Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
NCT ID: NCT04994509
Last Updated: 2025-07-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
5368 participants
INTERVENTIONAL
2021-08-30
2028-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The primary objective of this study is to evaluate the efficacy of LEN and F/TAF for HIV-1 PrEP in AGYW at risk of HIV-1 infection.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women
NCT02652624
Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women
NCT01705574
A Study to Evaluate the Acceptability and Preference for Contraceptive Options as Proxy for HIV Prevention Methods
NCT02404038
Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study
NCT06274398
Ritonavir and Agenerase Treatment for Patients Who Have Failed Previous Anti-HIV Treatment
NCT00006591
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Randomized Blinded Phase: Lenacapavir
Participants will receive lenacapavir (LEN) 927 mg injection, every 26 weeks starting on Day 1 for up to approximately 52 weeks. Participants will also receive loading dose of LEN 600 mg, tablet, once daily on Day 1 and Day 2. Participants will receive placebo to match (PTM) emtricitabine/tenofovir disoproxil fumarate (F/TDF) or PTM emtricitabine/tenofovir alafenamide (F/TAF), once daily, up to approximately 52 weeks.
Oral Lenacapavir (LEN)
Tablets administered orally without regard to food
Subcutaneous (SC) Lenacapavir (LEN)
Administered via SC injections
PTM F/TAF
Tablets administered orally
PTM F/TDF
Tablets administered orally
Randomized Blinded Phase: F/TAF
Participants will receive F/TAF, once daily up to approximately 52 weeks. Participants will also receive PTM LEN injection, every 26 weeks, starting on Day 1 up to approximately 52 weeks. Participants will receive PTM LEN tablet, once daily on Day 1 and Day 2.
F/TAF
Tablets administered orally
Placebo SC LEN
Administered via SC injections
PTM Oral LEN
Tablets administered orally
Randomized Blinded Phase: F/TDF
Participants will receive F/TDF, once daily up to approximately 52 weeks. Participants will also receive PTM LEN injection, every 26 weeks starting on Day 1 up to approximately 52 weeks. Participants will receive PTM LEN tablet, once daily on Day 1 and Day 2.
F/TDF
Tablets administered orally
Placebo SC LEN
Administered via SC injections
PTM Oral LEN
Tablets administered orally
LEN Open-Label Extension (OLE) Phase
After completion of the Blinded phase, participants will be offered entry into the LEN OLE Phase.
Participants randomized to LEN will continue to receive LEN 927 mg injection, every 26 weeks until LEN becomes available or the sponsor elects to discontinue the study, whichever occurs first.
Participants randomized to F/TAF or F/TDF will receive LEN 927 mg injection on OLE Day 1, Week 26, and every 26 weeks thereafter. Participants will also receive LEN 600 mg tablet on OLE Days 1 and 2.
Oral Lenacapavir (LEN)
Tablets administered orally without regard to food
Subcutaneous (SC) Lenacapavir (LEN)
Administered via SC injections
Pharmacokinetic (PK) Tail Coverage Phase
Participants who prematurely discontinue study drug in the randomized blinded phase will transition into the PK Tail Coverage phase.
Participants will receive F/TDF, once daily, for 78 weeks beginning 26 weeks after the last LEN injection.
F/TDF
Tablets administered orally
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Oral Lenacapavir (LEN)
Tablets administered orally without regard to food
Subcutaneous (SC) Lenacapavir (LEN)
Administered via SC injections
F/TAF
Tablets administered orally
F/TDF
Tablets administered orally
Placebo SC LEN
Administered via SC injections
PTM Oral LEN
Tablets administered orally
PTM F/TAF
Tablets administered orally
PTM F/TDF
Tablets administered orally
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* HIV-1 status unknown at initial screening and no prior human immunodeficiency 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.
Exclusion Criteria
* Prior use of any long-acting systemic HIV pre-exposure prophylaxis (PrEP) or prior HIV postexposure prophylaxis (PEP) in the past 12 weeks.
16 Years
25 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gilead Sciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Madibeng Centre for Research
Brits, , South Africa
Emavundleni Research Centre
Cape Town, , South Africa
Vuka Research Clinic
Cape Town, , South Africa
Desmond Tutu Health Foundation Clinical Trials Unit
Cape Town, , South Africa
Botha's Hill Clinical Research Site, HIV Prevention Research Unit
Durban, , South Africa
CAPRISA eThekwini Clinical Research Site
Durban, , South Africa
CAPRISA Vulindlela Clinical Research Site
Durban, , South Africa
MatCH Research Unit, Suite 1112, 11th Floor
Durban, , South Africa
Synergy Biomed Research Institute (SBRI)
East London, , South Africa
Setshaba Research Centre
Gauteng, , South Africa
Wits Reproductive Health & HIV Institute (Wits RHI)
Johannesburg, , South Africa
The Aurum Institute: Gavin J Churchyard Legacy Centre, Klerksdorp Clinical Research Centre
Klerksdorp, , South Africa
Perinatal HIV Research Unit (PHRU) Soweto Kliptown
Kliptown, , South Africa
Phoenix Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
Kwa Zulu Natal, , South Africa
Verulam Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
Kwa Zulu Natal, , South Africa
Tongaat Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
Kwa Zulu Natal, , South Africa
Chatsworth Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit
Kwa Zulu Natal, , South Africa
Qhakaza Mbokodo Research Clinic
Ladysmith, , South Africa
Africa Health Research Institute
Mtubatuba, , South Africa
The Aurum Institute: Pretoria Clinical Research Centre
Pretoria, , South Africa
The Aurum Institute: Rustenburg Clinical Research Centre
Rustenburg, , South Africa
Desmond Tutu Health Foundation - Masiphumelele Research Office
Sunnydale, , South Africa
The Aurum Institute: Tembisa Clinical Research Centre
Tembisa, , South Africa
CAPRISA Umlazi Clinical Research Site
Umlazi, , South Africa
FPD-DTHF Ndevana Community Research Site
Vincent, , South Africa
Makerere-Kalangala Clinical Research site
Kalangala, , Uganda
AMBSO Masaka Clinical Research site
Kyotera- Masaka Region, , Uganda
Makerere University- John Hopkins University (MU-JHU) Mityana Research Site (MU-JHU) Care Ltd
Mityana Town, , Uganda
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bekker LG, Das M, Abdool Karim Q, Ahmed K, Batting J, Brumskine W, Gill K, Harkoo I, Jaggernath M, Kigozi G, Kiwanuka N, Kotze P, Lebina L, Louw CE, Malahleha M, Manentsa M, Mansoor LE, Moodley D, Naicker V, Naidoo L, Naidoo M, Nair G, Ndlovu N, Palanee-Phillips T, Panchia R, Pillay S, Potloane D, Selepe P, Singh N, Singh Y, Spooner E, Ward AM, Zwane Z, Ebrahimi R, Zhao Y, Kintu A, Deaton C, Carter CC, Baeten JM, Matovu Kiweewa F; PURPOSE 1 Study Team. Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women. N Engl J Med. 2024 Oct 3;391(13):1179-1192. doi: 10.1056/NEJMoa2407001. Epub 2024 Jul 24.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Gilead Clinical Trials Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DOH-27- 072021-6125
Identifier Type: REGISTRY
Identifier Source: secondary_id
GS-US-412-5624
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.