2026-07-15
minor
Study Status, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events v35
Secondary endpoints5 entries, revised
Randomized Blinded Phase: Percentage of Participants ExperiencingWith ClinicallyGrade Significant3 or Higher Laboratory Abnormalities
2026-03-10
minor
Study Status, Arms and Interventions v34
Re-verified, no change to tracked fields
2025-06-27
minor
Study Status, Arms and Interventions, Outcome Measures, Outcome Measures (Results) v33
Secondary endpointsdetails revised at 1 of 5 entries
2025-05-20
minor
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, References, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, Limitations and Caveats v31
Primary completion date2024-05-08→2024-05-27
Completion date2027-07→2028-01
Study arms6→5
Eligibility criteria+28 characters
[...] sion Criteria:
Prior receipt of an HIV vaccine.
Prior use of any long-acting systemic HIV pre-exposure prophylaxis (PrEP) or orprior HIV PEP (postexposure prophylaxis (PEP) in the past 12 weeks.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Secondary endpoints3 to 5 entries
Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN, F/TAF and F/TDF
Randomized Blinded Phase: HIV-1 Incidence Among Participants WhileAdherent to LEN
Randomized Blinded Phase: Percentage of Participants Adherent to StudyF/TAF Drugin HIV-1 Diagnosed Participants and Their Matched Controls
Randomized Blinded Phase: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Randomized Blinded Phase: Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
Primary endpoints2 entries, revised
Incidence Phase: Recent Infection Testing Algorithm (RITA) Estimate of the Background Human Immunodeficiency-1 Virus Infection Incidence Rate (bHIV) Per 100 Person Years (PY)
Randomized Blinded Phase: HIV-1 Incidence Reported Per 100-Person-Years (PY)
Randomized Phase: HIV Incidence Reported Per 100-PY offor Follow-upLEN and F/TAF Compared to Participants in All Screened Set
Publicationsdetails revised at 1 of 1 entry
Show 30 earlier versions
2025-02-21
minor
Study Status, Arms and Interventions v30
Re-verified, no change to tracked fields
2024-09-13
minor
Study Status v29
Primary completion dateestimated 2024-09→confirmed 2024-05-08
2024-02-26
minor
Study Status, Study Design, Eligibility v28
Enrollment target5639→5368
Eligibility criteria+51 characters
[...] unodeficiency virus (HIV)-1 testing within the last 3 months.
Sexually active (has had > 1 vaginal intercourse within the last 3 months) with cisgender male individuals (CGM).
Randomized Phase
Negative fourth generation HIV-1 antibody (Ab)/antigen (Ag) test confirmed with central HIV-1 testing.
Estimated glomerular filtration rate (GFR) ≥ 60 mL/min at screening.
Body weight ≥ 35 kg.
Key Exclusion Criteria:
Prior receipt of an HIV vaccine.
Prior use of long-acting systemic HIV pre-exposure prophylaxis (PrEP) or or HIV PEP (postexposure prophylaxis).
Note: Other protocol defined Inclusion/Exclus [...]
2023-10-09
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v27
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 5010→confirmed 5639
Study sitesdetails revised at 28 of 28 sites
2023-09-22
minor
Study Status v26
Re-verified, no change to tracked fields
2023-08-10
minor
Study Status v25
Primary completion date2024-03→2024-09
2023-07-25
minor
Study Status, Contacts/Locations v24
Study sitesdetails revised at 25 of 28 sites
2023-06-22
minor
Study Status v23
Re-verified, no change to tracked fields
2023-05-30
minor
Study Status, Contacts/Locations v22
2023-04-18
minor
Study Status, Contacts/Locations v21
Study sitesdetails revised at 1 of 27 sites
2023-03-30
minor
Study Identification, Study Status, Study Description, Contacts/Locations v20
Study title-34 characters
Pre-Exposure Prophylaxis Study to Assess Safety and Efficacy of Lenacapavir and Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection
2023-03-02
minor
Study Status v19
Re-verified, no change to tracked fields
2023-01-17
minor
Study Status, Contacts/Locations v18
2023-01-04
minor
Study Status v17
Re-verified, no change to tracked fields
2022-12-16
minor
Study Status, Contacts/Locations v16
2022-11-30
minor
Study Status, Contacts/Locations v15
2022-11-10
minor
Study Status v14
Re-verified, no change to tracked fields
2022-10-28
minor
Study Status, Contacts/Locations v13
2022-09-29
minor
Study Status, Contacts/Locations v12
Study sitesdetails revised at 1 of 19 sites
2022-09-07
minor
Study Status, Contacts/Locations v11
Study sitesdetails revised at 6 of 19 sites
2022-08-19
minor
Study Status, Contacts/Locations v10
2022-07-15
notable
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v9
Trial statusActive, Not Recruiting→Recruiting
Study sites10→14
2022-06-08
minor
Study Status, Eligibility v8
Re-verified, no change to tracked fields
2022-05-13
minor
Study Status, Contacts/Locations v7
2022-01-12
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v6
Trial statusRecruiting→Active, Not Recruiting
Completion date2027-06→2027-07
Study sitesdetails revised at 11 of 11 sites
2021-12-13
minor
Study Identification, Study Status v5
Re-verified, no change to tracked fields
2021-12-06
minor
Study Identification, Study Status, Contacts/Locations v4
2021-11-11
minor
Study Status, Contacts/Locations, References v3
2021-10-18
minor
Study Status, Contacts/Locations v2
2021-09-10
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-08→confirmed 2021-08-30
Study sites0→2