Imaging Immune Activation in HIV Infection

Who is this study for? Patients with Human Immunodeficiency Virus
What treatments are being studied? [18F]F-AraG (2'-deoxy-2'-fluoro-9-?-D-arabinofuranosylguanine)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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. Up to 30 participants will be enrolled with HIV.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>18 years

• Ability to read and understand written informed consent document

• HIV infection, and Initiated a combination ART regimen, or, has never received ART, or, has received ART in the past, but has not been taking for a least 1 week prior to study imaging.

• (Of note, per Department of Health and Human Services (DHHS) guidelines, the protocol team will strongly recommend that all HIV+ participants initiate ART who not done so already, both for their own health and to prevent the transmission of HIV infection.)

• Laboratory evaluations obtained within 60 days prior to entry. i. Platelet count ≥100,000/mm3 ii. ANC \>1500/mm3 iii. Aspartate aminotransferase (AST) \<2 x ULN iv. Alanine aminotransferase (ALT) \<2 x ULN v. CD4+ T cell count \>100 cells/mm3 for HIV infected individuals vi. Calculated creatinine clearance (CrCl) ≥60 mL/min as estimated by the Cockcroft-Gault equation: For men, (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dL x 72) = CrCl (mL/min)\*

⁃ For women, multiply the result by 0.85 = CrCl (mL/min)

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Timothy J Henrich, MD
timothy.henrich@ucsf.edu
415-206-5518
Time Frame
Start Date: 2018-09-21
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 30
Treatments
Experimental: [18F]F-AraG
radiofluorinated imaging agent, \[18F\]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine)~Trade name: VisAcT
Authors
Benajamin Franc
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), University of California, San Francisco
Leads: CellSight Technologies, Inc.

This content was sourced from clinicaltrials.gov