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Twice-Yearly shot could revolutionize HIV prevention

NCT ID NCT04925752

Prevention Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests lenacapavir, a long-acting drug given as a shot every six months, to prevent HIV infection. Over 3,200 participants at risk for HIV received either lenacapavir or daily pills. The goal is to see if the shot is as effective as daily PrEP, offering a more convenient option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lenacapavir (injection and tablets)
What this could lead to
If successful, this could provide a convenient twice-yearly injection to prevent HIV, reducing the need for daily pills.
What could go wrong
This is a phase 3 trial, but results are not yet published. The injection may cause side effects or be less effective than daily pills in some people.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

3,292 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: Incidence Phase * CGM, TGW, TGM, and GNB who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV infection. * HIV-1 status unknown at screening and no prior HIV-1 testing within the last 3 months. * Sexually active with ≥ 1 partner assigned male at birth (condomless receptive anal sex) in the last 12 months and 1 of the following: * Condomless receptive anal sex with ≥ 2 partners in the last 12 weeks. * History of syphilis, rectal gonorrhea, or rectal chlamydia in the last 24 weeks. * Self-reported use of stimulants with sex in the last 12 weeks. Randomized Phase * Negative local rapid fourth generation HIV-1/2 Ab/Ag, central fourth generation HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT). * Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr). Key Exclusion Criteria: Incidence Phase * Prior use of HIV PrEP (including F/TDF or F/TAF) or HIV postexposure prophylaxis (PEP) in the past 12 weeks or any prior use of long-acting systemic PrEP (including cabotegravir or islatravir). * Prior recipient of an HIV vaccine or HIV broadly neutralizing antibody formulation. Randomized Phase * Acute viral hepatitis A, B or C or evidence of chronic hepatitis B or C infection. * Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pre-exposure prophylaxis of HIV infection

Contacts and locations

Locations

  • Ararat Research Center

    San Juan, PR, 00717, Puerto Rico

  • Asociacion Civil Impacta Salud y Educacion - Sede Barranco

    Barranco, 15063, Peru

  • Asociacion Civil Impacta Salud y Educacion - Sede San Miguel

    Lima, 15088, Peru

  • Asociacion Civil Selva Amazonica

    Iquitos, Peru

  • BIOS Clinical Research

    Palm Springs, California, 92262, United States

  • Bamrasnaradura Infectious Disease Institute

    Nonthaburi, 11000, Thailand

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • Be Well Medical Center

    Berkley, Michigan, 48072, United States

  • Bridge HIV at the San Francisco Department of Public Health

    San Francisco, California, 94102, United States

  • CAN Community Health

    Miami Gardens, Florida, 33055, United States

  • CAN Community Health

    Sarasota, Florida, 34237, United States

  • CAN Community Health Clinic

    Jacksonville, Florida, 32207, United States

  • Center for Management and Research. SPDM-Paulista Association for the Development of Medicine-Hospital São Paulo/Federal

    São Paulo, 06519-332, Brazil

  • Central Texas Clinical Research

    Austin, Texas, 78705, United States

  • Centro Ararat- San Juan

    San Juan, PR, 00909, Puerto Rico

  • Centro San Vincente

    El Paso, Texas, 79915, United States

  • Centro de Investigacion Farmaceutica Especializada de Occidente S.C.

    Guadalajara C.P., 44160, Mexico

  • Centro de Referência e Treinamento DST/AIDS

    São Paulo, 04121-000, Brazil

  • Charles R. Drew University of Medicine and Science (CDU) - Clinical Translational Research Center (CTRC)

    Los Angeles, California, 90059, United States

  • Cone Health/Regional Center for Infectious Disease Research Center

    Greensboro, North Carolina, 27401, United States

  • Desmond Tutu Health Foundation

    Cape Town, 7925, South Africa

  • Emory University

    Atlanta, Georgia, 30303, United States

  • Emory University Hospital Midtown Infectious Disease Clinic

    Atlanta, Georgia, 30308, United States

  • FPD-DTHF Ndevana Commuity Research Site

    Vincent, 5217, South Africa

  • Fundacion Huesped

    Buenos Aires, 1202, Argentina

  • Fundação Bahiana de Infectologia

    Canela-Salvador, 40110-060, Brazil

  • Fundação de Medicina Tropical Doutor Heitor Vieira Dourado / Fundação Medicina Tropical do Amazonas - FMT/IMT/AM

    Manauas, 69040-000, Brazil

  • Gary Richmond, MD, PA

    Fort Lauderdale, Florida, 33316, United States

  • Grupo Hospitalar Conceição/ Hospital Nossa Senhora da Conceição S.A.

    Porto Alegre, RS 91350 200, Brazil

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hospital General de Agudos JM Ramos Mejia

    Buenos Aires, 1072, Argentina

  • Hospital General de Nova Iguaçu - HGNI

    Nova Iguaçu, 26030-380, Brazil

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo, 01246-903, Brazil

  • Howard Brown Health Center

    Chicago, Illinois, 60613, United States

  • Icahn School of Medicine at Mount Sinai- Mount Sinai Downtown

    New York, New York, 10029, United States

  • Indiana University Infectious Diseases Research

    Indianapolis, Indiana, 46202, United States

  • Institute of HIV Research and Innovation

    Bangkok, 10330, Thailand

  • Instituto Nacional de Infectologia Evandro Chagas / Fundação Oswaldo Cruz - INI FIOCRUZ

    Rio de Janeiro, 21040-360, Brazil

  • Instituto de Investigaciones Clinicas Mar del Plata

    Buenos Aires, B7600, Argentina

  • Instituto de Medicina Tropical "Daniel Alcides Carrion", Facultad de Medicina Humana, UNMSM

    Callao, 7006, Peru

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287, United States

  • KC CARE Health Center

    Kansas City, Missouri, 64111, United States

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330, Thailand

  • LSU-CrescentCare Sexual Health Center- New Orleans Community Health Center

    New Orleans, Louisiana, 70119, United States

  • Loma Linda University Clinical Trial Center Clinic

    Loma Linda, California, 92354, United States

  • Medical University of South Carolina, Infectious Disease Clinic

    Charleston, South Carolina, 29425, United States

  • Meharry Medical College Clinical and Transitional Research Center

    Nashville, Tennessee, 37208, United States

  • Methodist University Hospital/University of Tennessee Health Science Center, Clinical Research Center

    Memphis, Tennessee, 38103, United States

  • Midway Immunology & Research Center, LLC

    Ft. Pierce, Florida, 34982, United States

  • Mills Clinical Research

    Los Angeles, California, 90069, United States

  • NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • Norton Infectious Disease Specialists

    Louisville, Kentucky, 40241, United States

  • Ofiice of Dr. Peter Shalit, MD

    Seattle, Washington, 98104, United States

  • Open Arms Healthcare Center

    Jackson, Mississippi, 39202, United States

  • Optimus Medical Group

    San Francisco, California, 94102, United States

  • Orlando Immunology Center

    Orlando, Florida, 32803, United States

  • Penn Prevention Unit

    Philadelphia, Pennsylvania, 19104, United States

  • Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center

    Philadelphia, Pennsylvania, 19107, United States

  • Prisma Health Internal Medicine Clinic

    Greenville, South Carolina, 29605, United States

  • Prisma Health-Midlands Clinical Research Unit

    Columbia, South Carolina, 29203, United States

  • RMR Core Center

    Chicago, Illinois, 60612, United States

  • Ramathibodi Hospital, Mahidol University

    Bangkok, 10400, Thailand

  • Research Institute for Health Sciences, Chiang Mai University

    Chiang Mai, 50200, Thailand

  • Ruane Clinical Research Group Inc.

    Los Angeles, California, 90036, United States

  • Setshaba Research Centre

    Soshanguvhe, 0152, South Africa

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244, United States

  • Srinagarind Hospital, Khon Kaen University

    Khon Kaen, 40002, Thailand

  • St Jude Children's Research Hospital

    Memphis, Tennessee, 38105, United States

  • St. Michael's Medical Center

    Newark, New Jersey, 07102, United States

  • The Aurum Institute Tembisa CRC, Clinic 4

    Tembisa, 1632, South Africa

  • The Aurum Institute: Pretoria Clinical Research Centre

    Pretoria, 87, South Africa

  • The Crofoot Research Center, INC

    Houston, Texas, 77098, United States

  • The Fenway Institute

    Boston, Massachusetts, 02215, United States

  • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS research Centre

    Bangkok, 10330, Thailand

  • The Hope Clinic at Emory University

    Atlanta, Georgia, 30030, United States

  • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Los Angeles, California, 90502, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • Therafirst Medical Center

    Fort Lauderdale, Florida, 33308, United States

  • UAB Sexual Health Research Clinic

    Birmingham, Alabama, 35233, United States

  • UCLA CBAM Vine Street Clinic

    Los Angeles, California, 90038, United States

  • UCSD Anti Viral Research Center

    San Diego, California, 92103, United States

  • UT Health Science Center at Houston

    Houston, Texas, 77009, United States

  • Unidade de Pesquisa Clinica em Vacinas (UPqVac) da Faculdade de Medicina da Universidade

    Belo Horizonte - MG, 30130-100, Brazil

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Colorado Clinical and Translational Research Centers (CTRC)

    Aurora, Colorado, 80045, United States

  • University of Illinois at Chicago, Department of Medicine, Division of Infectious Diseases, Project WISH

    Chicago, Illinois, 60612, United States

  • University of Miami Miller School of Medicine Division of Infectious Disease Research - Converge Miami

    Miami, Florida, 33136, United States

  • Via Libre

    Lima, 15001, Peru

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27103, United States

  • Washington Health Institute

    Washington D.C., District of Columbia, 20017, United States

  • Whitman-Walker Institute Inc.

    Washington D.C., District of Columbia, 20009, United States

  • Wits Reproductive Health and HIV Institute (Wits RHI)

    Johannesburg, 2038, South Africa

  • Yale University, School of Medicine

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.