Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People at Risk for HIV Infection (PURPOSE 2)
시스젠더 남성, 트랜스젠더 여성, 트랜스젠더 남성 및 성별 논바이너리(16년 이상 남성 파트너와 성관계를 갖고 HIV 감염 위험이 있는 연령
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.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Cape Town, 남아프리카, 7925
- Desmond Tutu Health Foundation
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Johannesburg, 남아프리카, 2038
- Wits Reproductive Health and HIV Institute (Wits RHI)
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Pretoria, 남아프리카, 87
- The Aurum Institute: Pretoria Clinical Research Centre
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Soshanguvhe, 남아프리카, 0152
- Setshaba Research Centre
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Tembisa, 남아프리카, 1632
- The Aurum Institute Tembisa CRC, Clinic 4
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Vincent, 남아프리카, 5217
- FPD-DTHF Ndevana Commuity Research Site
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Guadalajara C.P., 멕시코, 44160
- Centro de Investigacion Farmaceutica Especializada de Occidente S.C.
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Alabama
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Birmingham, Alabama, 미국, 35233
- UAB Sexual Health Research Clinic
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California
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Loma Linda, California, 미국, 92354
- Loma Linda University Clinical Trial Center Clinic
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Los Angeles, California, 미국, 90069
- Mills Clinical Research
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Los Angeles, California, 미국, 90036
- Ruane Clinical Research Group Inc.
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Los Angeles, California, 미국, 90038
- UCLA CBAM Vine Street Clinic
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Los Angeles, California, 미국, 90059
- Charles R. Drew University of Medicine and Science (CDU) - Clinical Translational Research Center (CTRC)
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Los Angeles, California, 미국, 90502
- The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Palm Springs, California, 미국, 92262
- BIOS Clinical Research
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San Diego, California, 미국, 92103
- UCSD Anti Viral Research Center
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San Francisco, California, 미국, 94102
- Optimus Medical Group
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San Francisco, California, 미국, 94102
- Bridge HIV at the San Francisco Department of Public Health
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Colorado
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Aurora, Colorado, 미국, 80045
- University of Colorado Clinical and Translational Research Centers (CTRC)
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Connecticut
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New Haven, Connecticut, 미국, 06510
- Yale University, School of Medicine
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20009
- Whitman-Walker Institute Inc.
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Washington D.C., District of Columbia, 미국, 20017
- Washington Health Institute
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Florida
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Fort Lauderdale, Florida, 미국, 33308
- Therafirst Medical Center
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Fort Lauderdale, Florida, 미국, 33316
- Gary Richmond, MD, PA
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Ft. Pierce, Florida, 미국, 34982
- Midway Immunology & Research Center, LLC
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Jacksonville, Florida, 미국, 32207
- CAN Community Health Clinic
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Miami, Florida, 미국, 33136
- University of Miami Miller School of Medicine Division of Infectious Disease Research - Converge Miami
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Miami Gardens, Florida, 미국, 33055
- CAN Community Health
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Orlando, Florida, 미국, 32803
- Orlando Immunology Center
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Sarasota, Florida, 미국, 34237
- CAN Community Health
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Georgia
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Atlanta, Georgia, 미국, 30303
- Emory University
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Atlanta, Georgia, 미국, 30308
- Emory University Hospital Midtown Infectious Disease Clinic
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Atlanta, Georgia, 미국, 30030
- The Hope Clinic at Emory University
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Illinois
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Chicago, Illinois, 미국, 60613
- Howard Brown Health Center
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Chicago, Illinois, 미국, 60612
- RMR Core Center
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Chicago, Illinois, 미국, 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, 미국, 46202
- Indiana University Infectious Diseases Research
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Kentucky
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Lexington, Kentucky, 미국, 40503
- Baptist Health Lexington
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Louisville, Kentucky, 미국, 40241
- Norton Infectious Disease Specialists
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Louisiana
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New Orleans, Louisiana, 미국, 70119
- LSU-CrescentCare Sexual Health Center- New Orleans Community Health Center
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Maryland
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Baltimore, Maryland, 미국, 21287
- Johns Hopkins University School of Medicine
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- The Fenway Institute
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Michigan
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Berkley, Michigan, 미국, 48072
- Be Well Medical Center
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Detroit, Michigan, 미국, 48202
- Henry Ford Hospital
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Mississippi
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Jackson, Mississippi, 미국, 39202
- Open Arms Healthcare Center
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Missouri
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Kansas City, Missouri, 미국, 64111
- KC CARE Health Center
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New Jersey
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Newark, New Jersey, 미국, 07102
- St. Michael's Medical Center
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Somers Point, New Jersey, 미국, 08244
- South Jersey Infectious Disease
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New York
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New York, New York, 미국, 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, 미국, 27514
- NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill
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Greensboro, North Carolina, 미국, 27401
- Cone Health/Regional Center for Infectious Disease Research Center
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Winston-Salem, North Carolina, 미국, 27103
- Wake Forest University Health Sciences
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Ohio
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Cincinnati, Ohio, 미국, 45267
- University of Cincinnati
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Columbus, Ohio, 미국, 43210
- The Ohio State University Wexner Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- Penn Prevention Unit
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Philadelphia, Pennsylvania, 미국, 19107
- Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center
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South Carolina
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Charleston, South Carolina, 미국, 29425
- Medical University of South Carolina, Infectious Disease Clinic
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Columbia, South Carolina, 미국, 29203
- Prisma Health-Midlands Clinical Research Unit
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Greenville, South Carolina, 미국, 29605
- Prisma Health Internal Medicine Clinic
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Tennessee
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Memphis, Tennessee, 미국, 38105
- St Jude Children's Research Hospital
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Memphis, Tennessee, 미국, 38103
- Methodist University Hospital/University of Tennessee Health Science Center, Clinical Research Center
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Nashville, Tennessee, 미국, 37208
- Meharry Medical College Clinical and Transitional Research Center
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Texas
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Austin, Texas, 미국, 78705
- Central Texas Clinical Research
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El Paso, Texas, 미국, 79915
- Centro San Vincente
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Houston, Texas, 미국, 77098
- The Crofoot Research Center, INC
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Houston, Texas, 미국, 77009
- UT Health Science Center at Houston
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Washington
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Seattle, Washington, 미국, 98104
- Ofiice of Dr. Peter Shalit, MD
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Belo Horizonte - MG, 브라질, 30130-100
- Unidade de Pesquisa Clinica em Vacinas (UPqVac) da Faculdade de Medicina da Universidade
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Canela-Salvador, 브라질, 40110-060
- Fundação Bahiana de Infectologia
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Manauas, 브라질, 69040-000
- Fundação de Medicina Tropical Doutor Heitor Vieira Dourado / Fundação Medicina Tropical do Amazonas - FMT/IMT/AM
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Nova Iguaçu, 브라질, 26030-380
- Hospital General de Nova Iguaçu - HGNI
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Porto Alegre, 브라질, RS 91350 200
- Grupo Hospitalar Conceição/ Hospital Nossa Senhora da Conceição S.A.
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Rio de Janeiro, 브라질, 21040-360
- Instituto Nacional de Infectologia Evandro Chagas / Fundação Oswaldo Cruz - INI FIOCRUZ
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São Paulo, 브라질, 01246-903
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
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São Paulo, 브라질, 04121-000
- Centro de Referência e Treinamento DST/AIDS
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São Paulo, 브라질, 06519-332
- Center for Management and Research. SPDM-Paulista Association for the Development of Medicine-Hospital São Paulo/Federal
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Buenos Aires, 아르헨티나, 1072
- Hospital General de Agudos JM Ramos Mejia
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Buenos Aires, 아르헨티나, B7600
- Instituto de Investigaciones Clinicas Mar del Plata
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Buenos Aires, 아르헨티나, 1202
- Fundacion Huesped
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Bangkok, 태국, 10330
- King Chulalongkorn Memorial Hospital
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Bangkok, 태국, 10400
- Ramathibodi Hospital, Mahidol University
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Bangkok, 태국, 10330
- Institute of HIV Research and Innovation
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Bangkok, 태국, 10330
- The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS research Centre
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Chiang Mai, 태국, 50200
- Research Institute for Health Sciences, Chiang Mai University
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Khon Kaen, 태국, 40002
- Srinagarind Hospital, Khon Kaen University
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Nonthaburi, 태국, 11000
- Bamrasnaradura Infectious Disease Institute
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Barranco, 페루, 15063
- Asociacion Civil Impacta Salud y Educacion - Sede Barranco
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Callao, 페루, 7006
- Instituto de Medicina Tropical "Daniel Alcides Carrion", Facultad de Medicina Humana, UNMSM
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Iquitos, 페루
- Asociacion Civil Selva Amazonica
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Lima, 페루, 15001
- Via Libre
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Lima, 페루, 15088
- Asociacion Civil Impacta Salud y Educacion - Sede San Miguel
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PR
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San Juan, PR, 푸에르토 리코, 00717
- Ararat Research Center
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San Juan, PR, 푸에르토 리코, 00909
- Centro Ararat- San Juan
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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
다른 이름들:
Administered via SC injections
다른 이름들:
Tablets administered orally |
|
실험적: 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
다른 이름들:
Administered via SC injections Tablets administered orally |
|
실험적: 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
다른 이름들:
Administered via SC injections
다른 이름들:
|
|
실험적: 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
다른 이름들:
F/TAF tablets administered orally once daily
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence Phase: Recent Infection Testing Algorithm (RITA) Estimate of the Background Human Immunodeficiency-1 Virus Infection Incidence Rate (bHIV) Per 100 Person Years (PY)
기간: 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)
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN Compared to F/TDF
기간: 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
기간: 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)
기간: 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
기간: 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
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Gilead Study Director, Gilead Sciences
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- GS-US-528-9023
- DOH-27-102021-6681 (기타 식별자: South African National Clinical Trial Registry)
- 2023 (미국 NIH 보조금/계약)
- 2023-001025-23 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .