ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention

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

Overview

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.

Interventions

• Drug Lenacapavir long-acting
  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 clinic
• Drug Tenofovi-Emtricitabine (TDF/FTC) tablet
  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 scr

Primary outcome measures

• Proportion of participants who remain persistent on Lenacapavir pre-exposure prophylaxis at 24 months [Time frame: From enrollment to 24 months of follow-up]
• Time to discontinuation of Lenacapavir pre-exposure prophylaxis [Time frame: Up to 24 months]

Eligibility criteria

Inclusion criteria

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

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

Exclusion criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Brazil · 8 centers

• Fundação de Medicina Tropical Heitor Vieira Dourado — Manaus
• CEDAP - Centro Especializado em Diagnóstico, Assistência e Pesquisa — Salvador
• Hospital Geral de Nova Iguaçu — Nova Iguaçu
• Instituto Nacional de Infectologia Evandro Chagas — Rio de Janeiro
• CTA/Policlínica Centro — Florianópolis
• Centro de Referência em IST/Aids de Campinas (SMS/PMC) — Campinas
• Coordenadoria de IST/Aids da Cidade de São Paulo — São Paulo
• Centro de Referência e Treinamento em DST/Aids de São Paulo — São Paulo

Identifiers

NCT: NCT07497594 · 88846725.0.1001.5262

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗