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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04925752
Registration number
NCT04925752
Ethics application status
Date submitted
28/05/2021
Date registered
14/06/2021
Date last updated
17/09/2025
Titles & IDs
Public title
Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection
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Scientific 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
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Secondary ID [1]
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DOH-27-102021-6681
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Secondary ID [2]
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GS-US-528-9023
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Universal Trial Number (UTN)
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Trial acronym
PURPOSE 2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pre-Exposure Prophylaxis of HIV Infection
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Oral Lenacapavir (LEN)
Treatment: Drugs - F/TDF
Treatment: Drugs - Sub-cutaneous (SC) Lenacapavir (LEN)
Treatment: Drugs - Placebo SC LEN
Treatment: Drugs - PTM F/TDF
Treatment: Drugs - PTM Oral LEN
Treatment: Drugs - F/TAF (for US participants only)
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.
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.
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.
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.
Treatment: Drugs: Oral Lenacapavir (LEN)
Tablets administered orally without regard to food
Treatment: Drugs: F/TDF
Tablets administered orally
Treatment: Drugs: Sub-cutaneous (SC) Lenacapavir (LEN)
Administered via SC injections
Treatment: Drugs: Placebo SC LEN
Administered via SC injections
Treatment: Drugs: PTM F/TDF
Tablets administered orally
Treatment: Drugs: PTM Oral LEN
Tablets administered orally
Treatment: Drugs: F/TAF (for US participants only)
F/TAF tablets administered orally once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence Phase: Recent Infection Testing Algorithm (RITA) Estimate of the Background Human Immunodeficiency-1 Virus Infection Incidence Rate (bHIV) Per 100 Person Years (PY)
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Assessment method [1]
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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.
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Timepoint [1]
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Incidence Phase Screening Visit (Day 1)
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Primary outcome [2]
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Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN Compared to Background HIV (bHIV, Participants in All Screened Set)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 149 weeks
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Secondary outcome [1]
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Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN Compared to F/TDF
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 149 weeks
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Secondary outcome [2]
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Randomized Blinded Phase: HIV-1 Incidence Among Participants Adherent to LEN
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 149 weeks
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Secondary outcome [3]
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Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 4 years
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Secondary outcome [4]
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Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 4 years
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Eligibility
Key inclusion criteria
Key
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).
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/06/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/05/2028
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Actual
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Sample size
Target
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Accrual to date
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Final
3292
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Recruitment in Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04925752
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Trial related presentations / 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.
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Gilead Study Director
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Gilead Sciences
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/52/NCT04925752/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/52/NCT04925752/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04925752
Download to PDF