Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels

Phase 1 Terminated 18 enrolled Gilead Sciences

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical study is to learn more about the impact of cobicistat (COBI) (P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and strong cytochrome P450 enzyme \[CYP\]3A inhibitor), voriconazole (VOR) (strong CYP3A inhibitor), and rifabutin (RFB) (moderate CYP3A inducer) on the study drug, vesatolimod (VES), in people with HIV-1 on antiretroviral therapy (ART).

Timeline

Start: 2022-08-19
Primary completion: 2023-05-01
Completion: 2023-05-01

Outcome

Outcome not reported

Stopped: “Sponsor's decision to change the clinical development plan of this molecule. This decision is not based on efficacy or safety concerns.”

Publications

Zheng Y, Wire M, Omange RW, deVries CR, Zhang L, Chen B, Huang SSY, Cruz K, Hassman H, Osiyemi O, Rondon JC, Lim D, West S, Wen A, Wallin JJ, SenGupta D, Cai Y. The Effects of Cobicistat and Voriconazole on the Safety, Pharmacokinetics, and Pharmacodynamics of the TLR7 Agonist Vesatolimod in People with HIV. Infect Dis Ther. 2025 Nov;14(11):2535-2549. doi: 10.1007/s40121-025-01227-x. Epub 2025 Sep 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cobicistat	Small molecule	150 mg	Oral
Subject	Rifabutin	Small molecule	300 mg	Oral
Subject	Vesatolimod	Small molecule	2 mg	Oral
Subject	Vesatolimod	Small molecule	6 mg	Oral
Subject	Voriconazole	Small molecule	200 mg	Oral