This is a single-center drug distribution and pharmacokinetic study of a single microdose of 18F-raltegravir given to 10 HIV-infected subjects who are either taking or not taking a raltegravir-containing ART regimen. After administration of IV 18F-raltegravir, subjects will undergo PET/MRI in order to determine the distribution of radiolabeled drug through the lymphoreticular system and other tissues throughout the entire body.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
A single microdose of 18F-Raltegravir will be given to individuals currently being treated for HIV-1 with antiretroviral therapy.
University of California, San Francisco
San Francisco, California, United States
RECRUITINGNumber of patients with microdose (<2.5 millicurie; mCi) 18F-Raltegravir-related adverse events as measured by clinical observation during single intravenous dose administration and PET/MR imaging
Time frame: One imaging session within 1 to 6 hours following administration of 18F-Raltegravir
Whole-body distribution (coronal through pelvis) of radiolabeled 18F-Raltegravir as determined by PET-MR scanning and quantification of radiographic regions of interest (ROI) immediately following and up to 4 hours after drug administration.
Time frame: One imaging session within 1 to 6 hours following administration of 18F-Raltegravir
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