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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03063788




Registration number
NCT03063788
Ethics application status
Date submitted
21/02/2017
Date registered
24/02/2017

Titles & IDs
Public title
Imaging the HIV Reservoir
Scientific title
Imaging the HIV Reservoir
Secondary ID [1] 0 0
568/16
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 3BNC117-Copper-64

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

Experimental: HIV infected viremic - 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

Experimental: HIV infected aviremic - 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


Treatment: Drugs: 3BNC117-Copper-64
3 mg/kg 3BNC117 combined with radio-isotope Copper-64
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
2 days
Secondary outcome [1] 0 0
Safety and tolerability (adverse events and assessment of laboratory parameters)
Timepoint [1] 0 0
2 weeks
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
2 days

Eligibility
Key inclusion criteria
Inclusion Criteria for All Groups:

* 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 specific Inclusion criteria:

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)

* Documented HIV-1 infection
* Not on ART for at least 8 weeks with HIV RNA plasma levels between 2,000 - 100,000 copies/ml
* Current CD4+ T cell counts >300 cells/µL
* 3BNC117 sensitivity of subject derived HIV

Group 3 (HIV infected aviremic on ART)

* Documented HIV-1 infection
* Receiving combination ART for at least 12 months
* HIV-1 plasma RNA <50 copies/mL for > 12 months and <20 copies/mL at screening. Episodes of a single HIV plasma RNA 50-500 copies/mL will not exclude participation if the subsequent HIV plasma RNA was <50 copies/mL
* Current CD4+ T cell counts >300 cells/µL
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria for All Groups:

* 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
* Women who are pregnant or breastfeeding or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy as specified in the inclusion criteria
* 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2020
Sample size
Target
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Peter Doherty Institute for Infection and Immunity
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Monash Health
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Rockefeller University
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Government body
Name [5] 0 0
Austin Health
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03063788