Radiolabelling broadly neutralizing anti-HIV antibody 3BNC117 with a Copper-64 radio isotope for infusion into people with HIV followed by MRI/PET scanning to detect HIV in vivo.
This study aims to develop a method to accurately image the size and location of HIV persistence in HIV-infected individuals. The project aims to combine the broadly neutralizing anti-HIV antibody 3BNC117 with a Copper-64 radio isotope for use in a clinical trial. The clinical trial has three different stages. The first stage is to recruit two HIV uninfected individuals and determine the safety of 3 mg/kg of 3BNC117 combined with Copper-64 and MRI/PET scanning at 1, 24 and 48 hours post infusion. The second stage is to examine the distribution on MRI/PET of the 3BNC117-Copper-64 combination in four HIV-infected individuals with viremia who are not receiving antiretroviral therapy. The final stage is to perform the same intervention in aviremic people with HIV receiving antiretroviral therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
17
3 mg/kg 3BNC117 combined with radio-isotope Copper-64
Alfred Health
Melbourne, Victoria, Australia
Comparisons of PET standard uptake values in regions of interest (gastrointestinal tract, lymph node groups, genital tract, and spleen) between the three groups (uninfected, viremic and aviremic infected)
To determine if there is increased PET uptake in HIV viremic and aviremic groups as compared to uninfected group
Time frame: 2 days
Safety and tolerability (adverse events and assessment of laboratory parameters)
Reporting of adverse events and assessment of laboratory parameters
Time frame: 2 weeks
Comparisons of PET standard uptake values in regions of interest within each individual to radioactivity levels in a homogenous area of muscle to generate target to muscle ratios.
To determine whether HIV positive participants display organ specific binding of the anti-HIV antibody
Time frame: 2 days
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