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

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

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

The primary objective of this study is to evaluate the efficacy of LEN for HIV-1 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pre-Exposure Prophylaxis of HIV Infection
• Intervention / Treatment: Drug: Oral Lenacapavir (LEN); Drug: PTM F/TDF; Drug: Placebo SC LEN; Drug: PTM Oral LEN; Drug: F/TDF; Drug: Sub-cutaneous (SC) Lenacapavir (LEN); Drug: F/TAF (for US participants only)

• Study Type: Interventional
• Enrollment (Actual): 3292
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1202
    • Fundación Huésped
  • Buenos Aires, Argentina, 1072
    • Hospital General de Agudos JM Ramos Mejia
  • Buenos Aires, Argentina, B7600
    • Instituto de Investigaciones Clínicas Mar del Plata
• Brazil
  • Belo Horizonte - MG, Brazil, 30130-100
    • Unidade de Pesquisa Clinica em Vacinas (UPqVac) da Faculdade de Medicina da Universidade
  • Canela-Salvador, Brazil, 40110-060
    • Fundação Bahiana de Infectologia
  • Manauas, Brazil, 69040-000
    • Fundação de Medicina Tropical Doutor Heitor Vieira Dourado / Fundação Medicina Tropical do Amazonas - FMT/IMT/AM
  • Nova Iguaçu, Brazil, 26030-380
    • Hospital General de Nova Iguaçu - HGNI
  • Porto Alegre, Brazil, RS 91350 200
    • Grupo Hospitalar Conceição/ Hospital Nossa Senhora da Conceição S.A.
  • Rio de Janeiro, Brazil, 21040-360
    • Instituto Nacional de Infectologia Evandro Chagas / Fundação Oswaldo Cruz - INI FIOCRUZ
  • São Paulo, Brazil, 01246-903
    • Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
  • São Paulo, Brazil, 04121-000
    • Centro de Referência e Treinamento DST/AIDS
  • São Paulo, Brazil, 06519-332
    • Center for Management and Research. SPDM-Paulista Association for the Development of Medicine-Hospital São Paulo/Federal
• Mexico
  • Guadalajara C.P., Mexico, 44160
    • Centro de Investigacion Farmaceutica Especializada de Occidente S.C.
• Peru
  • Barranco, Peru, 15063
    • Asociacion Civil Impacta Salud y Educacion - Sede Barranco
  • Callao, Peru, 7006
    • Instituto de Medicina Tropical "Daniel Alcides Carrion", Facultad de Medicina Humana, UNMSM
  • Iquitos, Peru
    • Asociacion Civil Selva Amazonica
  • Lima, Peru, 15001
    • Via Libre
  • Lima, Peru, 15088
    • Asociacion Civil Impacta Salud y Educacion - Sede San Miguel
• Puerto Rico
  • PR
    • San Juan, PR, Puerto Rico, 00717
      • Ararat Research Center
    • San Juan, PR, Puerto Rico, 00909
      • Centro Ararat- San Juan
• South Africa
  • Cape Town, South Africa, 7925
    • Desmond Tutu Health Foundation
  • Johannesburg, South Africa, 2038
    • Wits Reproductive Health and HIV Institute (Wits RHI)
  • Pretoria, South Africa, 87
    • The Aurum Institute: Pretoria Clinical Research Centre
  • Soshanguvhe, South Africa, 0152
    • Setshaba Research Centre
  • Tembisa, South Africa, 1632
    • The Aurum Institute Tembisa CRC, Clinic 4
  • Vincent, South Africa, 5217
    • FPD-DTHF Ndevana Commuity Research Site
• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital, Mahidol University
  • Bangkok, Thailand, 10330
    • Institute of HIV Research and Innovation
  • Bangkok, Thailand, 10330
    • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS research Centre
  • Chiang Mai, Thailand, 50200
    • Research Institute for Health Sciences, Chiang Mai University
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital, Khon Kaen University
  • Nonthaburi, Thailand, 11000
    • Bamrasnaradura Infectious Disease Institute
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • UAB Sexual Health Research Clinic
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Clinical Trial Center Clinic
    • Los Angeles, California, United States, 90069
      • Mills Clinical Research
    • Los Angeles, California, United States, 90036
      • Ruane Clinical Research Group Inc.
    • Los Angeles, California, United States, 90038
      • UCLA CBAM Vine Street Clinic
    • Los Angeles, California, United States, 90059
      • Charles R. Drew University of Medicine and Science (CDU) - Clinical Translational Research Center (CTRC)
    • Los Angeles, California, United States, 90502
      • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    • Palm Springs, California, United States, 92262
      • BIOS Clinical Research
    • San Diego, California, United States, 92103
      • UCSD Anti Viral Research Center
    • San Francisco, California, United States, 94102
      • Optimus Medical Group
    • San Francisco, California, United States, 94102
      • Bridge HIV at the San Francisco Department of Public Health
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Clinical and Translational Research Centers (CTRC)
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University, School of Medicine
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20009
      • Whitman-Walker Institute Inc.
    • Washington D.C., District of Columbia, United States, 20017
      • Washington Health Institute
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Therafirst Medical Center
    • Fort Lauderdale, Florida, United States, 33316
      • Gary Richmond, MD, PA
    • Ft. Pierce, Florida, United States, 34982
      • Midway Immunology & Research Center, LLC
    • Jacksonville, Florida, United States, 32207
      • CAN Community Health Clinic
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine Division of Infectious Disease Research - Converge Miami
    • Miami Gardens, Florida, United States, 33055
      • CAN Community Health
    • Orlando, Florida, United States, 32803
      • Orlando Immunology Center
    • Sarasota, Florida, United States, 34237
      • CAN Community Health
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown Infectious Disease Clinic
    • Atlanta, Georgia, United States, 30030
      • The Hope Clinic at Emory University
  • Illinois
    • Chicago, Illinois, United States, 60613
      • Howard Brown Health Center
    • Chicago, Illinois, United States, 60612
      • RMR Core Center
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago, Department of Medicine, Division of Infectious Diseases, Project WISH
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Infectious Diseases Research
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
    • Louisville, Kentucky, United States, 40241
      • Norton Infectious Disease Specialists
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • LSU-CrescentCare Sexual Health Center- New Orleans Community Health Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University School of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • The Fenway Institute
  • Michigan
    • Berkley, Michigan, United States, 48072
      • Be Well Medical Center
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Open Arms HealthCare Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • KC Care Health Center
  • New Jersey
    • Newark, New Jersey, United States, 07102
      • St. Michael's Medical Center
    • Somers Point, New Jersey, United States, 08244
      • South Jersey Infectious Disease
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai- Mount Sinai Downtown
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill
    • Greensboro, North Carolina, United States, 27401
      • Cone Health/Regional Center for Infectious Disease Research Center
    • Winston-Salem, North Carolina, United States, 27103
      • Wake Forest University Health Sciences
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Prevention Unit
    • Philadelphia, Pennsylvania, United States, 19107
      • Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina, Infectious Disease Clinic
    • Columbia, South Carolina, United States, 29203
      • Prisma Health-Midlands Clinical Research Unit
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Internal Medicine Clinic
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St Jude Children's Research Hospital
    • Memphis, Tennessee, United States, 38103
      • Methodist University Hospital/University of Tennessee Health Science Center, Clinical Research Center
    • Nashville, Tennessee, United States, 37208
      • Meharry Medical College Clinical and Transitional Research Center
  • Texas
    • Austin, Texas, United States, 78705
      • Central Texas Clinical Research
    • El Paso, Texas, United States, 79915
      • Centro San Vincente
    • Houston, Texas, United States, 77098
      • The Crofoot Research Center, INC
    • Houston, Texas, United States, 77009
      • UT Health Science Center at Houston
  • Washington
    • Seattle, Washington, United States, 98104
      • Ofiice of Dr. Peter Shalit, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Randomized Blinded Phase: LEN + Placebo-to-match (PTM) F/TDF; Participants will receive the following for up to approximately 52 weeks: Subcutaneous (SC) lenacapavir (LEN) 927 mg every 26 weeks; Oral PTM Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) once daily; Oral LEN 600 mg on Days 1 and 2 Participants will receive oral LEN if SC injections are not available.	Drug: Oral Lenacapavir (LEN); Tablets administered orally without regard to food; Other Names: GS-6207; Drug: PTM F/TDF; Tablets administered orally; Drug: Sub-cutaneous (SC) Lenacapavir (LEN); Administered via SC injections; Other Names: GS-6207; Yeztugo
Experimental: Randomized Blinded Phase: Placebo LEN + F/TDF; Participants will receive the following for up to approximately 52 weeks: SC LEN placebo every 26 weeks; Oral F/TDF 200/300 mg once daily; PTM Oral LEN on Days 1 and 2 Participants will receive oral LEN placebo if SC injections are not available.	Drug: Placebo SC LEN; Administered via SC injections; Drug: PTM Oral LEN; Tablets administered orally; Drug: F/TDF; Tablets administered orally; Other Names: Truvada®
Experimental: 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.	Drug: Oral Lenacapavir (LEN); Tablets administered orally without regard to food; Other Names: GS-6207; Drug: Sub-cutaneous (SC) Lenacapavir (LEN); Administered via SC injections; Other Names: GS-6207; Yeztugo
Experimental: 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.	Drug: F/TDF; Tablets administered orally; Other Names: Truvada®; Drug: F/TAF (for US participants only); F/TAF tablets administered orally once daily; Other Names: Descovy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence Phase: Recent Infection Testing Algorithm (RITA) Estimate of the Background Human Immunodeficiency-1 Virus Infection Incidence Rate (bHIV) Per 100 Person Years (PY)	bHIV per 100 PY in the Incidence Phase was calculated using RITA. The RITA incorporated HIV-1 testing results and recency assay testing results to estimate the bHIV. Recency assay testing was performed for participants in the All Screened Set found to have HIV-1 infection at the Incidence Phase Screening Visit as defined below. Participants were considered to have recent HIV-1 infection if the normalized optical density (ODn) was below 1.5 threshold using the Sedia limiting antigen avidity enzyme immunoassay (LAg-EIA) and the HIV-1 RNA (viral load) was > 75 copies/mL of blood. HIV-1 infection was defined as participants having at least one of the following central lab results at the Incidence Phase screening visit: Positive HIV-1/2 differentiation Ab, OR; Positive HIV-1 ribonucleic acid (RNA) qualitative test, OR; HIV-1 RNA quantitative test ≥200 copies/mL.	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)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN Compared to F/TDF	HIV-1 incidence per 100 PY was calculated as the number of participants who acquired HIV-1 divided by the total of a) for participants not diagnosed with HIV-1, sum of all duration of follow-up time in years, while at risk of HIV-1 infection (where a year is 365.25 days) and b) for participants diagnosed with HIV-1, sum of all duration of follow-up time up to confirmed HIV-1 diagnoses. HIV-1 diagnosis was determined by an HIV adjudication committee who reviewed potential HIV-1 infection events in the randomized participants. The committee, in a blinded, consistent, and unbiased manner, determined whether HIV test results confirmed HIV-1 infection and determined the date of diagnosis for each case, defined as the date of the earliest study visit with evidence of HIV infection considering both prospective HIV testing and back-testing of archived samples.	Up to 149 weeks
Randomized Blinded Phase: HIV-1 Incidence Among Participants Adherent to LEN	A participant was defined as adherent to LEN if they have received all per-protocol administrations of LEN within 28 weeks since the previous administration. The incidence of HIV-1 infection per 100 PY calculation is defined in outcome measure #2.	Up to 149 weeks
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)	TEAEs were defined as 1 or both of the following: Any adverse events (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. An 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.	Up to 4 years
Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities	Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any post-baseline visit, up to and including the last exposure date for participants who permanently discontinued study drug, or the last available date in the database snapshot for participants who were still on treatment at the time of an analysis.	Up to 4 years

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

General Publications

• Kelley CF, Acevedo-Quiñones M, Agwu AL, et al. Twice-yearly lenacapavir PrEP in cisgender gay men, transgender women and men, and gender-diverse people (PURPOSE 2). Presented at: HIV Drug Therapy Glasgow; November 10-13, 2024; Glasgow, United Kingdom.
• Kelley CF, Acevedo-Quinones M, Agwu AL, Avihingsanon A, Benson P, Blumenthal J, Brinson C, Brites C, Cahn P, Cantos VD, Clark J, Clement M, Creticos C, Crofoot G, Diaz RS, Doblecki-Lewis S, Gallardo-Cartagena JA, Gaur A, Grinsztejn B, Hassler S, Hinojosa JC, Hodge T, Kaplan R, Lacerda M, LaMarca A, Losso MH, Valdez Madruga J, Mayer KH, Mills A, Mounzer K, Ndlovu N, Novak RM, Perez Rios A, Phanuphak N, Ramgopal M, Ruane PJ, Sanchez J, Santos B, Schine P, Schreibman T, Spencer LY, Van Gerwen OT, Vasconcelos R, Vasquez JG, Zwane Z, Cox S, Deaton C, Ebrahimi R, Wong P, Singh R, Brown LB, Carter CC, Das M, Baeten JM, Ogbuagu O; PURPOSE 2 Study Team. Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons. N Engl J Med. 2025 Apr 3;392(13):1261-1276. doi: 10.1056/NEJMoa2411858. Epub 2024 Nov 27.
• 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.

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Actual): August 21, 2024
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Immune System Diseases; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Infections; Communicable Diseases; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Nucleic Acids, Nucleotides, and Nucleosides; Purines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Organophosphorus Compounds; Nucleosides; Deoxyribonucleosides; Organophosphonates; Adenine; Drug Combinations; Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; lenacapavir; emtricitabine tenofovir alafenamide
• Other Study ID Numbers: GS-US-528-9023; DOH-27-102021-6681 (Other Identifier: South African National Clinical Trial Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No