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Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection (PURPOSE 2)

Primary Purpose

Pre-Exposure Prophylaxis of HIV Infection

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Oral Lenacapavir (LEN)
F/TDF
Sub-cutaneous (SC) Lenacapavir (LEN)
Placebo SC LEN
PTM F/TDF
PTM Oral LEN
F/TAF (for US participants only)
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-Exposure Prophylaxis of HIV Infection

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 oral PrEP (including F/TDF or F/TAF) 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.

Sites / Locations

  • UAB Sexual Health Research ClinicRecruiting
  • Valleywise Community Health Center - McDowellRecruiting
  • Loma Linda University Clinical Trial Center ClinicRecruiting
  • Ruane Clinical Research Group Inc.Recruiting
  • UCLA CBAM Vine Street ClinicRecruiting
  • Charles R. Drew University of Medicine and Science (CDU) - Clinical Translational Research Center (CTRC)Recruiting
  • Mills Clinical ResearchRecruiting
  • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterRecruiting
  • Kaiser PermanenteRecruiting
  • BIOS Clinical ResearchRecruiting
  • One Community HealthRecruiting
  • Kaiser-Permanente Medical CenterRecruiting
  • UCSD Anti Viral Research CenterRecruiting
  • Bridge HIV at the San Francisco Department of Public HealthRecruiting
  • Optimus Medical GroupRecruiting
  • San Francisco AIDS Foundation
  • Kaiser PermanenteRecruiting
  • University of Colorado Clinical and Translational Research Centers (CTRC)Recruiting
  • Yale University, School of MedicineRecruiting
  • Whitman-Walker Institute Inc.Recruiting
  • Washington Health Institute
  • CAN Community Health Clinic
  • Therafirst Medical CenterRecruiting
  • Gary Richmond, MD, PA
  • Midway Immunology & Research Center, LLCRecruiting
  • CAN Community Health Clinic
  • CAN Community HealthRecruiting
  • University of Miami Miller School of Medicine Division of Infectious Disease Research - Converge MiamiRecruiting
  • Orlando Immunology CenterRecruiting
  • CAN Community HealthRecruiting
  • Triple O Research InstituteRecruiting
  • The Hope Clinic at Emory UniversityRecruiting
  • Emory UniversityRecruiting
  • Emory University Hospital Midtown Infectious Disease ClinicRecruiting
  • Mercer University, Department of Internal MedicineRecruiting
  • RMR Core Center
  • University of Illinois at Chicago, Department of Medicine, Division of Infectious Diseases, Project WISHRecruiting
  • Howard Brown Health CenterRecruiting
  • Indiana University Infectious Diseases ResearchRecruiting
  • Baptist Health LexingtonRecruiting
  • Norton Infectious Disease SpecialistsRecruiting
  • LSU-CrescentCare Sexual Health Center- New Orleans Community Health CenterRecruiting
  • Johns Hopkins University School of MedicineRecruiting
  • The Fenway InstituteRecruiting
  • Be Well Medical CenterRecruiting
  • Henry Ford HospitalRecruiting
  • Open Arms Healthcare CenterRecruiting
  • KC CARE Health CenterRecruiting
  • Huntridge Family Clinic
  • St. Michael's Medical CenterRecruiting
  • South Jersey Infectious DiseaseRecruiting
  • Icahn School of Medicine at Mount Sinai- Mount Sinai DowntownRecruiting
  • NC TraCS Institute - CTRC; University of North Carolina at Chapel HillRecruiting
  • Cone Health/Regional Center for Infectious Disease Research CenterRecruiting
  • Wake Forest University Health SciencesRecruiting
  • University of CincinnatiRecruiting
  • MetroHealth System
  • The Ohio State University Wexner Medical CenterRecruiting
  • Penn Prevention UnitRecruiting
  • Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment CenterRecruiting
  • Medical University of South Carolina, Infectious Disease ClinicRecruiting
  • Prisma Health-Midlands Clinical Research UnitRecruiting
  • Prisma Health Internal Medicine ClinicRecruiting
  • Methodist University Hospital/University of Tennessee Health Science Center, Clinical Research CenterRecruiting
  • St Jude Children's Research HospitalRecruiting
  • Meharry Medical College Clinical and Transitional Research CenterRecruiting
  • Central Texas Clinical ResearchRecruiting
  • UT Southwestern Medical CenterRecruiting
  • Centro San VincenteRecruiting
  • UT Health Science Center at Houston
  • The Crofoot Research Center, INCRecruiting
  • Ofiice of Dr. Peter Shalit, MDRecruiting
  • Hospital General de Agudos JM Ramos MejiaRecruiting
  • Fundacion HuespedRecruiting
  • Instituto de Investigaciones Clinicas Mar del PlataRecruiting
  • Unidade de Pesquisa Clinica em Vacinas (UPqVac) da Faculdade de Medicina da UniversidadeRecruiting
  • Fundação Bahiana de InfectologiaRecruiting
  • Fundação de Medicina Tropical Doutor Heitor Vieira Dourado / Fundação Medicina Tropical do Amazonas - FMT/IMT/AMRecruiting
  • Hospital General de Nova Iguaçu - HGNIRecruiting
  • Grupo Hospitalar Conceição/ Hospital Nossa Senhora da Conceição S.A.Recruiting
  • Instituto Nacional de Infectologia Evandro Chagas / Fundação Oswaldo Cruz - INI FIOCRUZRecruiting
  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São PauloRecruiting
  • Centro de Referência e Treinamento DST/AIDSRecruiting
  • Center for Management and Research. SPDM-Paulista Association for the Development of Medicine-Hospital São Paulo/FederalRecruiting
  • Asociacion Civil Impacta Salud y Educacion - Sede BarrancoRecruiting
  • Instituto de Medicina Tropical "Daniel Alcides Carrion", Facultad de Medicina Humana, UNMSMRecruiting
  • Asociacion Civil Selva AmazonicaRecruiting
  • Via LibreRecruiting
  • Asociacion Civil Impacta Salud y Educacion - Sede San MiguelRecruiting
  • Ararat Research CenterRecruiting
  • Centro Ararat- San JuanRecruiting
  • Maternal Infant Studies Center (CEMI)Recruiting
  • Desmond Tutu Health FoundationRecruiting
  • Wits Reproductive Health and HIV Institute (Wits RHI)Recruiting
  • The Aurum Institute: Pretoria Clinical Research CentreRecruiting
  • Setshaba Research CentreRecruiting
  • The Aurum Institute Tembisa CRC, Clinic 4Recruiting
  • FPD-DTHF Ndevana Commuity Research SiteRecruiting
  • Institute of HIV Research and InnovationRecruiting
  • King Chulalongkorn Memorial HospitalRecruiting
  • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS research CentreRecruiting
  • Ramathibodi Hospital, Mahidol UniversityRecruiting
  • Research Institute for Health Sciences, Chiang Mai UniversityRecruiting
  • Srinagarind Hospital, Khon Kaen UniversityRecruiting
  • Bamrasnaradura Infectious Disease InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Blinded Phase: LEN + Placebo-to-match (PTM) F/TDF

Blinded Phase: Placebo LEN + F/TDF

LEN Open-Label Extension (OLE) Phase

PK Tail Phase

Arm Description

Participants will receive the following for at least 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

Participants will receive the following for at least 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

After completion of the Blinded phase, participants will be offered entry into the LEN OLE Phase. Participants randomized to LEN will continue to receive SC LEN 927 mg every 26 weeks for a total of 2 doses. Participants randomized to F/TDF will receive SC LEN 927 mg on OLE Day 1, OLE Week 26, and will also receive oral LEN 600 mg on OLE Days 1 and 2.

At the completion of the LEN OLE phase, participants will transition into the PK Tail phase. Additionally, participants that prematurely discontinue the study drug during blinded phase and participants that were randomized to LEN who choose not to continue in the LEN OLE Phase are also eligible to 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 beginning 26 weeks after the last injection of LEN.

Outcomes

Primary Outcome Measures

Incidence Phase: Background HIV Incidence Reported Per 100-Person-Years (PY)
Randomized Phase: Background HIV Incidence Reported Per 100-PY of Follow-up

Secondary Outcome Measures

HIV Incidence Among Participants While Adherent to Study Drug
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities

Full Information

First Posted
May 28, 2021
Last Updated
October 23, 2023
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04925752
Brief Title
Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection
Acronym
PURPOSE 2
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2021 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
April 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Exposure Prophylaxis of HIV Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blinded Phase: LEN + Placebo-to-match (PTM) F/TDF
Arm Type
Experimental
Arm Description
Participants will receive the following for at least 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
Arm Title
Blinded Phase: Placebo LEN + F/TDF
Arm Type
Experimental
Arm Description
Participants will receive the following for at least 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
Arm Title
LEN Open-Label Extension (OLE) Phase
Arm Type
Experimental
Arm Description
After completion of the Blinded phase, participants will be offered entry into the LEN OLE Phase. Participants randomized to LEN will continue to receive SC LEN 927 mg every 26 weeks for a total of 2 doses. Participants randomized to F/TDF will receive SC LEN 927 mg on OLE Day 1, OLE Week 26, and will also receive oral LEN 600 mg on OLE Days 1 and 2.
Arm Title
PK Tail Phase
Arm Type
Experimental
Arm Description
At the completion of the LEN OLE phase, participants will transition into the PK Tail phase. Additionally, participants that prematurely discontinue the study drug during blinded phase and participants that were randomized to LEN who choose not to continue in the LEN OLE Phase are also eligible to 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 beginning 26 weeks after the last injection of LEN.
Intervention Type
Drug
Intervention Name(s)
Oral Lenacapavir (LEN)
Other Intervention Name(s)
GS-6207
Intervention Description
Tablets administered orally without regard to food
Intervention Type
Drug
Intervention Name(s)
F/TDF
Other Intervention Name(s)
Truvada®
Intervention Description
Tablets administered orally
Intervention Type
Drug
Intervention Name(s)
Sub-cutaneous (SC) Lenacapavir (LEN)
Other Intervention Name(s)
GS-6207
Intervention Description
Administered via SC injections
Intervention Type
Drug
Intervention Name(s)
Placebo SC LEN
Intervention Description
Administered via SC injections
Intervention Type
Drug
Intervention Name(s)
PTM F/TDF
Intervention Description
Tablets administered orally
Intervention Type
Drug
Intervention Name(s)
PTM Oral LEN
Intervention Description
Tablets administered orally
Intervention Type
Drug
Intervention Name(s)
F/TAF (for US participants only)
Intervention Description
F/TAF tablets administered orally once daily
Primary Outcome Measure Information:
Title
Incidence Phase: Background HIV Incidence Reported Per 100-Person-Years (PY)
Time Frame
At Screening
Title
Randomized Phase: Background HIV Incidence Reported Per 100-PY of Follow-up
Time Frame
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 Outcome Measure Information:
Title
HIV Incidence Among Participants While Adherent to Study Drug
Time Frame
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)
Title
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Time Frame
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)
Title
Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
Time Frame
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)

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Cisgender male, Transgender male, Transgender female, and Gender non-binary
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 oral PrEP (including F/TDF or F/TAF) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilead Clinical Study Information Center
Phone
1-833-445-3230 (GILEAD-0)
Email
GileadClinicalTrials@gilead.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
UAB Sexual Health Research Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
Valleywise Community Health Center - McDowell
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Individual Site Status
Recruiting
Facility Name
Loma Linda University Clinical Trial Center Clinic
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Name
Ruane Clinical Research Group Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Individual Site Status
Recruiting
Facility Name
UCLA CBAM Vine Street Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90038
Country
United States
Individual Site Status
Recruiting
Facility Name
Charles R. Drew University of Medicine and Science (CDU) - Clinical Translational Research Center (CTRC)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Individual Site Status
Recruiting
Facility Name
Mills Clinical Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
Individual Site Status
Recruiting
Facility Name
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Individual Site Status
Recruiting
Facility Name
BIOS Clinical Research
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Individual Site Status
Recruiting
Facility Name
One Community Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95811
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser-Permanente Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Individual Site Status
Recruiting
Facility Name
UCSD Anti Viral Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Name
Bridge HIV at the San Francisco Department of Public Health
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Individual Site Status
Recruiting
Facility Name
Optimus Medical Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Individual Site Status
Recruiting
Facility Name
San Francisco AIDS Foundation
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States
Individual Site Status
Withdrawn
Facility Name
Kaiser Permanente
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado Clinical and Translational Research Centers (CTRC)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale University, School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Name
Whitman-Walker Institute Inc.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington Health Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20017
Country
United States
Individual Site Status
Completed
Facility Name
CAN Community Health Clinic
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Therafirst Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Name
Gary Richmond, MD, PA
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Individual Site Status
Completed
Facility Name
Midway Immunology & Research Center, LLC
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Individual Site Status
Recruiting
Facility Name
CAN Community Health Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
CAN Community Health
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33055
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Miami Miller School of Medicine Division of Infectious Disease Research - Converge Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Name
CAN Community Health
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34237
Country
United States
Individual Site Status
Recruiting
Facility Name
Triple O Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Recruiting
Facility Name
The Hope Clinic at Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University Hospital Midtown Infectious Disease Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Name
Mercer University, Department of Internal Medicine
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Individual Site Status
Recruiting
Facility Name
RMR Core Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Completed
Facility Name
University of Illinois at Chicago, Department of Medicine, Division of Infectious Diseases, Project WISH
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Howard Brown Health Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60613
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana University Infectious Diseases Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Recruiting
Facility Name
Norton Infectious Disease Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Individual Site Status
Recruiting
Facility Name
LSU-CrescentCare Sexual Health Center- New Orleans Community Health Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Individual Site Status
Recruiting
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Name
The Fenway Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Be Well Medical Center
City
Berkley
State/Province
Michigan
ZIP/Postal Code
48072
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Open Arms Healthcare Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Individual Site Status
Recruiting
Facility Name
KC CARE Health Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Name
Huntridge Family Clinic
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Individual Site Status
Completed
Facility Name
St. Michael's Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Individual Site Status
Recruiting
Facility Name
South Jersey Infectious Disease
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Individual Site Status
Recruiting
Facility Name
Icahn School of Medicine at Mount Sinai- Mount Sinai Downtown
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Name
Cone Health/Regional Center for Infectious Disease Research Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Name
MetroHealth System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Individual Site Status
Withdrawn
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
Penn Prevention Unit
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina, Infectious Disease Clinic
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Prisma Health-Midlands Clinical Research Unit
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Individual Site Status
Recruiting
Facility Name
Prisma Health Internal Medicine Clinic
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Name
Methodist University Hospital/University of Tennessee Health Science Center, Clinical Research Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Individual Site Status
Recruiting
Facility Name
St Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Individual Site Status
Recruiting
Facility Name
Meharry Medical College Clinical and Transitional Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States
Individual Site Status
Recruiting
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
Centro San Vincente
City
El Paso
State/Province
Texas
ZIP/Postal Code
79915
Country
United States
Individual Site Status
Recruiting
Facility Name
UT Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
Individual Site Status
Completed
Facility Name
The Crofoot Research Center, INC
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Individual Site Status
Recruiting
Facility Name
Ofiice of Dr. Peter Shalit, MD
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Name
Hospital General de Agudos JM Ramos Mejia
City
Buenos Aires
ZIP/Postal Code
1072
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Fundacion Huesped
City
Buenos Aires
ZIP/Postal Code
1202
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto de Investigaciones Clinicas Mar del Plata
City
Buenos Aires
ZIP/Postal Code
B7600
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Unidade de Pesquisa Clinica em Vacinas (UPqVac) da Faculdade de Medicina da Universidade
City
Belo Horizonte - MG
ZIP/Postal Code
30130-100
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundação Bahiana de Infectologia
City
Canela-Salvador
ZIP/Postal Code
40110-060
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundação de Medicina Tropical Doutor Heitor Vieira Dourado / Fundação Medicina Tropical do Amazonas - FMT/IMT/AM
City
Manauas
ZIP/Postal Code
69040-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital General de Nova Iguaçu - HGNI
City
Nova Iguaçu
ZIP/Postal Code
26030-380
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Grupo Hospitalar Conceição/ Hospital Nossa Senhora da Conceição S.A.
City
Porto Alegre
ZIP/Postal Code
RS 91350 200
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto Nacional de Infectologia Evandro Chagas / Fundação Oswaldo Cruz - INI FIOCRUZ
City
Rio de Janeiro
ZIP/Postal Code
21040-360
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
City
Sao Paulo
ZIP/Postal Code
01246-903
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro de Referência e Treinamento DST/AIDS
City
Sao Paulo
ZIP/Postal Code
04121-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Center for Management and Research. SPDM-Paulista Association for the Development of Medicine-Hospital São Paulo/Federal
City
Sao Paulo
ZIP/Postal Code
06519-332
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Asociacion Civil Impacta Salud y Educacion - Sede Barranco
City
Barranco
ZIP/Postal Code
15063
Country
Peru
Individual Site Status
Recruiting
Facility Name
Instituto de Medicina Tropical "Daniel Alcides Carrion", Facultad de Medicina Humana, UNMSM
City
Callao
ZIP/Postal Code
7006
Country
Peru
Individual Site Status
Recruiting
Facility Name
Asociacion Civil Selva Amazonica
City
Iquitos
Country
Peru
Individual Site Status
Recruiting
Facility Name
Via Libre
City
Lima
ZIP/Postal Code
15001
Country
Peru
Individual Site Status
Recruiting
Facility Name
Asociacion Civil Impacta Salud y Educacion - Sede San Miguel
City
Lima
ZIP/Postal Code
15088
Country
Peru
Individual Site Status
Recruiting
Facility Name
Ararat Research Center
City
San Juan
ZIP/Postal Code
00717
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Centro Ararat- San Juan
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Maternal Infant Studies Center (CEMI)
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Desmond Tutu Health Foundation
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Wits Reproductive Health and HIV Institute (Wits RHI)
City
Johannesburg
ZIP/Postal Code
2038
Country
South Africa
Individual Site Status
Recruiting
Facility Name
The Aurum Institute: Pretoria Clinical Research Centre
City
Pretoria
ZIP/Postal Code
87
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Setshaba Research Centre
City
Soshanguvhe
ZIP/Postal Code
0152
Country
South Africa
Individual Site Status
Recruiting
Facility Name
The Aurum Institute Tembisa CRC, Clinic 4
City
Tembisa
ZIP/Postal Code
1632
Country
South Africa
Individual Site Status
Recruiting
Facility Name
FPD-DTHF Ndevana Commuity Research Site
City
Vincent
ZIP/Postal Code
5217
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Institute of HIV Research and Innovation
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS research Centre
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Ramathibodi Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Institute for Health Sciences, Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Srinagarind Hospital, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Bamrasnaradura Infectious Disease Institute
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35657826
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.
Results Reference
derived
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-528-9023
Description
Gilead Clinical Trials Website

Learn more about this trial

Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection

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