NCT03468582

123I Radiolabeled 3BNC117

Completed EARLY_PHASE1 Last updated 29 January 2020

What this trial tests

EARLY_PHASE1 trial testing 123I radiolabeled 3BNC117 in Human Immunodeficiency Virus in 6 participants. Completed in 28 January 2020.

Timeline

8 February 2018

Primary endpoint
28 January 2020

28 January 2020

Quick facts

Lead sponsor	University of Lausanne Hospitals
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	6
Start date	8 February 2018
Primary completion	28 January 2020
Estimated completion	28 January 2020
Sites	1 location across Switzerland

Drugs / interventions tested

• 123I radiolabeled 3BNC117

Conditions studied

• Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →

Sponsor

University of Lausanne Hospitals

Who can join

Adults 18 to 55, any sex, with Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The conventional way to control HIV infection is the usage of a drug cocktail capable of suppressing the viral replication cycle, commonly known as antiretroviral therapy (ART). Despite effective ART it is not possible to eradicate HIV. The virus hides in particular cells to form the latent HIV-reservoir.\[1-9\] Studies that emphasise on revealing hidden reservoirs would aid in designing novel therapeutic strategies for controlling HIV infection. Molecular imaging by SPECT/CT has the potential to reveal hidden reservoirs of HIV virus that are not eliminated by currently used drugs capable of suppressing and thereby controlling the viral replication cycle in HIV infected patients. New approaches, necessary to prevent and treat HIV-1 infection, are gradually emerging. A new generation of highly potent broadly neutralizing antibodies (bN/Abs) may represent a promising approach to combating HIV-1 infection.\[10\] The broadly neutralizing antibody 3BNC117 antibody that can mimic human CD4 binding targeted against the HIV gp120 envelope protein has been tested in various clinical trials.\[11-14\] It has found to be safe and effective in reducing viraemia and to improve host humoral responses in HIV-1 infected individuals, and to have effect on viral rebound in patients who are kept off antiretroviral treatment briefly for experimental purpose.

Imaging of simian immunodeficiency virus (SIV) infection by PET/CT has been successfully performed in nonhuman primates with a 64Cu-labeled SIV gp120-specific antibody called 7D3.\[15\] This study aims to use a similar approach in human with the 3BNC117 antibody. The 3BNC117 antibody has been successfully radiolabeled with iodine 123. The half-life of this radioisotope is appropriate for antibody imaging in nuclear medicine. Radiolabeled 123I 3BNC117 was shown to keep a good immunoreactivity for gp120. By using state of the art SPECT scanner a semi-quantitative image will be obtained. In addition, the absence of any chelator and the well known use of iodine-123 in clinic make it suitable for human intervention.

No HIV imaging in human has been achieved yet, which is however fundamental to understand some key steps in the pathogenesis of HIV-induced immunodeficiency. This research opens promising opportunities for drug and vaccine development. Indeed, identification of virus reservoirs in treated patients would facilitate the development of strategies for eradicating these reservoirs or for extending latency period.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical trials of broadly neutralizing monoclonal antibodies in people living with HIV - a review.
   Mahomed S, Pillay K, Hassan-Moosa R, Galvão BPGV, et al · · 2025 · cited 20× · PMID 40189566 · DOI 10.1186/s12981-025-00734-8
2. Immunotherapy with Cell-Based Biological Drugs to Cure HIV-1 Infection.
   Siracusano G, Lopalco L. · · 2021 · cited 1× · PMID 35011639 · DOI 10.3390/cells11010077