Clinical trial NCT04925752: Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Pre-Exposure Prophylaxis of HIV Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2021-06-14
Enrollment: 3295
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical study is to test how well the study drug, lenacapavir (LEN), works in preventing the risk of HIV.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence Phase: Background HIV Incidence per 100-Person-Years (PY)
timeFrame: At Screening
measure: Randomized Phase: Number of Participants with Diagnosis of HIV-1 Infection
timeFrame: When all participants have completed a minimum of 52 weeks of follow-up in the study, or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks)
Secondary outcomes:
measure: Number of Participants with Diagnosis of HIV Among Participants While Adherent to Study Drug
timeFrame: When all participants have completed a minimum of 52 weeks of follow-up in the study, or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks)
measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events
timeFrame: When all participants have completed a minimum of 52 weeks of follow-up in the study, or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks)
measure: Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
timeFrame: When all participants have completed a minimum of 52 weeks of follow-up in the study, or permanent discontinuation, whichever occurs first (maximum approximately 130 weeks)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Sexual Health Research Clinic
state: Alabama
city: Loma Linda
country: United States
facility: Loma Linda University Clinical Trial Center Clinic
state: California
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group Inc.
state: California
city: Los Angeles
country: United States
facility: UCLA CBAM Vine Street Clinic
state: California
city: Los Angeles
country: United States
facility: Charles R. Drew University of Medicine and Science (CDU) - Clinical Translational Research Center (CTRC)
state: California
city: Los Angeles
country: United States
facility: Mills Clinical Research
state: California
city: Los Angeles
country: United States
facility: The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
state: California
city: Palm Springs
country: United States
facility: BIOS Clinical Research
state: California
city: San Diego
country: United States
facility: UCSD Anti Viral Research Center
state: California
city: San Francisco
country: United States
facility: Bridge HIV at the San Francisco Department of Public Health
state: California
city: San Francisco
country: United States
facility: Optimus Medical Group
state: California
city: Aurora
country: United States
facility: University of Colorado Clinical and Translational Research Centers (CTRC)
state: Colorado
city: New Haven
country: United States
facility: Yale University, School of Medicine
state: Connecticut
city: Washington
country: United States
facility: Whitman-Walker Institute Inc.
state: District of Columbia
city: Washington
country: United States
facility: Washington Health Institute
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Therafirst Medical Center
state: Florida
city: Fort Lauderdale
country: United States
facility: Gary Richmond, MD, PA
state: Florida
city: Fort Pierce
country: United States
facility: Midway Immunology & Research Center, LLC
state: Florida
city: Miami Gardens
country: United States
facility: CAN Community Health
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine Division of Infectious Disease Research - Converge Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Sarasota
country: United States
facility: CAN Community Health
state: Florida
city: Atlanta
country: United States
facility: The Hope Clinic at Emory University
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown Infectious Disease Clinic
state: Georgia
city: Chicago
country: United States
facility: RMR Core Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago, Department of Medicine, Division of Infectious Diseases, Project WISH
state: Illinois
city: Chicago
country: United States
facility: Howard Brown Health Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Infectious Diseases Research
state: Indiana
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Louisville
country: United States
facility: Norton Infectious Disease Specialists
state: Kentucky
city: New Orleans
country: United States
facility: LSU-CrescentCare Sexual Health Center- New Orleans Community Health Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: The Fenway Institute
state: Massachusetts
city: Berkley
country: United States
facility: Be Well Medical Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Jackson
country: United States
facility: Open Arms Healthcare Center
state: Mississippi
city: Kansas City
country: United States
facility: KC CARE Health Center
state: Missouri
city: Newark
country: United States
facility: St. Michael's Medical Center
state: New Jersey
city: Somers Point
country: United States
facility: South Jersey Infectious Disease
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai- Mount Sinai Downtown
state: New York
city: Chapel Hill
country: United States
facility: NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill
state: North Carolina
city: Greensboro
country: United States
facility: Cone Health/Regional Center for Infectious Disease Research Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Penn Prevention Unit
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina, Infectious Disease Clinic
state: South Carolina
city: Columbia
country: United States
facility: Prisma Health-Midlands Clinical Research Unit
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Internal Medicine Clinic
state: South Carolina
city: Memphis
country: United States
facility: Methodist University Hospital/University of Tennessee Health Science Center, Clinical Research Center
state: Tennessee
city: Memphis
country: United States
facility: St Jude Children's Research Hospital
state: Tennessee
city: Nashville
country: United States
facility: Meharry Medical College Clinical and Transitional Research Center
state: Tennessee
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: El Paso
country: United States
facility: Centro San Vincente
state: Texas
city: Houston
country: United States
facility: The Crofoot Research Center, INC
state: Texas
city: Seattle
country: United States
facility: Ofiice of Dr. Peter Shalit, MD
state: Washington
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos JM Ramos Mejia
city: Buenos Aires
country: Argentina
facility: Fundacion Huesped
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Clinicas Mar del Plata
city: Belo Horizonte - MG
country: Brazil
facility: Unidade de Pesquisa Clinica em Vacinas (UPqVac) da Faculdade de Medicina da Universidade
city: Canela-Salvador
country: Brazil
facility: Fundação Bahiana de Infectologia
city: Manauas
country: Brazil
facility: Fundação de Medicina Tropical Doutor Heitor Vieira Dourado / Fundação Medicina Tropical do Amazonas - FMT/IMT/AM
city: Nova Iguaçu
country: Brazil
facility: Hospital General de Nova Iguaçu - HGNI
city: Porto Alegre
country: Brazil
facility: Grupo Hospitalar Conceição/ Hospital Nossa Senhora da Conceição S.A.
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Infectologia Evandro Chagas / Fundação Oswaldo Cruz - INI FIOCRUZ
city: Sao Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
city: Sao Paulo
country: Brazil
facility: Centro de Referência e Treinamento DST/AIDS
city: Sao Paulo
country: Brazil
facility: Center for Management and Research. SPDM-Paulista Association for the Development of Medicine-Hospital São Paulo/Federal
city: Guadalajara C.P.
country: Mexico
facility: Centro de Investigacion Farmaceutica Especializada de Occidente S.C.
city: Barranco
country: Peru
facility: Asociacion Civil Impacta Salud y Educacion - Sede Barranco
city: Callao
country: Peru
facility: Instituto de Medicina Tropical "Daniel Alcides Carrion", Facultad de Medicina Humana, UNMSM
city: Iquitos
country: Peru
facility: Asociacion Civil Selva Amazonica
city: Lima
country: Peru
facility: Via Libre
city: Lima
country: Peru
facility: Asociacion Civil Impacta Salud y Educacion - Sede San Miguel
city: San Juan
country: Puerto Rico
facility: Ararat Research Center
city: San Juan
country: Puerto Rico
facility: Centro Ararat- San Juan
city: Cape Town
country: South Africa
facility: Desmond Tutu Health Foundation
city: Johannesburg
country: South Africa
facility: Wits Reproductive Health and HIV Institute (Wits RHI)
city: Pretoria
country: South Africa
facility: The Aurum Institute: Pretoria Clinical Research Centre
city: Soshanguvhe
country: South Africa
facility: Setshaba Research Centre
city: Tembisa
country: South Africa
facility: The Aurum Institute Tembisa CRC, Clinic 4
city: Vincent
country: South Africa
facility: FPD-DTHF Ndevana Commuity Research Site
city: Bangkok
country: Thailand
facility: Institute of HIV Research and Innovation
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS research Centre
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital, Mahidol University
city: Chiang Mai
country: Thailand
facility: Research Institute for Health Sciences, Chiang Mai University
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital, Khon Kaen University
city: Nonthaburi
country: Thailand
facility: Bamrasnaradura Infectious Disease Institute
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: 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.