Imaging the HIV Reservoir

NCT03063788 | Completed Phase 1

• 1 other identifier: 568/16
• Study Type: interventional
• Actual enrollment (reported): 17
• Locations: 1 country
• Sites: 1
• Actual (reported): Study Start
• Actual (reported): Primary Completion
• Actual (reported): Study Completion

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• 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

  2 days

Secondary Outcomes (2)

• Safety and tolerability (adverse events and assessment of laboratory parameters)

  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.

  2 days

Study Arms (3)

HIV uninfected

EXPERIMENTAL

A single intravenous infusion of 3mg/kg 3BNC117 combined with Copper-64 to 2 HIV uninfected individuals

Drug: 3BNC117-Copper-64

HIV infected viremic

EXPERIMENTAL

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

Drug: 3BNC117-Copper-64

HIV infected aviremic

EXPERIMENTAL

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

Drug: 3BNC117-Copper-64

Interventions

3BNC117-Copper-64 DRUG

3 mg/kg 3BNC117 combined with radio-isotope Copper-64

HIV infected aviremic; HIV infected viremic; HIV uninfected

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 65 years
• Able to give informed consent
• A female, may be eligible to participate if she:
• Is of non-child-bearing potential defined as either post-menopausal or incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,
• Is of child-bearing potential with a negative pregnancy test at screening and agrees to use one of the following methods of contraception consistently and for at least 8 weeks after receiving the investigational drug :
• Complete abstinence from 2 weeks prior to investigational drug, and for at least 8 weeks after receiving the investigational drug
• Double barrier method
• Any intrauterine device (IUD) with published data showing that the expected failure rate is \<1% per year
• Male partner sterilization confirmed prior to the female subject's entry into the study, and this male is the sole partner for that subject
• Approved hormonal contraception
• Any other method with published data showing that the expected failure rate is \<1% per year
• Group 1 (HIV-uninfected)
• A negative HIV Ag/Ab test at screening
• Amenable to HIV risk reduction counselling and agrees to maintain behaviour consistent with low risk of HIV exposure
• Group 2 (HIV infected viremic off ART)

You may not qualify if:

• Any clinically significant acute or chronic medical condition that in the opinion of the investigator would preclude participation (e.g. lymphoproliferative disorders or significant resections of the gastrointestinal tract that would interfere with the distribution of HIV tissue reservoirs)
• Receipt of a vaccination 14 days prior to receiving investigational drug
• Previous use of histone deacetylase inhibitors or other latency reversing agents
• Receipt of experimental HIV vaccine or monoclonal antibody therapy of any kind in the past
• History of Hepatitis B (Positive HBsAg) or Hepatitis C co-infection (Individuals with prior hepatitis C infection that is now cleared are eligible for enrolment)
• Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification
• Active alcohol or substance use that in the opinion of the investigator will prevent adequate compliance with study procedures
• Currently pregnant, breastfeeding or unwilling to use barrier contraception
• The following laboratory abnormalities:
• Absolute neutrophil count ≤1,300
• Hemoglobin ≤ 10 gm/dL
• Platelet count ≤125,000
• ALT ≥ 2.0 x ULN
• Total bilirubin ≥ 1.5 ULN
• Creatinine ≥ 1.1 x ULN

Sponsors & Collaborators

• Bayside Health: lead
• The Peter Doherty Institute for Infection and Immunity: collaborator
• Monash University: collaborator
• Monash Health: collaborator
• Rockefeller University: collaborator
• Austin Health: collaborator

Study Sites (1)

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Enrollment

17 participants — actual enrollment reported by the registry.

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 24, 2017
• Last Updated: June 24, 2020

Study Start

September 18, 2018

Actual (reported)

Primary Completion

February 1, 2020

Actual (reported)

Study Completion

April 1, 2020

Actual (reported)

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)