AzTrials
AzTrials

Pre-Exposure Prophylaxis of HIV InfectionPhase 3PURPOSE 2NCT04925752

Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People at Risk for HIV Infection

A Phase 3 study testing Oral Lenacapavir (LEN), F/TDF and Sub-cutaneous (SC) Lenacapavir (LEN) in people with Pre-Exposure Prophylaxis of HIV Infection, run by Gilead Sciences at 93 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) in preventing HIV infection, in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV-1 infection. Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
What is being tested?
Oral Lenacapavir (LEN), F/TDF and Sub-cutaneous (SC) Lenacapavir (LEN)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,292 participants
Where
93 sitesin 8 countries
Study dates
28 Jun 2021to Aug 2028
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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).

Who cannot join

  • 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.

Trial locations and contacts

93 sites in 8 countries.

93 sites in 8 countries

United States60 sites

  • The Hope Clinic at Emory University

    Atlanta, Georgia, 30030

  • Emory University

    Atlanta, Georgia, 30303

  • Emory University Hospital Midtown Infectious Disease Clinic

    Atlanta, Georgia, 30308

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

    Aurora, Colorado, 80045

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • UAB Sexual Health Research Clinic

    Birmingham, Alabama, 35233

  • The Fenway Institute

    Boston, Massachusetts, 02215

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

    Chapel Hill, North Carolina, 27514

  • Medical University of South Carolina, Infectious Disease Clinic

    Charleston, South Carolina, 29425

  • RMR Core Center

    Chicago, Illinois, 60612

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

    Chicago, Illinois, 60612

  • Howard Brown Health Center

    Chicago, Illinois, 60613

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Prisma Health-Midlands Clinical Research Unit

    Columbia, South Carolina, 29203

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Centro San Vincente

    El Paso, Texas, 79915

  • Therafirst Medical Center

    Fort Lauderdale, Florida, 33308

  • Gary Richmond, MD, PA

    Fort Lauderdale, Florida, 33316

  • Midway Immunology & Research Center, LLC

    Ft. Pierce, Florida, 34982

  • Cone Health/Regional Center for Infectious Disease Research Center

    Greensboro, North Carolina, 27401

  • Prisma Health Internal Medicine Clinic

    Greenville, South Carolina, 29605

  • UT Health Science Center at Houston

    Houston, Texas, 77009

  • The Crofoot Research Center, INC

    Houston, Texas, 77098

  • Indiana University Infectious Diseases Research

    Indianapolis, Indiana, 46202

  • Open Arms Healthcare Center

    Jackson, Mississippi, 39202

  • CAN Community Health Clinic

    Jacksonville, Florida, 32207

  • KC CARE Health Center

    Kansas City, Missouri, 64111

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Loma Linda University Clinical Trial Center Clinic

    Loma Linda, California, 92354

  • Ruane Clinical Research Group Inc.

    Los Angeles, California, 90036

  • UCLA CBAM Vine Street Clinic

    Los Angeles, California, 90038

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

    Los Angeles, California, 90059

  • Mills Clinical Research

    Los Angeles, California, 90069

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

    Los Angeles, California, 90502

  • Norton Infectious Disease Specialists

    Louisville, Kentucky, 40241

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

    Memphis, Tennessee, 38103

  • St Jude Children's Research Hospital

    Memphis, Tennessee, 38105

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

    Miami, Florida, 33136

  • CAN Community Health

    Miami Gardens, Florida, 33055

  • Meharry Medical College Clinical and Transitional Research Center

    Nashville, Tennessee, 37208

  • Yale University, School of Medicine

    New Haven, Connecticut, 06510

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

    New Orleans, Louisiana, 70119

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

    New York, New York, 10029

  • St. Michael's Medical Center

    Newark, New Jersey, 07102

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • BIOS Clinical Research

    Palm Springs, California, 92262

  • Penn Prevention Unit

    Philadelphia, Pennsylvania, 19104

  • Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center

    Philadelphia, Pennsylvania, 19107

  • UCSD Anti Viral Research Center

    San Diego, California, 92103

  • Bridge HIV at the San Francisco Department of Public Health

    San Francisco, California, 94102

  • Optimus Medical Group

    San Francisco, California, 94102

  • CAN Community Health

    Sarasota, Florida, 34237

  • Ofiice of Dr. Peter Shalit, MD

    Seattle, Washington, 98104

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244

  • Whitman-Walker Institute Inc.

    Washington D.C., District of Columbia, 20009

  • Washington Health Institute

    Washington D.C., District of Columbia, 20017

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27103

Other trials in United States

Brazil9 sites

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

    Belo Horizonte - MG, 30130-100

  • Fundação Bahiana de Infectologia

    Canela-Salvador, 40110-060

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

    Manauas, 69040-000

  • Hospital General de Nova Iguaçu - HGNI

    Nova Iguaçu, 26030-380

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

    Porto Alegre, RS 91350 200

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

    Rio de Janeiro, 21040-360

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

    São Paulo, 01246-903

  • Centro de Referência e Treinamento DST/AIDS

    São Paulo, 04121-000

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

    São Paulo, 06519-332

Other trials in Brazil

Thailand7 sites

  • Institute of HIV Research and Innovation

    Bangkok, 10330

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330

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

    Bangkok, 10330

  • Ramathibodi Hospital, Mahidol University

    Bangkok, 10400

  • Research Institute for Health Sciences, Chiang Mai University

    Chiang Mai, 50200

  • Srinagarind Hospital, Khon Kaen University

    Khon Kaen, 40002

  • Bamrasnaradura Infectious Disease Institute

    Nonthaburi, 11000

Other trials in Thailand

South Africa6 sites

  • Desmond Tutu Health Foundation

    Cape Town, 7925

  • Wits Reproductive Health and HIV Institute (Wits RHI)

    Johannesburg, 2038

  • The Aurum Institute: Pretoria Clinical Research Centre

    Pretoria, 87

  • Setshaba Research Centre

    Soshanguvhe, 0152

  • The Aurum Institute Tembisa CRC, Clinic 4

    Tembisa, 1632

  • FPD-DTHF Ndevana Commuity Research Site

    Vincent, 5217

Other trials in South Africa

Peru5 sites

  • Asociacion Civil Impacta Salud y Educacion - Sede Barranco

    Barranco, 15063

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

    Callao, 7006

  • Asociacion Civil Selva Amazonica

    Iquitos

  • Via Libre

    Lima, 15001

  • Asociacion Civil Impacta Salud y Educacion - Sede San Miguel

    Lima, 15088

Other trials in Peru

Argentina3 sites

  • Hospital General de Agudos JM Ramos Mejia

    Buenos Aires, 1072

  • Fundacion Huesped

    Buenos Aires, 1202

  • Instituto de Investigaciones Clinicas Mar del Plata

    Buenos Aires, B7600

Other trials in Argentina

Puerto Rico2 sites

  • Ararat Research Center

    San Juan, PR, 00717

  • Centro Ararat- San Juan

    San Juan, PR, 00909

Other trials in Puerto Rico

Mexico1 site

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

    Guadalajara C.P., 44160

Other trials in Mexico

About this study

Official title: A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People ≥ 16 Years of Age Who Have Sex With Male Partners and Are at Risk for HIV Infection

The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) in preventing HIV infection, in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV-1 infection.

The primary objective of this study is to evaluate the efficacy of LEN for HIV-1 pre-exposure prophylaxis (PrEP) in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth at risk of HIV-1 infection.

Being tested
Oral Lenacapavir (LEN), F/TDF, Sub-cutaneous (SC) Lenacapavir (LEN), Placebo SC LEN, PTM F/TDF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral Lenacapavir (LEN)Drug

    Also called GS-6207

    Tablets administered orally without regard to food

  • F/TDFDrug

    Also called Truvada®

    Tablets administered orally

  • Sub-cutaneous (SC) Lenacapavir (LEN)Drug

    Also called GS-6207; Yeztugo

    Administered via SC injections

  • Placebo SC LENDrug

    Administered via SC injections

  • PTM F/TDFDrug

    Tablets administered orally

  • PTM Oral LENDrug

    Tablets administered orally

  • F/TAF (for US participants only)Drug

    Also called Descovy

    F/TAF tablets administered orally once daily

Study groups in NCT04925752
Study groupRoleWhat they receive
Randomized Blinded Phase: LEN + Placebo-to-match (PTM) F/TDFExperimentalParticipants will receive the following for up to approximately 52 weeks: * Subcutaneous (SC) lenacapavir (LEN) 927 mg every 26 weeks * Oral PTM Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) once daily * Oral LEN 600 mg on Days 1 and 2 Participants will receive oral LEN if SC injections are not available.
Receives: Drug: Oral Lenacapavir (LEN); Drug: Sub-cutaneous (SC) Lenacapavir (LEN); Drug: PTM F/TDF
Randomized Blinded Phase: Placebo LEN + F/TDFExperimentalParticipants will receive the following for up to approximately 52 weeks: * SC LEN placebo every 26 weeks * Oral F/TDF 200/300 mg once daily * PTM Oral LEN on Days 1 and 2 Participants will receive oral LEN placebo if SC injections are not available.
Receives: Drug: F/TDF; Drug: Placebo SC LEN; Drug: PTM Oral LEN
LEN Open-Label Extension (OLE) PhaseExperimentalParticipants will be offered entry into LEN OLE Phase, following completion of primary analysis, if LEN demonstrates acceptable safety and efficacy in the Randomized Blinded Phase. Participants randomized to LEN will continue to receive SC LEN 927 mg, every 26 weeks (± 7 days), and have study visits every 13 weeks (± 7 days). Participants randomized to F/TDF will switch to SC LEN 927 mg on OLE Day 1, Week 26 and every 26 weeks thereafter. Participants will also receive oral LEN 600 mg on OLE Days 1 and 2. All participants in LEN OLE Phase will complete the phase, once LEN becomes available or the sponsor decides to discontinue the study, whichever happens first. After completing LEN OLE Phase or study discontinuation, participants will transition to local PrEP, including LEN or other options. If a participant exits early, they will complete an early study drug discontinuation (ESDD), be referred to local PrEP services if needed, and have a 30-day follow-up visit.
Receives: Drug: Oral Lenacapavir (LEN); Drug: Sub-cutaneous (SC) Lenacapavir (LEN)
Pharmacokinetic (PK) Tail PhaseExperimentalParticipants who prematurely discontinue study drug during the Randomized Blinded Phase and participants that were randomized to LEN who choose not to continue in the LEN OLE Phase will transition to the PK Tail Phase. Participants will receive oral F/TDF (or Emtricitabine/Tenofovir Alafenamide (F/TAF) for US participants only) once daily for 78 weeks to cover the PK tail and complete visits every 13 weeks (+/- 7 days). Upon unblinding, participants who were randomized to F/TDF in the Randomized Blinded Phase who decline to participate in the LEN OLE Phase will complete the ESDD visit, transition to local HIV prevention services, and return for a 30-day follow-up visit.
Receives: Drug: F/TDF; Drug: F/TAF (for US participants only)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence Phase: Recent Infection Testing Algorithm (RITA) Estimate of the Background Human Immunodeficiency-1 Virus Infection Incidence Rate (bHIV) Per 100 Person Years (PY)

    bHIV per 100 PY in the Incidence Phase was calculated using RITA. The RITA incorporated HIV-1 testing results and recency assay testing results to estimate the bHIV. Recency assay testing was performed for participants in the All Screened Set found to have HIV-1 infection at the Incidence Phase Screening Visit as defined below. Participants were considered to have recent HIV-1 infection if the normalized optical density (ODn) was below 1.5 threshold using the Sedia limiting antigen avidity enzyme immunoassay (LAg-EIA) and the HIV-1 RNA (viral load) was > 75 copies/mL of blood.

    HIV-1 infection was defined as participants having at least one of the following central lab results at the Incidence Phase screening visit:

    • Positive HIV-1/2 differentiation Ab, OR
    • Positive HIV-1 ribonucleic acid (RNA) qualitative test, OR
    • HIV-1 RNA quantitative test ≥200 copies/mL.

    Measured: Incidence Phase Screening Visit (Day 1)

  2. Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN Compared to Background HIV (bHIV, Participants in All Screened Set)

    HIV-1 incidence per 100 PY for LEN was calculated as the number of participants who acquired HIV-1 divided by the total of a) for participants not diagnosed with HIV-1, sum of all duration of follow-up time in years, while at risk of HIV-1 infection (where a year is 365.25 days) and b) for participants diagnosed with HIV-1, sum of all duration of follow-up time up to confirmed HIV-1 diagnoses. HIV-1 diagnosis was determined by an HIV adjudication committee who reviewed potential HIV-1 infection events in the randomized participants. The committee, in a blinded, consistent, and unbiased manner, determined whether HIV test results confirmed HIV-1 infection and determined the date of diagnosis for each case, defined as the date of the earliest study visit with evidence of HIV infection considering both prospective HIV testing and back-testing of archived samples. bHIV incidence per 100 PY in All Screened Set was estimated as described in outcome measure#1.

    Measured: Up to 149 weeks

Secondary outcomes (4)

  1. Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN Compared to F/TDF

    HIV-1 incidence per 100 PY was calculated as the number of participants who acquired HIV-1 divided by the total of a) for participants not diagnosed with HIV-1, sum of all duration of follow-up time in years, while at risk of HIV-1 infection (where a year is 365.25 days) and b) for participants diagnosed with HIV-1, sum of all duration of follow-up time up to confirmed HIV-1 diagnoses. HIV-1 diagnosis was determined by an HIV adjudication committee who reviewed potential HIV-1 infection events in the randomized participants. The committee, in a blinded, consistent, and unbiased manner, determined whether HIV test results confirmed HIV-1 infection and determined the date of diagnosis for each case, defined as the date of the earliest study visit with evidence of HIV infection considering both prospective HIV testing and back-testing of archived samples.

    Measured: Up to 149 weeks

  2. Randomized Blinded Phase: HIV-1 Incidence Among Participants Adherent to LEN

    A participant was defined as adherent to LEN if they have received all per-protocol administrations of LEN within 28 weeks since the previous administration. The incidence of HIV-1 infection per 100 PY calculation is defined in outcome measure #2.

    Measured: Up to 149 weeks

  3. Randomized Blinded Phase: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

    An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a study drug that did not necessarily have a causal relationship with the treatment. TEAEs were defined as 1 or both of the following: Any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug.

    Measured: First dose date up to 184 weeks

  4. Randomized Blinded Phase: Percentage of Participants Experiencing Grade 3 or Higher Laboratory Abnormalities

    Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any post-baseline visit, up to and including the last exposure date for participants who permanently discontinued study drug, or the last available date in the database snapshot for participants who were still on treatment at the time of an analysis. The division of acquired immunodeficiency syndrome toxicity grading scale, Version 2.1 was used to assign toxicity grades (0 to 4) to laboratory results for analysis. Grade 0 included all values that do not meet the criteria for an abnormality of at least Grade 1. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 potentially life-threatening. Percentages were rounded off.

    Measured: First dose date up to 184 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2021
  2. Study start28 Jun 2021
  3. Primary completion21 Aug 2024
  4. Study completionAug 2028 (estimated)

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
3,292 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04925752
Sponsor's protocol ID
GS-US-528-9023
Other IDs
DOH-27-102021-6681, 2023-001025-23, 2023
Acronym
PURPOSE 2
Status last verified
Sep 2026
First submitted
28 May 2021
Last updated
6 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kelley CF, Acevedo-Quiñones M, Agwu AL, et al. Twice-yearly lenacapavir PrEP in cisgender gay men, transgender women and men, and gender-diverse people (PURPOSE 2). Presented at: HIV Drug Therapy Glasgow; November 10-13, 2024; Glasgow, United Kingdom.

  • Kelley CF, Acevedo-Quinones M, Agwu AL, Avihingsanon A, Benson P, Blumenthal J, Brinson C, Brites C, Cahn P, Cantos VD, Clark J, Clement M, Creticos C, Crofoot G, Diaz RS, Doblecki-Lewis S, Gallardo-Cartagena JA, Gaur A, Grinsztejn B, Hassler S, Hinojosa JC, Hodge T, Kaplan R, Lacerda M, LaMarca A, Losso MH, Valdez Madruga J, Mayer KH, Mills A, Mounzer K, Ndlovu N, Novak RM, Perez Rios A, Phanuphak N, Ramgopal M, Ruane PJ, Sanchez J, Santos B, Schine P, Schreibman T, Spencer LY, Van Gerwen OT, Vasconcelos R, Vasquez JG, Zwane Z, Cox S, Deaton C, Ebrahimi R, Wong P, Singh R, Brown LB, Carter CC, Das M, Baeten JM, Ogbuagu O; PURPOSE 2 Study Team. Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons. N Engl J Med. 2025 Apr 3;392(13):1261-1276. doi: 10.1056/NEJMoa2411858. Epub 2024 Nov 27.

    PubMed 39602624

  • Cespedes M, Das M, Hojilla JC, Blumenthal J, Mounzer K, Ramgopal M, Hodge T, Torres TS, Peterson C, Shibase S, Elliott A, Demidont AC, Callaghan L, Watson CC, Carter C, Kintu A, Baeten JM, Ogbuagu O. Proactive strategies to optimize engagement of Black, Hispanic/Latinx, transgender, and nonbinary individuals in a trial of a novel agent for HIV pre-exposure prophylaxis (PrEP). PLoS One. 2022 Jun 3;17(6):e0267780. doi: 10.1371/journal.pone.0267780. eCollection 2022.

    PubMed 35657826

  • Cantos Lucio VD, Mngadi K, Supparatpinyo K, et al. From Breakthroughs to Backbones: The Evolving Landscape of HIV PrEP. Presented at: Conference on Retroviruses and Opportunistic Infections (CROI 2026); February 22-25, 2026; Denver, CO. Abstract 129.

  • Kwan TH, Chan DPC, Lee SS. Utilisation of HIV pre-exposure prophylaxis and preferences of alternative long-acting modalities among men who have sex with men in Hong kong: a cross-sectional study. BMC Public Health. 2025 Dec 26;26(1):361. doi: 10.1186/s12889-025-26025-5.

    PubMed 41449429

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oral Lenacapavir (LEN), F/TDF and Sub-cutaneous (SC) Lenacapavir (LEN) in people with Pre-Exposure Prophylaxis of HIV Infection, run by Gilead Sciences at 93 sites in 8 countries.

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 7 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States, Brazil, Thailand, South Africa, Peru and 3 more countries. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence Phase: Recent Infection Testing Algorithm (RITA) Estimate of the Background Human Immunodeficiency-1 Virus Infection Incidence Rate (bHIV) Per 100 Person Years (PY) (time frame: Incidence Phase Screening Visit (Day 1)). 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?

On the ClinicalTrials.gov record for NCT04925752, which also lists 5 linked publications.

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 6 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in