Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People at Risk for HIV Infection (PURPOSE 2)
一项 3 期、双盲、多中心、随机研究，以评估每年两次皮下注射长效雷那卡帕韦在顺性别男性、跨性别女性、跨性别男性和 ≥ 16 岁非二元性别人群中进行 HIV 暴露前预防的疗效和安全性与男性伴侣发生性关系并有感染 HIV 风险的年龄
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.
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Cape Town、南非、7925
- Desmond Tutu Health Foundation
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Johannesburg、南非、2038
- Wits Reproductive Health and HIV Institute (Wits RHI)
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Pretoria、南非、87
- The Aurum Institute: Pretoria Clinical Research Centre
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Soshanguvhe、南非、0152
- Setshaba Research Centre
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Tembisa、南非、1632
- The Aurum Institute Tembisa CRC, Clinic 4
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Vincent、南非、5217
- FPD-DTHF Ndevana Commuity Research Site
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Guadalajara C.P.、墨西哥、44160
- Centro de Investigacion Farmaceutica Especializada de Occidente S.C.
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Belo Horizonte - MG、巴西、30130-100
- Unidade de Pesquisa Clinica em Vacinas (UPqVac) da Faculdade de Medicina da Universidade
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Canela-Salvador、巴西、40110-060
- Fundação Bahiana de Infectologia
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Manauas、巴西、69040-000
- Fundação de Medicina Tropical Doutor Heitor Vieira Dourado / Fundação Medicina Tropical do Amazonas - FMT/IMT/AM
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Nova Iguaçu、巴西、26030-380
- Hospital General de Nova Iguaçu - HGNI
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Porto Alegre、巴西、RS 91350 200
- Grupo Hospitalar Conceição/ Hospital Nossa Senhora da Conceição S.A.
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Rio de Janeiro、巴西、21040-360
- Instituto Nacional de Infectologia Evandro Chagas / Fundação Oswaldo Cruz - INI FIOCRUZ
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São Paulo、巴西、01246-903
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
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São Paulo、巴西、04121-000
- Centro de Referência e Treinamento DST/AIDS
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São Paulo、巴西、06519-332
- Center for Management and Research. SPDM-Paulista Association for the Development of Medicine-Hospital São Paulo/Federal
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PR
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San Juan、PR、波多黎各、00717
- Ararat Research Center
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San Juan、PR、波多黎各、00909
- Centro Ararat- San Juan
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Bangkok、泰国、10330
- King Chulalongkorn Memorial Hospital
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Bangkok、泰国、10400
- Ramathibodi Hospital, Mahidol University
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Bangkok、泰国、10330
- Institute of HIV Research and Innovation
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Bangkok、泰国、10330
- The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS research Centre
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Chiang Mai、泰国、50200
- Research Institute for Health Sciences, Chiang Mai University
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Khon Kaen、泰国、40002
- Srinagarind Hospital, Khon Kaen University
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Nonthaburi、泰国、11000
- Bamrasnaradura Infectious Disease Institute
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Barranco、秘鲁、15063
- Asociacion Civil Impacta Salud y Educacion - Sede Barranco
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Callao、秘鲁、7006
- Instituto de Medicina Tropical "Daniel Alcides Carrion", Facultad de Medicina Humana, UNMSM
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Iquitos、秘鲁
- Asociacion Civil Selva Amazonica
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Lima、秘鲁、15001
- Via Libre
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Lima、秘鲁、15088
- Asociacion Civil Impacta Salud y Educacion - Sede San Miguel
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Alabama
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Birmingham、Alabama、美国、35233
- UAB Sexual Health Research Clinic
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California
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Loma Linda、California、美国、92354
- Loma Linda University Clinical Trial Center Clinic
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Los Angeles、California、美国、90069
- Mills Clinical Research
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Los Angeles、California、美国、90036
- Ruane Clinical Research Group Inc.
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Los Angeles、California、美国、90038
- UCLA CBAM Vine Street Clinic
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Los Angeles、California、美国、90059
- Charles R. Drew University of Medicine and Science (CDU) - Clinical Translational Research Center (CTRC)
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Los Angeles、California、美国、90502
- The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Palm Springs、California、美国、92262
- BIOS Clinical Research
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San Diego、California、美国、92103
- UCSD Anti Viral Research Center
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San Francisco、California、美国、94102
- Optimus Medical Group
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San Francisco、California、美国、94102
- Bridge HIV at the San Francisco Department of Public Health
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Colorado
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Aurora、Colorado、美国、80045
- University of Colorado Clinical and Translational Research Centers (CTRC)
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Connecticut
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New Haven、Connecticut、美国、06510
- Yale University, School of Medicine
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District of Columbia
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Washington D.C.、District of Columbia、美国、20009
- Whitman-Walker Institute Inc.
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Washington D.C.、District of Columbia、美国、20017
- Washington Health Institute
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Florida
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Fort Lauderdale、Florida、美国、33308
- Therafirst Medical Center
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Fort Lauderdale、Florida、美国、33316
- Gary Richmond, MD, PA
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Ft. Pierce、Florida、美国、34982
- Midway Immunology & Research Center, LLC
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Jacksonville、Florida、美国、32207
- CAN Community Health Clinic
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Miami、Florida、美国、33136
- University of Miami Miller School of Medicine Division of Infectious Disease Research - Converge Miami
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Miami Gardens、Florida、美国、33055
- CAN Community Health
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Orlando、Florida、美国、32803
- Orlando Immunology Center
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Sarasota、Florida、美国、34237
- CAN Community Health
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Georgia
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Atlanta、Georgia、美国、30303
- Emory University
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Atlanta、Georgia、美国、30308
- Emory University Hospital Midtown Infectious Disease Clinic
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Atlanta、Georgia、美国、30030
- The Hope Clinic at Emory University
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Illinois
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Chicago、Illinois、美国、60613
- Howard Brown Health Center
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Chicago、Illinois、美国、60612
- RMR Core Center
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Chicago、Illinois、美国、60612
- University of Illinois at Chicago, Department of Medicine, Division of Infectious Diseases, Project WISH
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Indiana
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Indianapolis、Indiana、美国、46202
- Indiana University Infectious Diseases Research
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Kentucky
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Lexington、Kentucky、美国、40503
- Baptist Health Lexington
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Louisville、Kentucky、美国、40241
- Norton Infectious Disease Specialists
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Louisiana
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New Orleans、Louisiana、美国、70119
- LSU-CrescentCare Sexual Health Center- New Orleans Community Health Center
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Maryland
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Baltimore、Maryland、美国、21287
- Johns Hopkins University School of Medicine
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Massachusetts
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Boston、Massachusetts、美国、02215
- The Fenway Institute
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Michigan
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Berkley、Michigan、美国、48072
- Be Well Medical Center
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Detroit、Michigan、美国、48202
- Henry Ford Hospital
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Mississippi
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Jackson、Mississippi、美国、39202
- Open Arms Healthcare Center
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Missouri
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Kansas City、Missouri、美国、64111
- KC CARE Health Center
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New Jersey
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Newark、New Jersey、美国、07102
- St. Michael's Medical Center
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Somers Point、New Jersey、美国、08244
- South Jersey Infectious Disease
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New York
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New York、New York、美国、10029
- Icahn School of Medicine at Mount Sinai- Mount Sinai Downtown
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North Carolina
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Chapel Hill、North Carolina、美国、27514
- NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill
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Greensboro、North Carolina、美国、27401
- Cone Health/Regional Center for Infectious Disease Research Center
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Winston-Salem、North Carolina、美国、27103
- Wake Forest University Health Sciences
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Ohio
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Cincinnati、Ohio、美国、45267
- University of Cincinnati
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Columbus、Ohio、美国、43210
- The Ohio State University Wexner Medical Center
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Penn Prevention Unit
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Philadelphia、Pennsylvania、美国、19107
- Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center
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South Carolina
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Charleston、South Carolina、美国、29425
- Medical University of South Carolina, Infectious Disease Clinic
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Columbia、South Carolina、美国、29203
- Prisma Health-Midlands Clinical Research Unit
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Greenville、South Carolina、美国、29605
- Prisma Health Internal Medicine Clinic
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Tennessee
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Memphis、Tennessee、美国、38105
- St Jude Children's Research Hospital
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Memphis、Tennessee、美国、38103
- Methodist University Hospital/University of Tennessee Health Science Center, Clinical Research Center
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Nashville、Tennessee、美国、37208
- Meharry Medical College Clinical and Transitional Research Center
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Texas
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Austin、Texas、美国、78705
- Central Texas Clinical Research
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El Paso、Texas、美国、79915
- Centro San Vincente
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Houston、Texas、美国、77098
- The Crofoot Research Center, INC
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Houston、Texas、美国、77009
- UT Health Science Center at Houston
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Washington
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Seattle、Washington、美国、98104
- Ofiice of Dr. Peter Shalit, MD
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Buenos Aires、阿根廷、1072
- Hospital General de Agudos JM Ramos Mejia
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Buenos Aires、阿根廷、B7600
- Instituto de Investigaciones Clinicas Mar del Plata
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Buenos Aires、阿根廷、1202
- Fundacion Huesped
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Key Inclusion Criteria:
Incidence Phase
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CGM, TGW, TGM, and GNB who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV infection.
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HIV-1 status unknown at screening and no prior HIV-1 testing within the last 3 months.
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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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Randomized Blinded Phase: LEN + Placebo-to-match (PTM) F/TDF
Participants will receive the following for up to approximately 52 weeks:
Participants will receive oral LEN if SC injections are not available. |
Tablets administered orally without regard to food
其他名称：
Administered via SC injections
其他名称：
Tablets administered orally |
|
实验性的：Randomized Blinded Phase: Placebo LEN + F/TDF
Participants will receive the following for up to approximately 52 weeks:
Participants will receive oral LEN placebo if SC injections are not available. |
Tablets administered orally
其他名称：
Administered via SC injections Tablets administered orally |
|
实验性的：LEN Open-Label Extension (OLE) Phase
Participants 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. |
Tablets administered orally without regard to food
其他名称：
Administered via SC injections
其他名称：
|
|
实验性的：Pharmacokinetic (PK) Tail Phase
Participants 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. |
Tablets administered orally
其他名称：
F/TAF tablets administered orally once daily
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence Phase: Recent Infection Testing Algorithm (RITA) Estimate of the Background Human Immunodeficiency-1 Virus Infection Incidence Rate (bHIV) Per 100 Person Years (PY)
大体时间：Incidence Phase Screening Visit (Day 1)
|
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:
|
Incidence Phase Screening Visit (Day 1)
|
|
Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN Compared to Background HIV (bHIV, Participants in All Screened Set)
大体时间：Up to 149 weeks
|
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. |
Up to 149 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN Compared to F/TDF
大体时间：Up to 149 weeks
|
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. |
Up to 149 weeks
|
|
Randomized Blinded Phase: HIV-1 Incidence Among Participants Adherent to LEN
大体时间：Up to 149 weeks
|
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. |
Up to 149 weeks
|
|
Randomized Blinded Phase: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
大体时间：First dose date up to 184 weeks
|
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. |
First dose date up to 184 weeks
|
|
Randomized Blinded Phase: Percentage of Participants Experiencing Grade 3 or Higher Laboratory Abnormalities
大体时间：First dose date up to 184 weeks
|
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. |
First dose date up to 184 weeks
|
合作者和调查者
调查人员
- 研究主任：Gilead Study Director、Gilead Sciences
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- GS-US-528-9023
- DOH-27-102021-6681 (其他标识符：South African National Clinical Trial Registry)
- 2023 (美国 NIH 拨款/合同)
- 2023-001025-23 (EudraCT编号)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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