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Immunomodulator

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

Phase 1

Waitlist Available

Research Sponsored by Gilead Sciences

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 predose up to 96 hours postdose

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing how three different drugs affect the levels of vesatolimod in people with HIV-1 who are already on antiretroviral therapy. The goal is to understand if these drugs make vesatolimod more or less effective.

Eligible Conditions

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose up to 96 hours postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose up to 96 hours postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 96 hours postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PK Parameter : %AUCexp of VES

PK Parameter : AUCinf of VES

PK Parameter : CL/F of VES

+8 more

Side effects data

From 2016 Phase 2 trial • 162 Patients • NCT02166047

20%

Headache

20%

Fatigue

Chills

Rhinitis

Pyrexia

Nausea

Hot flush

Diarrhoea

Back pain

Myalgia

Pollakiuria

Erectile dysfunction

Nasal congestion

Nail growth abnormal

Hypertension

Feeling hot

Dizziness

Dysgeusia

100%

80%

60%

40%

20%

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)

Awards & Highlights

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.

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

Rifabutin

FDA approved

Vesatolimod

Not yet FDA approved

Cobicistat

FDA approved

Voriconazole

FDA approved