38 completed, 13 recruiting, 12 active not recruiting, 6 not yet recruiting. 24 Phase 1, 18 Phase 3, 12 Phase 2, 8 Phase 4, 2 Not applicable.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings Cabotegravir Injection, Cabotegravir Pill, Buprenorphine injection - HIV Infections, Opioid Use Disorder | Phase 4 | Not yet recruiting | Duke University | 450 | 2026-09-01 | 2026-08-26 |
| Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy Lenacapavir, Lenacapavir Tablet, Teropavimab - HIV Infections | Phase 3 | Recruiting | Gilead Sciences | 590 | 2026-07-14 | 2026-08-14 |
| Cabotegravir-Hormone PK/PD Interactions for HIV Prevention Cabotegravir Injectable Suspension (CAB LA) - HIV, Prophylaxis | Phase 1 | Recruiting | Johns Hopkins University | 32 | 2026-07-07 | 2026-07-13 |
| PERsistance of Long-Acting inJEctable CAB+RPV in a Cohort of Virologically-suppressed PLWH: a Real-life Study Cabotegravir/Rilpivirine - HIV-1-infection | Not yet recruiting | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | 200 | 2026-06-01 | 2026-05-12 | |
| Optimization of Antiretroviral Therapy in Patients With AIDS-Related Lymphoma Oral Antiretroviral Therapy, albuvirtide, Cabotegravir/Rilpivirine - AIDS-related Lymphoma, HIV Infection | Not applicable | Recruiting | Shanghai Public Health Clinical Center | 60 | 2026-05-26 | 2026-07-27 |
| Long-Acting Cabotegravir and Rilpivirine in People Living With HIV-1 Subtype A6: A Real-World Retrospective Study Cabotegravir Plus Rilpivirine Long-Acting Injectable - Human Immunodeficiency Virus (HIV)-1 Infection, HIV-1 Subtype A6 Infection | Recruiting | Pomeranian Medical University Szczecin | 250 | 2026-05-12 | 2026-06-11 | |
| A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1 Oral CAB, IM CAB LA - HIV Infections | Phase 1 / Phase 2 | Recruiting | ViiV Healthcare | 44 | 2026-04-15 | 2026-05-19 |
| Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention Lenacapavir Injection, Emtricitabine/tenofovir disoproxil fumarate (F/TDF), Emtricitabine/tenofovir alafenamide (F/TAF) - HIV Infections | Recruiting | Gilead Sciences | 3000 | 2026-03-17 | 2026-10-21 | |
| Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs APRETUDE (cabotegravir) - HIV, Substance Use Disorder (SUD) | Phase 4 | Recruiting | Massachusetts General Hospital | 100 | 2026-02-24 | 2026-03-19 |
| ALIGN: A Non-randomised Study Delivering Injectable Lenacapavir for HIV Prevention Within a Pre-exposure Prophylaxis (PrEP) Choice Context in Cape Town, South Africa. Lenacapavir Injection, Cabotegravir (CAB) LA, Tenofovi-Emtricitabine (TDF/FTC) tablet - HIV | Not yet recruiting | Desmond Tutu HIV Foundation | 3700 | 2026-01-29 | 2026-02-05 | |
| A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV Cabotegravir long-acting, Lenacapavir long-acting - HIV Infections | Phase 1 | Active not recruiting | ViiV Healthcare | 65 | 2025-04-22 | 2025-11-28 |
| Long-acting Injectable Antiretroviral Treatment to Improve HIV Treatment Among Justice-involved Persons Being Released to the Community The first FDA-approved LAI ART regimen includes an integrase inhibitor, cabotegravir (CAB), and a non-nucleoside reverse transcriptase inhibitor, rilpivirine (RPV) combined 4 wks - HIV | Not yet recruiting | The Miriam Hospital | 20 | 2025-02-01 | 2025-01-15 | |
| Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs Collaborative drug therapy management model, Cabotegravir/Rilpivirine - Hiv | Phase 2 | Active not recruiting | Yale University | 50 | 2024-08-01 | 2026-10-13 |
| Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals cabotegravir/rilpivirine (600mg/ 900mg), Antiretroviral Combinations - HIV-1-infection, Non-Adherence, Medication | Phase 3 | Active not recruiting | Chang Gung Memorial Hospital | 40 | 2024-07-19 | 2026-10-26 |
| Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus) CAB LA - HIV Infections | Phase 3 | Active not recruiting | ViiV Healthcare | 2996 | 2024-05-14 | 2026-07-30 |
| Impact of Long-acting Injectable Cabotegravir for HIV PrEP in MSM in France. Cabotegravir Tablets, for oral use., Cabotegravir Extended-Release Injectable Suspension, for intramuscular use., Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral use - Prevention | Phase 3 | Not yet recruiting | ANRS, Emerging Infectious Diseases | 322 | 2024-04-01 | 2024-02-23 |
| Implementing Oral (Event-driven and Daily) and Long-acting Pre-Exposure Prophylaxis in Mobile Men in Sub-Saharan Africa Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC), cabotegravir (CAB-LA), Cabotegravir (CAB-LA), Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC) - HIV | Phase 3 | Not yet recruiting | MRC/UVRI and LSHTM Uganda Research Unit | 400 | 2024-04-01 | 2023-11-15 |
| Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT APRETUDE (cabotegravir) 600 mg\3 mL, DAPIRING (Dapivirine) 25mg Vaginal Ring, tenofovir disoproxil and emtricitabine - HIV Infections | Phase 3 | Recruiting | Africa Health Research Institute | 2052 | 2024-02-27 | 2026-07-09 |
| PrEPared to Choose (PtC) is an Implementation Study of the Delivery of Cabotegravir Long-acting, an Injectable Pre-exposure Prophylaxis (PrEP) Option for HIV Prevention. Injectable PrEP Will be Offered Alongside Oral and Vaginal Ring PrEP From Within a Real-world Context in Cape Town, South Africa. Cabotegravir long-acting, Tenofovir emtricitabine, Dapivirine containing vaginal ring - HIV Infection, Sexual and Reproductive Health | Recruiting | Desmond Tutu HIV Foundation | 1800 | 2024-02-13 | 2025-02-04 | |
| Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP Cabotegravir Injection [Apretude] - Hiv | Active not recruiting | Midway Specialty Care Center | 100 | 2024-01-02 | 2025-11-03 |
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HIV Infections (43) · Acquired Immunodeficiency Syndrome (25) · Infections (17) · Hepatitis (2) · Substance-Related Disorders (2) · Breast Feeding (1) · Coitus (1) · HIV-Associated Lipodystrophy Syndrome (1) · Injection Site Reaction (1) · Lymphoma, AIDS-Related (1) · Medication Adherence (1) · Opioid-Related Disorders (1) · Psychological Well-Being (1) · Renal Insufficiency (1) · Sexually Transmitted Diseases (1)
ViiV Healthcare (32) · National Institute of Allergy and Infectious Diseases (NIAID) (8) · Desmond Tutu HIV Foundation (2) · Gilead Sciences (2) · GlaxoSmithKline (2) · MRC/UVRI and LSHTM Uganda Research Unit (2) · ANRS, Emerging Infectious Diseases (1) · Africa Health Research Institute (1) · Beth Israel Deaconess Medical Center (1) · Castagna Antonella (1) · Centre for the AIDS Programme of Research in South Africa (1) · Chang Gung Memorial Hospital (1) · Duke University (1) · Emory University (1) · Evandro Chagas National Institute of Infectious Disease (1)
United States (48) · South Africa (16) · Spain (8) · Canada (7) · Germany (7) · Italy (7) · Argentina (6) · France (6) · Uganda (6) · Kenya (5) · Australia (4) · Botswana (4) · Brazil (4) · Puerto Rico (4) · United Kingdom (4)
Lynda Stranix-Chibanda, MBChB, MMED (2) · Raphael J. Landovitz, MD, MSc (2) · Sybil Hosek, PhD (2) · Aadia Rana, M.D. (1) · Aditya H. Gaur, MD (1) · Babafemi Taiwo, MBBS (1) · Beatriz Grinsztejn, MD, PhD (1) · Carolyn Bolton Moore, MSc, MBBCh (1) · Christopher B Fox, MSN (1) · Curt G Beckwith, MD (1) · Diane Havlir, MD (1) · Edith Apondi (1)
PMID 35508986, PMID 37452174, PMID 39052748, PMID 40655875, PMID 32497490, PMID 33136751, PMID 34648734, PMID 37776478, PMID 23979733, PMID 26201299, PMID 28750935, PMID 30230694, PMID 30408115, PMID 32130809, PMID 32361755, PMID 32497491, PMID 33560746, PMID 33794181, PMID 34056699, PMID 34261093, PMID 34379922, PMID 34652287, PMID 34656207, PMID 34978890, PMID 35378077, PMID 35986671, PMID 37074775, PMID 37265259, PMID 37783219, PMID 37952550, PMID 38427337, PMID 38538160, PMID 38538161, PMID 38709006, PMID 38783534, PMID 39311597, PMID 39395424, PMID 39446416, PMID 39676239, PMID 40049924, PMID 40088909, PMID 40216420, PMID 40267471, PMID 40296638, PMID 40383512, PMID 40590452, PMID 40600468, PMID 40600480, PMID 40698814, PMID 40779489
2016 (2), 2017 (2), 2023 (1), 2025 (1), R01AI155052 (1), R01AI186440 (1), R01HD108047 (1), R01MH123724 (1), R34DA057165 (1), R61DA060583 (1), U01AI150510 (1)