Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels
NCT05458102 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2024-12-03
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
- DRUG
-
Vesatolimod
Administered orally
- DRUG
-
Cobicistat
Administered orally
- DRUG
-
Voriconazole
Administered orally
- DRUG
-
Rifabutin
Administered orally
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Gilead Study Director · Gilead Sciences
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-19
- Primary Completion
- 2023-05-01
- Completion
- 2023-05-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study to Determine the Antiviral Activity of TMC310911 When Administered With Ritonavir in Treatment-Naive Human Immunodeficiency Virus - Type 1 (HIV-1) Infected Patients
NCT00838162 ·Status: COMPLETED ·Phase: PHASE2
-
SSAT067 PK of Atazanavir/Cobicistat and Darunavir/Cobicistat
NCT02589158 ·Status: COMPLETED ·Phase: PHASE1
-
Phase I Pharmacokinetic and Tolerance Study of Ribavirin in Human Immunodeficiency Virus (HIV) - Infected Patients
NCT00000733 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Understand the Effect of Itraconazole on the Levels of a Study Medicine Called ARV-471 in Healthy Adults
NCT05538312 ·Status: COMPLETED ·Phase: PHASE1
-
Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)
NCT00144170 ·Status: COMPLETED ·Phase: PHASE3
-
Drug Interactions Between Voriconazole and Atazanavir Coadministered as Atazanavir/Ritonavir in Healthy Participants
NCT00833482 ·Status: COMPLETED ·Phase: PHASE1
-
Combination Therapy With VRC01 and 10-1074 in HIV-Infected Individuals Undergoing Sequential Treatment Interruptions
NCT03831945 ·Status: TERMINATED ·Phase: PHASE1
-
A Bioequivalence Study of Darunavir, Emtricitabine, and Tenofovir Alafenamide, in the Presence of Cobicistat in Healthy Participants
NCT02578550 ·Status: COMPLETED ·Phase: PHASE1
-
Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/Ritonavir
NCT00120393 ·Status: COMPLETED ·Phase: PHASE3
-
A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat as Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared With Co-administration of the Separate Agents
NCT04661397 ·Status: COMPLETED ·Phase: PHASE1
-
Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients With Drug-resistant HIV
NCT00027339 ·Status: COMPLETED ·Phase: PHASE2
-
Safety of Lopinavir/Ritonavir (Kaletra) in HIV/HCV Co-infected Subjects vs Baseline Liver Biopsy Metavir Score
NCT00234975 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of Prevalence of the I50L Mutation When ATV Treated Patients Fail the Regimen
NCT00135447 ·Status: COMPLETED
-
Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone
NCT01605084 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Patients
NCT04592315 ·Status: COMPLETED ·Phase: PHASE1
-
Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy Subjects
NCT00357188 ·Status: COMPLETED ·Phase: PHASE1
-
Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir
NCT02104700 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Open Label Study of 908/RTV in Combination With Other PIs for the Treatment of Multi PI-Experienced HIV Subjects
NCT00144833 ·Status: TERMINATED ·Phase: PHASE3
-
Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults
NCT02951052 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.
NCT00435929 ·Status: COMPLETED ·Phase: PHASE1
-
Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir
NCT00458302 ·Status: COMPLETED ·Phase: PHASE3
-
Comparing Standard-Dose Versus Adjusted-Dose Lopinavir/Ritonavir Therapy in HIV-Infected Persons With Drug Resistance
NCT00046033 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Effectiveness of Lopinavir/Ritonavir in Individuals Who Have Failed Prior HIV Therapy
NCT00357552 ·Status: COMPLETED ·Phase: NA
-
Study Evaluating the Efficacy of a Reduced Dose Atazanavir in HIV-1-infected Patients
NCT02473328 ·Status: COMPLETED ·Phase: PHASE2
-
A Dose-Frequency Trial of Oral Retrovir in Patients With AIDS or Severe ARC
NCT00002046 ·Status: COMPLETED ·Phase: NA