Vesatolimod for Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Advanced Pharma, CR, LLC., Miami, FL
Human Immunodeficiency Virus Type 1 (HIV-1) Infection+2 More
Vesatolimod - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The primary objectives of this study are to evaluate 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 vesatolimod (VES) pharmacokinetics (PK) and to evaluate safety in virologically suppressed adults with HIV-1 on antiretroviral therapy (ART).

Eligible Conditions

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Study Objectives

13 Primary · 0 Secondary · Reporting Duration: First dose date up to Week 7 plus 30 days

Week 7
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormalities
Hour 96
PK Parameter : %AUCexp of VES
PK Parameter : AUCinf of VES
PK Parameter : CL/F of VES
PK Parameter : Clast of VES
PK Parameter : Cmax of VES
PK Parameter : Lambda z of VES
PK Parameter : Tlast of VES
PK Parameter : Tmax of VES
PK Parameter : Vz/F of VES
PK Parameter : t1/2 of VES
Pharmacokinetic (PK) Parameter : AUClast of Vesatolimod (VES)

Trial Safety

Safety Progress

1 of 3

Other trials for Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Trial Design

2 Treatment Groups

Vesatolimod (VES) + Cobicistat (COBI) + Voriconazole (VOR)
1 of 2
Vesatolimod (VES) + Rifabutin (RFB)
1 of 2
Experimental Treatment

45 Total Participants · 2 Treatment Groups

Primary Treatment: Vesatolimod · No Placebo Group · Phase 1

Vesatolimod (VES) + Cobicistat (COBI) + Voriconazole (VOR)Experimental Group · 3 Interventions: Cobicistat, Voriconazole, Vesatolimod · Intervention Types: Drug, Drug, Drug
Vesatolimod (VES) + Rifabutin (RFB)Experimental Group · 2 Interventions: Vesatolimod, Rifabutin · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cobicistat
2014
Completed Phase 2
~530
Voriconazole
2008
Completed Phase 4
~5740
Vesatolimod
2014
Completed Phase 2
~430
Rifabutin
2003
Completed Phase 4
~860

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: first dose date up to week 7 plus 30 days
Closest Location: Advanced Pharma, CR, LLC. · Miami, FL
Photo of Miami 1Photo of Miami 2Photo of Miami 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Human Immunodeficiency Virus Type 1 (HIV-1) Infection
0 CompletedClinical Trials

Who is running the clinical trial?

Gilead SciencesLead Sponsor
999 Previous Clinical Trials
657,459 Total Patients Enrolled
64 Trials studying Human Immunodeficiency Virus Type 1 (HIV-1) Infection
16,151 Patients Enrolled for Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Gilead Study DirectorStudy DirectorGilead Sciences
314 Previous Clinical Trials
176,617 Total Patients Enrolled
35 Trials studying Human Immunodeficiency Virus Type 1 (HIV-1) Infection
9,471 Patients Enrolled for Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Plasma HIV-1 RNA levels less than 50 copies/mL at screening.
You have normal hematologic function with an absolute neutrophil count greater than or equal to 1.
You have a CD4 T cell count greater than or equal to 350 cells/μL.
AST and ALT less than or equal to 2.5 x ULN and total bilirubin less than or equal to 1.
You have a calculated creatinine clearance (CLcr) of at least 60 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at screening and upon admission.
You are of childbearing potential and are assigned female at birth.
You must be willing and able to comply with all study requirements and available to complete the study schedule of assessments.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.