NCT05458102

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

A Phase 1, Open-label, Multicohort Study to Evaluate the Impact of Inhibitors and Inducers of Cytochrome P450 Enzyme (CYP)3A and/or P-glycoprotein (P-gp) on the Pharmacokinetics (PK) of Vesatolimod (VES) in Virologically Suppressed Adults With HIV-1 on Antiretroviral Therapy (ART)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Interventions

Type	Name	Description
DRUG	Vesatolimod	Administered orally
DRUG	Cobicistat	Administered orally
DRUG	Voriconazole	Administered orally
DRUG	Rifabutin	Administered orally

Timeline

• Start date: 2022-08-19
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2022-07-14
• Last updated: 2024-12-03
• Results posted: 2024-12-03

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study