A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed

Summary

This study is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA compared with maintenance of BIK. BIKTARVY is a registered trademark of Gilead Sciences.

Timeline

Start

2020-11-09

Primary completion

2022-07-13

Completion

2023-04-17

Publications

• Background Karver TS, Pascual-Bernaldez M, Berni A, Hnoosh A, Castagna A, Messiaen P, Puerto MJG, Bloch M, Adachi E, Sinclair G, Felizarta F, Angel JB, Sutton K, Sutherland-Phillips D, D'Amico R, Kerrigan D. Factors Associated with Health Care Providers' Preference for Forgoing an Oral Lead-In Phase When Initiating Long-Acting Injectable Cabotegravir and Rilpivirine in the SOLAR Clinical Trial. AIDS Patient Care STDS. 2023 Jan;37(1):53-59. doi: 10.1089/apc.2022.0168.
• Background Ramgopal MN, Castagna A, Cazanave C, Diaz-Brito V, Dretler R, Oka S, Osiyemi O, Walmsley S, Sims J, Di Perri G, Sutton K, Sutherland-Phillips D, Berni A, Latham CL, Zhang F, D'Amico R, Pascual Bernaldez M, Van Solingen-Ristea R, Van Eygen V, Patel P, Chounta V, Spreen WR, Garges HP, Smith K, van Wyk J. Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results (SOLAR): a randomised, open-label, phase 3b, non-inferiority trial. Lancet HIV. 2023 Sep;10(9):e566-e577. doi: 10.1016/S2352-3018(23)00136-4. Epub 2023 Aug 8.
• Adachi E, Yokomaku Y, Watanabe D, Gatanaga H, Oka S, Shirasaka T, D'Amico R, Sutton K, Sutherland-Phillips D, Roberts J, Thornhill J, Murungi A, Brown K. Month 12 outcomes of switching to long-acting cabotegravir + rilpivirine with an oral lead-in versus continuing bictegravir/emtricitabine/tenofovir alafenamide in the Phase 3b randomized SOLAR study. J Infect Chemother. 2025 Dec;31(12):102834. doi: 10.1016/j.jiac.2025.102834. Epub 2025 Oct 17.
• Adachi E, Yokomaku Y, Watanabe D, Gatanaga H, Oka S, Shirasaka T, Wakatabe R, Chamay N, Sutton K, Sutherland-Phillips D, Urbaityte R, D'Amico R, van Wyk J. Efficacy and safety of switching to long-acting cabotegravir + rilpivirine versus continuing bictegravir/emtricitabine/tenofovir alafenamide in Japanese participants: 12-month results from the phase 3b randomized SOLAR trial. J Infect Chemother. 2025 Jul;31(7):102734. doi: 10.1016/j.jiac.2025.102734. Epub 2025 May 16.
• Tan DHS, Antinori A, Eu B, Galindo Puerto MJ, Kinder C, Sweet D, Van Dam CN, Sutton K, Sutherland-Phillips D, Berni A, Zhang F, Urbaityte R, Baugh B, Spreen W, van Wyk J, Garges HP, Patel P, Batterham R, D'Amico R. Weight and Metabolic Changes With Long-Acting Cabotegravir and Rilpivirine or Bictegravir/Emtricitabine/Tenofovir Alafenamide. J Acquir Immune Defic Syndr. 2025 Apr 1;98(4):401-409. doi: 10.1097/QAI.0000000000003584. Epub 2025 Feb 19.

Drugs

Indications