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

Study acronym: PURPOSE 2
StatusActive, Not Recruiting
PhasePhase 3
Started2021-06-28
View on ClinicalTrials.gov ↗

Amendment history

2025-12-05
Study Status, Contacts/Locations v41
Completion date2028-05→2028-08
Study sites91→93
2025-08-28
Study Status, Outcome Measures, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events v40
Results first postednot stated→2025-09-17
Secondary endpointsdetails revised at 4 of 4 entries
2025-07-23
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, References, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events v39
Primary completion date2024-08-05→2024-08-21
Enrollment target3295→3292
Secondary endpoints3 to 4 entries
NumberRandomized ofBlinded Participants with Diagnosis ofPhase: HIV-1 Incidence Reported Per 100 PY for LEN Compared to F/TDF Randomized Blinded Phase: HIV-1 Incidence Among Participants While Adherent to Study DrugLEN Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Primary endpoints2 entries, revised
Incidence Phase: Recent Infection Testing Algorithm (RITA) Estimate of the Background HIVHuman Immunodeficiency-1 Virus Infection Incidence perRate (bHIV) Per 100- Person- Years (PY) Randomized Blinded Phase: Number of Participants with Diagnosis of HIV-1 InfectionIncidence Reported Per 100 PY for LEN Compared to Background HIV (bHIV, Participants in All Screened Set)
Publications3 to 4 entries
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.
2024-12-17
Study Status, Arms and Interventions v38
Re-verified, no change to tracked fields
2024-10-23
Study Status v37
Primary completion dateestimated 2024-12→confirmed 2024-08-05
Show 36 earlier versions
2024-07-11
Study Status v36
Primary completion date2025-01→2024-12
Completion date2027-04→2028-05
2023-12-20
Recruiting→Active, Not Recruiting Study Status, Study Design, Outcome Measures, Eligibility, Contacts/Locations v35
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 3000→confirmed 3295
Study sites106→91
Eligibility criteria+47 characters
[...] creening and no prior HIV-1 testing within the last 3 months. Sexually active with ≥ 1 partner assigned male at birth (co [...] ss 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 RNA quantitative nucleic acid amplification testing (NAAT). Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min at [...] the Cockcroft-Gault formula for creatinine clearance (CLcr). Key Exclusion Criteria: Inciden [...] [...]
Secondary endpoints3 entries, revised
Number of Participants with Diagnosis of HIV Incidence Among Participants While Adherent to Study Drug
Primary endpoints2 entries, revised
Incidence Phase: Background HIV Incidence Reported Perper 100-Person-Years (PY) Randomized Phase: Background HIV Incidence Reported Per 100-PYNumber of FollowParticipants with Diagnosis of HIV-up1 Infection
2023-11-22
Study Status, Contacts/Locations v34
Study sites105→106
2023-10-23
Study Status, Contacts/Locations v33
Study sites98→105
2023-09-06
Study Status, Contacts/Locations v32
Study sites91→98
2023-08-10
Study Status v31
Primary completion date2024-01→2025-01
2023-08-01
Study Status, Contacts/Locations v30
Study sites88→91
2023-07-03
Study Status, Contacts/Locations v29
Study sites87→88
2023-06-08
Study Status, Contacts/Locations v28
Study sites86→87
2023-05-18
Study Status, Contacts/Locations v27
Study sites85→86
2023-04-25
Study Status, Contacts/Locations v26
Study sites84→85
2023-03-28
Study Identification, Study Status, Study Description, Contacts/Locations v25
Study sitesdetails revised at 1 of 84 sites
Study title-26 characters
Study to Assess the Effectiveness and Safety of Lenacapavir for Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection
2023-02-17
Study Status, Contacts/Locations v24
Study sites81→84
2023-01-30
Study Status, Contacts/Locations v23
Study sites79→81
2023-01-16
Study Status v22
Re-verified, no change to tracked fields
2022-12-20
Study Status, Contacts/Locations v21
Study sitesdetails revised at 1 of 79 sites
2022-12-09
Study Status v20
Re-verified, no change to tracked fields
2022-11-22
Study Status, Contacts/Locations v19
Study sites76→79
2022-11-04
Study Status, Contacts/Locations v18
Study sites74→76
2022-10-17
Study Status, Contacts/Locations v17
Study sites70→74
2022-09-26
Study Status, Contacts/Locations v16
Study sites65→70
2022-09-06
Study Status, Contacts/Locations v15
Study sites61→65
2022-08-17
Study Status, Contacts/Locations v14
Study sites59→61
2022-07-25
Study Status, Contacts/Locations v13
Study sites53→59
2022-06-28
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v12
Trial statusActive, Not Recruiting→Recruiting
Study sites52→53
2022-05-06
Study Identification, Study Status, Study Description, Arms and Interventions, Eligibility v11
Eligibility criteria+187 characters
[...] s receptive anal sex with ≥ 2 partners in the last 12 weeks Documented historyHistory of syphilis, rectal gonorrhea, or rectal chlamydia in the l [...] andomized Phase Negative local rapid fourth generation HIV-1/2 Ab/Ag test confirmed with, 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 [...] earance (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 [...] [...]
2022-02-23
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v10
InterventionsF/TDF (Drug), Oral Lenacapavir (LEN) (Drug), PTM F/TDF (Drug), PTM Oral LEN (Drug), Placebo SC LEN (Drug), Sub-cutaneous (SC) Lenacapavir…→F/TAF (for US participants only) (Drug), F/TDF (Drug), Oral Lenacapavir (LEN) (Drug), PTM F/TDF (Drug), PTM Oral LEN (Drug), Placebo SC LEN…
Eligibility criteria+85 characters
[...] g-acting systemic PrEP (including cabotegravir or islatravir trials) Prior recipient of an HIV vaccine Randomized Phase Acute v [...] 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.
Secondary endpointsdetails revised at 3 of 3 entries
2022-01-11
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v9
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 52 of 52 sites
2022-01-04
Study Status, Contacts/Locations v8
Study sites32→52
2021-12-09
Study Status, Eligibility, Contacts/Locations v7
Study sites27→32
2021-11-15
Study Identification, Study Status, Contacts/Locations, References v6
Study sites18→27
2021-10-12
Study Status, Contacts/Locations v5
Study sites15→18
2021-09-22
Study Status, Contacts/Locations v4
Study sites11→15
2021-08-20
Study Status, Contacts/Locations v3
Study sites3→11
2021-07-12
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-06→confirmed 2021-06-28
Study sites0→3
2021-06-24
Study Status v1
Re-verified, no change to tracked fields
2021-06-11
Original filing
Gilead Sciences
107 trials monitored
See 8 trials at risk
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.
Trial Details
NCT Number NCT04925752
Lead Sponsor Gilead Sciences
Conditions Pre-Exposure Prophylaxis of HIV Infection
Enrollment 3,292 participants
Start Date 2021-06-28
Primary Completion 2024-08-21 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2025-12-23