{"id":"nct:NCT04925752","kind":"trial","title":"Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People at Risk for HIV Infection","authors":["Gilead Sciences"],"author_count":1,"year":2021,"published":"2021-06-14","venue":"ClinicalTrials.gov","cited_by":null,"doi":null,"arxiv_id":null,"nct_id":"NCT04925752","source_url":"https://clinicaltrials.gov/study/NCT04925752","archive_url":"https://space-kitty.com/papers/nct:NCT04925752","updated":"2026-10-06","pmid":null,"pmcid":null,"openalex_id":null,"pdf_url":null,"abstract":"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 pre-exposure prophylaxis (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.","abstract_license":"ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters","license":"ClinicalTrials.gov terms (attribution, processing date, modifications noted)","is_open_access":true,"retracted":false,"peer_reviewed":null,"categories":["Pre-Exposure Prophylaxis of HIV Infection"],"details":{"acronym":"PURPOSE 2","status":"ACTIVE_NOT_RECRUITING","phase":"PHASE3","study_type":"INTERVENTIONAL","enrollment":3292,"sponsor":"Gilead Sciences","conditions":["Pre-Exposure Prophylaxis of HIV Infection"],"interventions":["DRUG: Oral Lenacapavir (LEN)","DRUG: F/TDF","DRUG: Sub-cutaneous (SC) Lenacapavir (LEN)","DRUG: Placebo SC LEN","DRUG: PTM F/TDF","DRUG: PTM Oral LEN","DRUG: F/TAF (for US participants only)"],"start_date":"2021-06-28","start_date_type":"ACTUAL","primary_completion_date":"2024-08-21","has_results":true,"data_source":"ClinicalTrials.gov","data_processed":"2026-10-29T09:00:05","modifications":"selected fields only; whitespace normalized; brief summary truncated to 2,000 characters"},"provenance":"clinicaltrials","attribution":"Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.","topics":[{"slug":"infectious-disease-amr","name":"Infectious Disease, Vaccines & Antimicrobial Resistance","domain_slug":"medicine"}],"cited_in_dossiers":[]}