Contact With or Exposure to Human Immunodeficiency VirusImPrEP LENNCT07497594
ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention
A study testing Lenacapavir long-acting and Tenofovi-Emtricitabine (TDF/FTC) tablet in people with Contact With or Exposure to Human Immunodeficiency Virus, run by Oswaldo Cruz Foundation at 8 sites in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact With or Exposure to Human Immunodeficiency Virus
- What is being tested?
- Lenacapavir long-acting and Tenofovi-Emtricitabine (TDF/FTC) tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 8 sitesBrazil
- Study dates
- 3 Feb 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ability to understand and sign the Informed Consent Form, which must be obtained before the initiation of any study procedures, and willingness to comply with the protocol requirements
- 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
Show all 10Show fewer
- 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:
- a history of oral human immunodeficiency virus pre-exposure prophylaxis with at least two prior dispensations without return for a new pickup in the six months preceding the enrollment visit, or
- a history of long-acting cabotegravir use with a delay of at least one scheduled reload dose
Who cannot join
- Known hypersensitivity to the study medication, its metabolites, or formulation excipients
- Severe hepatic impairment or a history or current clinical condition of decompensated liver cirrhosis, such as ascites, encephalopathy, or variceal bleeding
- Known or suspected severe active infection, such as active tuberculosis
- Need for continuous use of contraindicated concomitant medications
- Any clinical or psychosocial condition, or prior treatment, that in the opinion of the investigator makes the participant unsuitable for the study or unable to comply with dosing requirements
- Confirmed or suspected infection with the human immunodeficiency virus
Show all 10Show fewer
- Plans to move outside the study area during the follow-up period
- Prior participation in a clinical study using Lenacapavir in the PURPOSE study
- Prior participation in a human immunodeficiency virus vaccine study, except in cases where the participant provides documentation demonstrating receipt of placebo and not the active product
- Current participation in another interventional human immunodeficiency virus prevention study that, in the opinion of the investigator, may interfere with the conduct of this study
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Valdiléa Veloso, PhD contact
8 sites in 1 country
Brazil8 sites, 8 recruiting
- Recruiting
Centro de Referência em IST/Aids de Campinas (SMS/PMC)
Campinas, São Paulo, 13013-000
Josué Lima, 55-19-3234-5000, josue.lima@campinas.sp.gov.br
- Recruiting
CTA/Policlínica Centro
Florianópolis, Santa Catarina, 88010-400
Ronaldo Zonta, ronaldozonta@gmail.com
- Recruiting
Fundação de Medicina Tropical Heitor Vieira Dourado
Manaus, Amazonas, 69040-000
Maria Paula Mourão, 55-92-2127-3555, mariapaula.mourao@gmail.com
- Recruiting
Hospital Geral de Nova Iguaçu
Nova Iguaçu, Rio de Janeiro, 26030-380
José Henrique Pilotto, 55-21-3513-2812, jhpilotto@gmail.com
- Recruiting
Instituto Nacional de Infectologia Evandro Chagas
Rio de Janeiro, Rio de Janeiro, 21040-360
+55 2138659821, beatriz.grinsztejn@gmail.com
- Recruiting
CEDAP - Centro Especializado em Diagnóstico, Assistência e Pesquisa
Salvador, Estado de Bahia, 40100-010
Alessandro Farias, farias.alessandro@gmail.com
- Recruiting
Coordenadoria de IST/Aids da Cidade de São Paulo
São Paulo, São Paulo, 01509-020
Maria Cristina Abbate, 55-11-5461-5600, Cristinabb@prefeitura.sp.gov.br
- Recruiting
Centro de Referência e Treinamento em DST/Aids de São Paulo
São Paulo, São Paulo, 04121-000
José Valdez Madruga, 55-11-5087-9999, josevaldezmadruga@gmail.com
About this study
Official title: 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
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.
- Being tested
- Lenacapavir long-acting, Tenofovi-Emtricitabine (TDF/FTC) tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenacapavir long-actingDrug
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) tabletDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Lenacapavir | Experimental | Not described Receives: Drug: Lenacapavir long-acting |
| Tenofovir disoproxil fumarate combined with Emtricitabine | Active comparator | Not described Receives: Drug: Tenofovi-Emtricitabine (TDF/FTC) tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who remain persistent on Lenacapavir pre-exposure prophylaxis at 24 months
Persistence will be defined as the proportion of participants who initiate Lenacapavir pre-exposure prophylaxis and continue receiving scheduled Lenacapavir injections according to the recommended dosing schedule during the follow-up period. Participants will be considered non-persistent if they permanently discontinue Lenacapavir or fail to receive a scheduled injection within the allowable visit window. Persistence will be assessed using study clinic records documenting administration of Lenacapavir injections.
Measured: From enrollment to 24 months of follow-up
Time to discontinuation of Lenacapavir pre-exposure prophylaxis
Time from initiation of Lenacapavir pre-exposure prophylaxis to permanent discontinuation of Lenacapavir. Discontinuation will be defined as failure to receive a scheduled injection within the allowable visit window or documented decision to stop Lenacapavir.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start3 Feb 2026
- Primary completionFeb 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact With or Exposure to Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oswaldo Cruz Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497594
- Sponsor's protocol ID
- 88846725.0.1001.5262
- Acronym
- ImPrEP LEN
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07497594
- Acronym / sponsor ID
- ImPrEP LEN / 88846725.0.1001.5262
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Oswaldo Cruz FoundationUniversity, hospital or other
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lenacapavir | Experimental | Drug: Lenacapavir long-acting |
| Tenofovir disoproxil fumarate combined with Emtricitabine | Active comparator | Drug: Tenofovi-Emtricitabine (TDF/FTC) tablet |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Ability to understand and sign the Informed Consent Form, which must be obtained before the initiation of any study procedures, and willingness to comply with the protocol requirements
- 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
Key exclusion criteria (10 listed)
- Known hypersensitivity to the study medication, its metabolites, or formulation excipients
- Severe hepatic impairment or a history or current clinical condition of decompensated liver cirrhosis, such as ascites, encephalopathy, or variceal bleeding
- Known or suspected severe active infection, such as active tuberculosis
- Need for continuous use of contraindicated concomitant medications
- Any clinical or psychosocial condition, or prior treatment, that in the opinion of the investigator makes the participant unsuitable for the study or unable to comply with dosing requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenacapavir long-actingApproximately 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 | Drug | Lenacapavir |
| Tenofovi-Emtricitabine (TDF/FTC) tabletApproximately 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 | Drug | Tenofovir disoproxil fumarate combined with Emtricitabine |
Primary outcome
Proportion of participants who remain persistent on Lenacapavir pre-exposure prophylaxis at 24 months
Time frame: From enrollment to 24 months of follow-up
Persistence will be defined as the proportion of participants who initiate Lenacapavir pre-exposure prophylaxis and continue receiving scheduled Lenacapavir injections according to the recommended dosing schedule during the follow-up period. Participants will be considered non-persistent if they permanently discontinue Lenacapavir or fail to receive a scheduled injection within the allowable visit window. Persistence will be assessed using study clinic records documenting administration of Lenacapavir injections.
Time to discontinuation of Lenacapavir pre-exposure prophylaxis
Time frame: Up to 24 months
Time from initiation of Lenacapavir pre-exposure prophylaxis to permanent discontinuation of Lenacapavir. Discontinuation will be defined as failure to receive a scheduled injection within the allowable visit window or documented decision to stop Lenacapavir.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valdiléa Veloso, PhD contact
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lenacapavir long-acting and Tenofovi-Emtricitabine (TDF/FTC) tablet in people with Contact With or Exposure to Human Immunodeficiency Virus, run by Oswaldo Cruz Foundation at 8 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beatriz Grinsztejn, PhD (+55 2138659128, gbeatriz@ini.fiocruz.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who remain persistent on Lenacapavir pre-exposure prophylaxis at 24 months (time frame: From enrollment to 24 months of follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.