Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: testing Lenacapavir long-acting for Contact With or Exposure to Human Immunodeficiency Virus

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).

Official registry: https://clinicaltrials.gov/study/NCT07497594 · Oswaldo Cruz Foundation · enrollment listed as 1,500

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Lenacapavir long-acting, or Tenofovi-Emtricitabine (TDF/FTC) tablet. The registry lists allocation as randomized. 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.

They plan to enroll about 1,500 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Expanding PrEP Options Among Young MSM, Transgender and Non-binary Persons in Brazil: Incorporating Twice-yearly Lenacapavir for HIV Prevention - The ImPrEP LEN Brasil Study

Interventions: Lenacapavir long-acting, Tenofovi-Emtricitabine (TDF/FTC) tablet

Primary outcome (registry wording): Proportion of participants who remain persistent on Lenacapavir pre-exposure prophylaxis at 24 months

Who it is for (from inclusion criteria)

  • Ages 16 Years to 30 Years
  • Be a cisgender man, a non-binary person designated male at birth, or a transgender woman or transgender man
  • Report having engaged in anal sex with a person designated male at birth within the last six months
  • Be between 16 and 30 years of age
  • Have a body weight equal to or greater than 35 kilograms
  • Seek care at a participating study clinic for human immunodeficiency virus testing or initiation of human immunodeficiency virus pre-exposure prophylaxis, either spontaneously or through peer invitation
  • Have a non-reactive result on a rapid test for human immunodeficiency virus
  • Be an individual without prior use of human immunodeficiency virus pre-exposure prophylaxis, or an individual with prior use who remains in a situation of vulnerability, characterized by:

Public study contact (from the registry)

Beatriz Grinsztejn, PhD

+55 2138659128

gbeatriz@ini.fiocruz.br

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

8 listed

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FAQ about this NCT record

Is NCT07497594 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07497594?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07497594?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary