Imaging Immune Activation in HIV by PET-MR

Status Recruiting

Clinical Trial Summary

This is a single center exploratory imaging study involving one intravenous microdose of [18F]F-AraG followed by whole-body positron emission tomography-magnetic resonance (PET-MR) imaging in HIV infected individuals to determine the anatomical distribution of the PET tracer. Participants will be enrolled if they were treated during early or late HIV infection. In addition, individuals not on antiretroviral therapy (ART) or with HIV-1 plasma RNA levels >5,000 copies/mL will be enrolled.

Clinical Trial Description

The PET radiofluorinated imaging agent, [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine; trade name VisAcT) localizes to sites of immune activation and is predominantly accumulated in proliferative T cells. As a result, there is interest in imaging residual immune activation in the setting of both treated and untreated HIV-1 infection, a disease in which chronic immune activation and inflammation may lead to significant morbidity, despite the use of otherwise suppressive ART.

The primary endpoint is to determine the anatomical distribution of [18F]F-AraG in HIV-infected individuals taking or not taking antiretroviral therapy.

Secondary objectives are to determine if [18F]F-AraG PET-MRI is able to detect differences in T cell activation between patients with early versus late treated HIV infection and to determine if [18F]F-AraG uptake correlates with direct blood and tissue measures of HIV reservoir size and activity in the above cohorts/studies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03684655
Study type	Interventional
Source	University of California, San Francisco
Contact	Timothy J Henrich, MD
Phone	415-206-5518
Email	timothy.henrich@ucsf.edu
Status	Recruiting
Phase	Phase 1
Start date	September 21, 2018
Completion date	June 1, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03067285` - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study	Phase 4
Completed	`NCT03141918` - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS	N/A
Active, not recruiting	`NCT03256422` - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients	Phase 3
Recruiting	`NCT03256435` - PrEP Intervention for African American MSM in Mississippi	N/A
Completed	`NCT00517803` - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies	N/A
Recruiting	`NCT03572335` - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Enrolling by invitation	`NCT03275571` - HIV, Computerized Depression Therapy & Cognition	N/A
Completed	`NCT02234882` - Study on Pharmacokinetics	Phase 1
Recruiting	`NCT03669133` - Vitamin E for NASH Treatment in HIV Infected Individuals	Phase 2
Completed	`NCT02116660` - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)	Phase 2
Recruiting	`NCT03701802` - Immunogenetic Modulators of Mucosal Protection From HIV-1
Recruiting	`NCT03271307` - Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners	N/A
Recruiting	`NCT03485963` - HIV-1 Specific T -Cells (HST-NEETs) for HIV-Infected Individuals	Phase 1
Recruiting	`NCT03577782` - Vedolizumab Treatment in HIV-Infected Subjects Without Previous Antiretroviral Therapy	Phase 1/Phase 2
Not yet recruiting	`NCT03682939` - Evaluation of Safety and Immunogenicity of Meningococcal B and Meningococcal ACWY Vaccine in at Risk Population	Phase 4
Active, not recruiting	`NCT01852942` - Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV	Phase 2
Active, not recruiting	`NCT01937455` - A Phase 1, Randomized, Blinded, Dose-escalation Study of rAAV1-PG9DP Recombinant AAV Vector Coding for PG9 Antibody in Healthy Male Adults.	Phase 1
Withdrawn	`NCT01975012` - Safety, Tolerability, Drug Interactions, and Antiviral Activity of Rilpivirine in Antiretroviral-Naive HIV-Infected Children Less Than 12 Years of Age	Phase 1/Phase 2
Active, not recruiting	`NCT01931358` - Study of Boosting Strategies After Vaccination With ALVAC-HIV and AIDSVAX® B/E	Phase 2
Completed	`NCT01968551` - Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults	Phase 3