Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels
NCT ID: NCT05458102
Last Updated: 2024-12-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
18 participants
INTERVENTIONAL
2022-08-19
2023-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: Vesatolimod + Cobicistat + Voriconazole
Participants will receive a single dose of vesatolimod (VES) 2 mg on Day 1 of Period 1. In Period 2, participants will receive cobicistat (COBI) 150 mg once daily on Days 1 to 5 along with a single dose of VES 2 mg on Day 2. In Period 3, participants will receive a loading dose of voriconazole (VOR) 400 mg twice daily on Day 1, then VOR 200 mg twice daily on Days 2 to 6, and a single dose of VES 2 mg in the morning on Day 3. There will be a washout period of 7 to 14 days between treatments in Period 1 Day 1 and Period 2 Day 1 and a washout period of 14 to 21 days between treatments in Period 2 Day 5 and Period 3 Day 1.
Vesatolimod
Administered orally
Cobicistat
Administered orally
Voriconazole
Administered orally
Cohort 2: Vesatolimod + Rifabutin
Participants will receive a single dose of VES 6 mg on Day 1. In Period 2, participants will receive Rifabutin (RFB) 300 mg once daily on Days 1 to 9 along with a single dose of VES 6 mg on Day 6. There will be a washout period of 7 to 14 days between treatments in Period 1 Day 1 and Period 2 Day 1.
Vesatolimod
Administered orally
Rifabutin
Administered orally
Interventions
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Vesatolimod
Administered orally
Cobicistat
Administered orally
Voriconazole
Administered orally
Rifabutin
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cohort 1: A regimen of (bictegravir \[BIC\], dolutegravir \[DTG\], raltegravir \[RAL\], or doravirine \[DOR\]) plus Nucleoside Reverse Transcriptase Inhibitors (NRTIs). Examples of acceptable regimens include BIC/emtricitabine/tenofovir, DTG/ abacavir (ABC)/3TC, DTG/3TC, DTG + emtricitabine/tenofovir, or DOR/3TC/tenofovir
* Cohort 2: A DTG-based regimen is required (DTG/ABC/3TC), (DTG/3TC), or (DTG + NRTIs)
* Plasma HIV-1 RNA levels less than 50 copies/mL at screening
* Have normal hematologic function with an absolute neutrophil count greater than or equal to 1.5 × 10\^9/L, platelets greater than or equal to 150 × 10\^9/L; hemoglobin greater than or equal to 10.5 g/dL for females and greater than or equal to 11.5 g/dL for males
* Clusters of differentiation (CD) 4 T cell count greater than or equal to 350 cells/μL
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x upper limit of normal (ULN) and total bilirubin less than or equal to 1.5 mg/dL, or normal direct bilirubin and creatinine less than or equal to 1.25 x ULN
* 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
* Individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
* Must be willing and able to comply with all study requirements and available to complete the study schedule of assessments
* In the judgment of the investigator, be in good general health, based on review of the results from a screening visit
Exclusion Criteria
* Participation in any other clinical study (including observation studies) without prior approval from the sponsor is prohibited while participating in this study
* Have current alcohol or substance abuse judged by the investigator to potentially interfere with individual compliance or individual safety, or a positive drug or alcohol test at screening or baseline
* No Evidence of chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen \[HBsAg\] and/or positive HBV core antibody with positive reflex HBV DNA polymerase chain reaction (PCR)). Note: positive HBV core antibody with negative reflex HBV DNA PCR results are acceptable
* No Evidence of active hepatitis C virus (HCV) infection (defined as positive hepatitis C antibody and HCV RNA above lower limit of quantitation). Note: positive anti-HCV antibody and negative HCV PCR results are acceptable
* Acute febrile illness within 35 days prior to Day 1
* Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or is expected to receive these agents during the study
* Received any vaccine or immunomodulatory medication within 4 weeks prior to screening. Elective vaccination (eg, flu shot, hepatitis A or B vaccine) during the course of the study will require prior approval from the sponsor
* Coronavirus disease of 2019 (COVID-19) vaccinations are allowed, with the requirement that they should not be administered within 7 ± 2 days of receiving VES
* Have a history of any of the following:
* Significant serious skin disease, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria
* Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)
* Known hypersensitivity to the study drugs, their metabolites, or to formulation excipients
* Autoimmune disease
* Significant cardiac disease or a family history of long QT syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years
* Syncope, palpitations, or unexplained dizziness
* Implanted defibrillator or pacemaker
* Liver disease, including Gilbert syndrome
* Severe peptic ulcer disease requiring prolonged (≥ 6 months) medical treatment
* Medical or surgical treatment that permanently altered gastric absorption (eg, gastric or intestinal surgery). A history of cholecystectomy is not exclusionary
* Have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with individual treatment, assessment, or compliance with the protocol
* For Cohort 1, individuals with CYP2C19 genotype of CYP2C19\*2/\*2, CYP2C19\*2/\*3, or CYP2C19\*3/\*3
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Collaborative Neuroscience Research, LLC.
Long Beach, California, United States
Clinical Pharmacology of Miami, LLC.
Miami, Florida, United States
Advanced Pharma, CR, LLC.
Miami, Florida, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
Hassman Research Institute
Marlton, New Jersey, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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GS-US-382-1587
Identifier Type: -
Identifier Source: org_study_id