Imaging the HIV Reservoir

Phase 1

Completed

• Conditions: HIV
• Interventions: Drug: 3BNC117-Copper-64

• Registration Number: NCT03063788
• Lead Sponsor: Bayside Health

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-23
• Study First Posted: 2017-02-24
• Status Verified: 2018-09
• Study Start: 2018-09-18
• Primary Completion: 2020-02-01
• Study Completion: 2020-04-01
• Last Update Submitted: 2020-06-22
• Last Update Posted: 2020-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HIV uninfected	3BNC117-Copper-64	A single intravenous infusion of 3mg/kg 3BNC117 combined with Copper-64 to 2 HIV uninfected individuals
HIV infected viremic	3BNC117-Copper-64	A single intravenous infusion of 3mg/kg 3BNC117 combined with Copper-64 to 4 HIV infected individuals with viremia who are not receiving antiretroviral therapy
HIV infected aviremic	3BNC117-Copper-64	A single intravenous infusion of 3mg/kg 3BNC117 combined with Copper-64 to 4 HIV infected individuals with undetectable HIV viral load who are receiving antiretroviral therapy

Primary Outcome Measures

Name	Time	Method
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)	2 days	To determine if there is increased PET uptake in HIV viremic and aviremic groups as compared to uninfected group

Secondary Outcome Measures

Name	Time	Method
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.	2 days	To determine whether HIV positive participants display organ specific binding of the anti-HIV antibody
Safety and tolerability (adverse events and assessment of laboratory parameters)	2 weeks	Reporting of adverse events and assessment of laboratory parameters

Trial Locations

Locations (1)

Alfred Health; 🇦🇺 Melbourne, Victoria, Australia