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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first dose date up to week 7 plus 30 days
Awards & highlights
Study Summary
This trial will study the effect of 3 drugs on vesatolimod, a drug used to treat HIV. The study will also evaluate the safety of this combination of drugs.
Eligible Conditions
- HIV
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first dose date up to week 7 plus 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first dose date up to week 7 plus 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PK Parameter : %AUCexp of VES
PK Parameter : AUCinf of VES
PK Parameter : CL/F of VES
+10 moreSide effects data
From 2016 Phase 2 trial • 162 Patients • NCT0216604720%
Headache
20%
Fatigue
7%
Chills
7%
Rhinitis
7%
Pyrexia
7%
Nausea
7%
Hot flush
7%
Diarrhoea
7%
Back pain
7%
Myalgia
7%
Pollakiuria
7%
Erectile dysfunction
7%
Nasal congestion
7%
Nail growth abnormal
7%
Hypertension
7%
Feeling hot
7%
Dizziness
7%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vesatolimod 2 mg 4 Weeks (Cohort A)
Vesatolimod 1 mg 8 Weeks (Cohort B)
Vesatolimod 2 mg 12 Weeks (Cohort C)
Vesatolimod 1 mg 12 Weeks (Cohort C)
Vesatolimod 4 mg 4 Weeks (Cohort A)
Vesatolimod 4 mg 8 Weeks (Cohort B)
Vesatolimod 1 mg 4 Weeks (Cohort A)
Placebo 4 Weeks (Cohort A)
Placebo 12 Weeks (Cohort C)
Vesatolimod 2 mg 8 Weeks (Cohort B)
Placebo 8 Weeks (Cohort B)
Vesatolimod 4 mg 12 Weeks (Cohort C)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Vesatolimod (VES) + Rifabutin (RFB)Experimental Treatment2 Interventions
Participants will receive:
In Period 1 (duration 1 day): participants will receive a single dose of VES 6 mg on Day 1
In Period 2 (duration 9 days): participants will receive RFB 300 mg once daily on Days 1 to 9; a single dose of VES 6 mg will be coadministered 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. Participants should inform the site of any AE during the washout period.
Group II: Vesatolimod (VES) + Cobicistat (COBI) + Voriconazole (VOR)Experimental Treatment3 Interventions
Participants will receive:
In Period 1 (duration 1 day): a single dose of VES 2 mg on Day 1
In Period 2 (duration 5 days): COBI 150 mg once daily on Days 1 to 5; a single dose of VES 2 mg will be coadministered on Day 2
In Period 3 (duration 6 days): a loading dose of VOR 400 mg twice daily on Day 1, then VOR 200 mg twice daily on Days 2 to 6; a single dose of VES 2 mg will be coadministered 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. Participants should inform the site of any adverse event (AE) during the washout period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Voriconazole
FDA approved
Rifabutin
FDA approved
Vesatolimod
Not yet FDA approved
Cobicistat
FDA approved
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,085 Previous Clinical Trials
848,127 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,557 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a high fever within the last 35 days before the start of the study.You have a serious heart condition or a family history of a certain heart syndrome that can cause abnormal heart rhythms.You are allergic to the study drugs or any ingredients in them.You have a medical condition where your immune system mistakenly attacks your own body.You have a serious skin condition like a rash, eczema, psoriasis, or hives.You are taking a specific combination of medications that include BIC, DTG, RAL, or DOR, along with Nucleoside Reverse Transcriptase Inhibitors (NRTIs). Examples of acceptable combinations include BIC/emtricitabine/tenofovir, DTG/ABC/3TC, DTG/3TC, DTG + emtricitabine/tenofovir, or DOR/3TC/tenofovir.To make the criterion more understandable, I need the specific conditions or events that should be mentioned in the criterion. Could you please provide the list of conditions or events that should be included?You have a strong sensitivity or allergy to certain medications that can cause severe reactions.You have experienced fainting, rapid or irregular heartbeats, or unexplained dizziness.You have a severe stomach ulcer that needs ongoing treatment for at least 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Vesatolimod (VES) + Cobicistat (COBI) + Voriconazole (VOR)
- Group 2: Vesatolimod (VES) + Rifabutin (RFB)
Awards:
This trial has 2 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
HIV Patient Testimony for trial: Trial Name: NCT05458102 — Phase 1
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