HIVPhase 1NCT03063788
Imaging the HIV Reservoir
A Phase 1 study testing 3BNC117-Copper-64 in people with HIV, run by Bayside Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- 3BNC117-Copper-64
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Sep 2018to 1 Apr 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HIV
- Being tested
- 3BNC117-Copper-64
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3BNC117-Copper-64Drug
3 mg/kg 3BNC117 combined with radio-isotope Copper-64
| Study group | Role | What they receive |
|---|---|---|
| HIV uninfected | Experimental | A single intravenous infusion of 3mg/kg 3BNC117 combined with Copper-64 to 2 HIV uninfected individuals Receives: 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 Receives: 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 Receives: Drug: 3BNC117-Copper-64 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 days
Secondary outcomes (2)
Safety and tolerability (adverse events and assessment of laboratory parameters)
Reporting of adverse events and assessment of laboratory parameters
Measured: 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
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start18 Sep 2018
- Primary completion1 Feb 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- The Peter Doherty Institute for Infection and Immunity, Monash University, Monash Health, Rockefeller University, Austin Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063788
- Sponsor's protocol ID
- 568/16
- Status last verified
- Sep 2018
- First submitted
- 21 Feb 2017
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging the HIV Reservoir
- ClinicalTrials.gov ID
- NCT03063788
- Acronym / sponsor ID
- 568/16
- Conditions
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- The Peter Doherty Institute for Infection and Immunity, Monash University, Monash Health, Rockefeller University, Austin Health
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV uninfected | Experimental | Drug: 3BNC117-Copper-64A single intravenous infusion of 3mg/kg 3BNC117 combined with Copper-64 to 2 HIV uninfected individuals |
| HIV infected viremic | Experimental | Drug: 3BNC117-Copper-64A 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 | Experimental | Drug: 3BNC117-Copper-64A 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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 :
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3BNC117-Copper-643 mg/kg 3BNC117 combined with radio-isotope Copper-64 | Drug | HIV infected aviremic, HIV infected viremic, HIV uninfected |
Primary outcome
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)
Time frame: 2 days
To determine if there is increased PET uptake in HIV viremic and aviremic groups as compared to uninfected group
2 secondary outcomes
Safety and tolerability (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.
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 3BNC117-Copper-64 in people with HIV, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020.