Study of VRC07-523LS, CAP256V2LS, and Vesatolimod, in Early Antiretroviral-treated HIV-1 Clade C-infected Women

Summary

The goals of this clinical study are to learn more about the study drugs, VRC07-523LS, CAP256V2LS, and vesatolimod (VES) and how safe it is in women that have HIV and are on antiretroviral therapy (ART).

Timeline

Start

2022-06-09

Primary completion

2025-01-16

Completion

2025-01-16

Publications

• Background Dong K, Asari V, Govender V, et al. Evaluation of 2 bNAbs plus vesatolimod in early-treated South African women with HIV-1 during ATI [CROI abstract 105]. Top Antivir Med. 2025;33:14
• Background Omange RW, Zhang L, Reddy K, et al. Presence of protective human leukocyte antigen class I and II is associated with improved analytical treatment interruption outcomes in a trial of vesatolimod and broadly neutralizing antibodies in South African women with early-treated clade C HIV-1. Presented at the Keystone HIV Cure: Antiretroviral Therapy-Free Control of HIV Infection Symposium; April 7-10, 2025; Durban, South Africa. Poster 2014.
• Background Dong K, SenGupta D, Gama L, et al. First HIV cure interventional trial in Africa with collaboration between academia, government, and industry. Presented at the 13th International AIDS Society (IAS) Conference on HIV Science; July 13-17, 2025; Kigali, Rwanda. ePoster EP1003.
• Background Cai Y, Zhang L, Omange RW, et al. Vesatolimod pharmacodynamic responses in a trial of vesatolimod and broadly neutralizing antibodies in early-treated South African women with clade C HIV-1. Presented at the 13th International AIDS Society (IAS) Conference on HIV Science; July 13-17, 2025; Kigali, Rwanda. Poster WEPEB018.
• Ahmed A, Hill M, Dong KL, Ngcobo MW, Zulu A, Langa N, Maphalala L, Pillay V, Mthembu M, Tran W, Lau R, Stockman JK, Ndung'u T, Dube K. Stress and Coping During an HIV Cure-Related Trial with an Analytical Treatment Interruption: A Qualitative Assessment of the Experiences of Young Women in Durban, South Africa. J Int Assoc Provid AIDS Care. 2026 Jan-Dec;25:23259582261423985. doi: 10.1177/23259582261423985. Epub 2026 Feb 13.
• Ahmed A, Dong KL, Hussain M, Ngcobo MW, Langa N, Zulu A, Maphalala L, Pillay V, Mthembu M, Wan F, Tran W, Lau R, Stockman JK, Ndung'u T, Dube K. Psychological Impact of Analytical Treatment Interruption on Young Women Enrolled in an HIV Cure-Related Clinical Trial in Durban, South Africa. AIDS Res Hum Retroviruses. 2026 Mar;42(3):109-116. doi: 10.1177/08892229251405807. Epub 2026 Jan 2.

Drugs

Indications