drugset / Trial / NCT03635788
The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE
Phase 3
Active not recruiting
456 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
ViiV Healthcare · collab
RandomizedParallel-groupOpen-labelTreatment
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
- 2026-08-30
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 |