The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE
Summary
The purpose of this study was to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA) antiretroviral therapy (ART) and all-oral standard of care (SOC).
Timeline
- Start
- 2019-03-28
- Primary completion
- 2024-02-12
- Completion
- 2026-08-17
Outcome
Met primary endpoint
registry analysis (superiority test); Step 2 Arm A: LA ART vs Step 2 Arm B: SOC; Cumulative probability difference -18.4 (98.4% CI -32.4 to -4.3) NCT03635788 ↗
release “LATITUDE phase III trial, indicating their long-acting injectable antiretroviral treatment (ART) for HIV, Cabenuva (cabotegravir + rilpivirine), demonstrated superior efficacy” gsk.com ↗
release “LATITUDE PHASE III INTERIM TRIAL DATA INDICATES ViiV HEALTHCARE’S LONG-ACTING INJECTABLE HIV TREATMENT CABENUVA (CABOTEGRAVIR + RILPIVIRINE) HAS SUPERIOR EFFICACY COMPARED TO DAILY THERAPY” shionogi.com ↗
release “Final data from LATITUDE study show switch to long-acting injectable treatment reduced the risk of virological failure by nearly half” viivhealthcare.com ↗
release “The cumulative risk of regimen failure through 48 weeks of treatment was reduced by nearly half in the study: 22.8% for those who were switched to long-acting injectable cabotegravir + rilpivirine vs. 41.2% for people continuing on daily oral therapy” viivhealthcare.com ↗
release “Findings build on the LATITUDE study, which demonstrated that CAB + RPV LA was superior to daily oral therapy” viivhealthcare.com ↗
Publications
- Rana AI, Zheng L, Castillo-Mancilla J, Bao Y, Sieczkarski S, Brooks KM, Lake JE, Fichtenbaum C, Heath SL, Belaunzaran-Zamudio PF, Klingman K, Fox L, Morton T, Stirratt M, Li JZ, Acosta EP, Venuto C, Galarraga O, Shoptaw S, Wohl D, Green M, Beijer C, Ferbas K, Jennings C, Shin K, Collahua R, Dorosh M, Wannamaker P, D'Amico R, Smith K, Spreen W, Vandermeulen K, Van Solingen-Ristea R, Wimbish C, Tashima KT, Landovitz RJ; ACTG A5359 LATITUDE Trial Team. Cabotegravir plus Rilpivirine for Persons with HIV and Adherence Challenges. N Engl J Med. 2026 Feb 26;394(9):858-871. doi: 10.1056/NEJMoa2508228. Epub 2026 Feb 18.
- Okesanya OJ, Ayeni RA, Amadin P, Ngwoke I, Amisu BO, Ukoaka BM, Ahmed MM, Oso TA, Musa SS, Lucero-Prisno DE. Advances in HIV Treatment and Vaccine Development: Emerging Therapies and Breakthrough Strategies for Long-Term Control. AIDS Res Treat. 2025 Jul 4;2025:6829446. doi: 10.1155/arat/6829446. eCollection 2025.
- Pluznik JA, Nijhawan AE, Spaulding AC. Does Anything Work? Improving HIV Care Engagement for Individuals Transitioning out of Correctional Settings. J Acquir Immune Defic Syndr. 2021 Mar 1;86(3):286-287. doi: 10.1097/QAI.0000000000002599. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabotegravir | Small molecule | 30 mg | Oral |
| Subject | Cabotegravir | Small molecule | 400 mg | Oral |
| Subject | Cabotegravir | Small molecule | 600 mg | Oral |
| Subject | Rilpivirine | Small molecule | 25 mg | Oral |
| Subject | Rilpivirine | Small molecule | 600 mg | Oral |
| Subject | Rilpivirine | Small molecule | 900 mg | Oral |