新新药通
返回搜索
正在招募不适用编号 NCT07497594

ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention

报名条件（概要）

  • 年龄：16 Years – 30 Years
  • 性别：不限
  • 健康志愿者：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

Lenacapavir long-acting药物

Approximately 1200 participants who choose long acting Lenacapavir will receive an oral loading dose consisting of 600 milligrams on Day 1 and 600 milligrams on Day 2, followed by 300 milligrams on Day 8, according to the clinical protocol, followed by subcutaneous administration of Lenacapavir at a dose of 927 milligrams per injection, administered at the enrollment visit and repeated every six months, totaling up to four administrations during the follow up period, combined with regular clinical visits for safety assessment, human immunodeficiency virus testing, monitoring of adverse events and serious adverse events, evaluation of injection site reactions, combined prevention counseling, screening and management of sexually transmitted infections, hepatitis B and hepatitis C, and monitoring of adherence to the injection schedule

Tenofovi-Emtricitabine (TDF/FTC) tablet药物

Approximately 300 participants who choose oral human immunodeficiency virus pre exposure prophylaxis will receive oral tenofovir disoproxil fumarate 300 milligrams combined with emtricitabine 200 milligrams in a fixed dose combination administered once daily on a continuous basis, with regular medication dispensing, periodic clinical follow up, serial human immunodeficiency virus testing, monitoring of adverse events, assessment of self reported adherence, combined prevention counseling, and screening and management of sexually transmitted infections and viral hepatitis, for up to 24 months of follow up

研发企业

Oswaldo Cruz Foundation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

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）

The goal of this study is to learn how well long-acting lenacapavir works to prevent human immunodeficiency virus (HIV) infection in people at higher risk of getting HIV in Brazil. The study will also learn about safety, continued use over time, and whether people prefer this option compared to daily oral pre- exposure prophylaxis (PrEP). The main questions it aims to answer are: How many participants get HIV while using long-acting lenacapavir? How safe is long-acting lenacapavir in real-world health services? How many participants continue using their chosen prevention method over time? What factors help or make it harder for participants to stay on prevention? Researchers will compare two HIV prevention options to understand how they work in routine care: Long-acting lenacapavir, given as an injection under the skin every 6 months, Daily oral pre-exposure prophylaxis (PrEP), taken as a pill containing tenofovir disoproxil fumarate and emtricitabine, Participants will choose the prevention option they prefer after receiving counseling. This is not a randomized study. Researchers will follow participants for up to 2 years. Participants will: Receive either an injection every 6 months or take a daily pill, Visit the clinic regularly for HIV testing and health checkups, Receive testing and treatment for sexually transmitted infections, Answer questions about their health, medication use, and experiences, Receive prevention counseling and condoms. This study will help health services understand how to offer long-acting HIV prevention in Brazil and how to better support people who want to prevent HIV infection.

适应症

Contact With or Exposure to Human Immunodeficiency Virus

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: ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention
ClinicalTrials.gov Identifier: NCT07497594
Sponsor: Oswaldo Cruz Foundation
Investigational product: Lenacapavir long-acting, Tenofovi-Emtricitabine (TDF/FTC) tablet

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：ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention
试验编号：NCT07497594
申办方：Oswaldo Cruz Foundation
研究药物：Lenacapavir long-acting、Tenofovi-Emtricitabine (TDF/FTC) tablet

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 gbeatriz@ini.fiocruz.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