5 completed, 1 active not recruiting, 1 not yet recruiting, 1 recruiting. 8 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 8 | Completed 5, Active not recruiting 1, Not yet recruiting 1, Recruiting 1 |
Follow cabotegravir: new trials by email Literature Review of cabotegravir trials Research Report on cabotegravir
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 | 2026-12-01 | 2026-11-06 |
| 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 |
| Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana Cabotegravir Injection [Apretude] - Pre-Exposure Prophylaxis (PrEP), Breast Feeding | Phase 4 | Active not recruiting | Beth Israel Deaconess Medical Center | 500 | 2023-11-30 | 2026-07-30 |
| Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administration, Out of Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administration - HIV-1 Infection | Phase 4 | Completed | Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | 103 | 2023-09-26 | 2025-07-14 |
| SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension Cabotegravir Injectable Suspension, Dynamic Choice Delivery Model, Standard of Care - HIV | Phase 4 | Completed | University of California, San Francisco | 984 | 2023-01-02 | 2026-09-24 |
| A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories APRETUDE, Cabotegravir tablet - HIV Infections | Phase 4 | Completed | ViiV Healthcare | 295 | 2022-10-28 | 2026-10-01 |
| A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States APRETUDE, Cabotegravir OLI - HIV Infections | Phase 4 | Completed | ViiV Healthcare | 287 | 2022-05-18 | 2025-12-15 |
| Parrying the Pitfalls of PrEP: Project PEACH PrEP discontinuation intervention, Offering of on-demand oral PrEP, Offering of STI PEP - HIV, STI | Phase 4 | Completed | Emory University | 240 | 2021-11-20 | 2026-04-01 |
HIV Infections (3) · Breast Feeding (1) · Opioid-Related Disorders (1) · Sexually Transmitted Diseases (1) · Substance-Related Disorders (1)
ViiV Healthcare (2) · Beth Israel Deaconess Medical Center (1) · Duke University (1) · Emory University (1) · Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia (1) · Massachusetts General Hospital (1) · University of California, San Francisco (1)
United States (6) · Botswana (1) · Kenya (1) · Spain (1) · Uganda (1)
Diane Havlir, MD (1) · Lauren Brinkley-Rubinstein, PhD (1) · Maya Petersen, MD, PhD (1) · Moses Kamya, MBChB, PhD (1) · Patrick Sullivan, MD (1) · Rebecca Zash, MD (1)
PMID 39395424, PMID 40216420, PMID 40267471, PMID 40600480, PMID 41762058, PMID 42437832
R01HD108047 (1), R01MH123724 (1), R61DA060583 (1), U01AI150510 (1)