Orlando,Florida,United States

问自己是否符合条件、如何预筛

我的病情档案

管理档案

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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: A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
ClinicalTrials.gov Identifier: NCT07266831
Sponsor: Merck Sharp & Dohme LLC
Investigational product: ISL, ULO, BIC/FTC/TAF, Placebo for BIC/FTC/TAF, Placebo to ISL/ULO

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:A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
试验编号:NCT07266831
申办方:Merck Sharp & Dohme LLC
研究药物:ISL、ULO、BIC/FTC/TAF、Placebo for BIC/FTC/TAF、Placebo to ISL/ULO

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 Trialsites@msd.com

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