HealthyPhase 1NCT02018510
A Phase 1, Open Label, Dose-escalation Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 3BNC117
A Phase 1 study testing 1 mg/kg, single dose IV administration of 3BNC117, 3 mg/kg, single dose IV administration of 3BNC117 and 10 mg/kg, single dose IV administration of 3BNC117 in people with Healthy and HIV, run by Rockefeller University at 4 sites in 2 countries.
Trial summary
The proposed study is a first-in-man phase I study that aims to evaluate the safety, tolerability and pharmacokinetics of 3BNC117 in HIV-infected and HIV-uninfected subjects, and its antiretroviral activity in HIV-infected subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- 1 mg/kg, single dose IV administration of 3BNC117, 3 mg/kg, single dose IV administration of 3BNC117 and 10 mg/kg, single dose IV administration of 3BNC117
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2014to Jan 2016
- 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
- Group 1 (HIV-uninfected):
- Adult males and females, age 18 to 65
- Amenable to HIV risk reduction counseling and agrees to maintaining behavior consistent with low risk of HIV exposure;
- If a sexually active male or female, participating in sexual activity that could lead to pregnancy, agrees to use an effective method of contraception throughout the study.
- Groups 2-5 (HIV-infected):
- Age 18 to 65
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- HIV infection confirmed by ELISA and immunoblot
- Groups 2A-D - on ART with HIV-1 plasma RNA levels below 100,000 copies/ml, or off ART for at least 8 weeks with HIV-1 plasma RNA level between 2,000-100,000 copies/ml by standard assays on 2 occasions at least 1 week apart;
- Group 2E - Untreated HIV-infected (not on ART for at least 8 weeks): HIV-1 RNA plasma levels between 2,000 - 100,000 copies/ml;
- Group 3 - Untreated HIV controllers (not on ART for at least 8 weeks): HIV-1 RNA plasma level of < 2,000 copies/ml by standard assays, on 2 occasions, at least 1 week apart, and ART-naive.
- Group 4 - ART treated with HIV-1 RNA plasma level of > 20 copies/ml by standard assays on 2 occasions, at least 1 week apart, while on combination antiretroviral therapy;
- Groups 5A and 5B - ART treated with HIV-1 RNA plasma level of < 20 copies/ml by standard assays on 2 occasions, at least 1 week apart, while on combination antiretroviral therapy;
- Current CD4 cell count > 300 cells/µl
- If sexually active male and female, participating in sexual activity that could lead to pregnancy, agrees to use an effective method of contraception throughout the study.
Who cannot join
- Group 1 (HIV-uninfected):
- Confirmed HIV-1 or HIV-2 infection;
- History of immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months;
- Any clinically significant acute or chronic medical condition that in the opinion of the investigator would preclude participation;
- Within the 12 months prior to enrollment, the volunteer has a history of sexually transmitted disease;
- Hepatitis B (surface antigen, HbsAg) or hepatitis C (HCV antibodies);
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- Laboratory abnormalities in the parameters listed below:
- Absolute neutrophil count ≤ 2,000
- Hemoglobin ≤ 12 gm/dL if female; ≤ 13.5 gm/dL if male
- Platelet count ≤ 140,000
- ALT ≥ 1.25 x ULN
- AST ≥ 1.25 x ULN
- Total bilirubin ≥ 1.1 ULN
- Creatinine ≥ 1.1 x ULN
- Coagulation parameters (PT, PTT, INR) ≥ 1.1 x ULN
- Pregnancy or breastfeeding;
- Any vaccination within 14 days prior to 3BNC117 administration;
- Receipt of any experimental HIV vaccine in the past or monoclonal antibody therapy of any kind in the past;
- Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.
- Groups 2-5 (HIV-infected):
- History of AIDS-defining illness
- History of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months;
- Any clinically significant acute or chronic medical condition, other than HIV infection, that in the opinion of the investigator would preclude participation;
- Hepatitis B (surface antigen, HbsAg) or hepatitis C (HCV antibodies);
- Laboratory abnormalities in the parameters listed below:
- Absolute neutrophil count ≤ 1,300
- Hemoglobin ≤ 10 gm/dL
- Platelet count ≤ 125,000
- ALT ≥ 2.0 x ULN
- AST ≥ 2.0 x ULN
- Total bilirubin ≥ 1.1 ULN
- Creatinine ≥ 1.1 x ULN
- Coagulation parameters ≥ 1.1 x ULN;
- Current antiretroviral regimen includes either maraviroc or enfuvirtide;
- Pregnancy or breastfeeding;
- Any vaccination within 14 days prior to 3BNC117 administration;
- Receipt of any experimental HIV vaccine or monoclonal antibody therapy of any kind in the past;
- Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
The Rockefeller University
New York, New York, 10065
Weill Cornell Medical Center
New York, New York, 10065
About this study
Official title: A Phase 1, Open Label, Dose-escalation Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 3BNC117 Monoclonal Antibody in HIV-infected and HIV-uninfected Volunteers
The proposed study is a first-in-man phase I study that aims to evaluate the safety, tolerability and pharmacokinetics of 3BNC117 in HIV-infected and HIV-uninfected subjects, and its antiretroviral activity in HIV-infected subjects.
Read the detailed description
In preclinical studies carried out in humanized mice and non-human primates, 3BNC117 alone or in combination with other neutralizing antibodies led to protection from HIV-1 or SHIV infection and also to sustained suppression of HIV-1 plasma viremia. The aims of this protocol are to evaluate the safety, tolerability and pharmacokinetics profile of 3BNC117 in both HIV-infected and HIV-uninfected subjects,and its antiretroviral activity in HIV-infected subjects.
- Being tested
- 1 mg/kg, single dose IV administration of 3BNC117, 3 mg/kg, single dose IV administration of 3BNC117, 10 mg/kg, single dose IV administration of 3BNC117, 30 mg/kg, single dose IV administration of 3BNC117, 10 mg/kg, two doses IV of 3BNC117
- Keywords
- Healthy Volunteers, HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 mg/kg, single dose IV administration of 3BNC117Biological
1 mg/kg, single dose IV administration of 3BNC117
3 mg/kg, single dose IV administration of 3BNC117Biological
3 mg/kg, single dose IV administration of 3BNC117
10 mg/kg, single dose IV administration of 3BNC117Biological
10 mg/kg, single dose IV administration of 3BNC117
30 mg/kg, single dose IV administration of 3BNC117Biological
30 mg/kg, single dose IV administration of 3BNC117
10 mg/kg, two doses IV of 3BNC117Biological
10 mg/kg, two IV administrations of 3BNC117 at weeks 0 and 12
30 mg/kg, two doses IV of 3BNC117Biological
30 mg/kg, two IV administrations of 3BNC117 at weeks 0 and 12
| Study group | Role | What they receive |
|---|---|---|
| Group 1A | Experimental | HIV-uninfected individuals
1 mg/kg, single dose IV administration of 3BNC117 Receives: Biological: 1 mg/kg, single dose IV administration of 3BNC117 |
| Groups 1B | Experimental | HIV-uninfected individuals 3 mg/kg, single dose IV administration of 3BNC117 Receives: Biological: 3 mg/kg, single dose IV administration of 3BNC117 |
| Group 1C | Experimental | HIV-uninfected individuals 10 mg/kg, single dose IV administration of 3BNC117 Receives: Biological: 10 mg/kg, single dose IV administration of 3BNC117 |
| Group 1D | Experimental | HIV-uninfected individuals 10 mg/kg, two doses IV of 3BNC117 Receives: Biological: 10 mg/kg, two doses IV of 3BNC117 |
| Group 1E | Experimental | HIV-uninfected individuals 30 mg/kg, single dose IV administration of 3BNC117 Receives: Biological: 30 mg/kg, single dose IV administration of 3BNC117 |
| Group 1F | Experimental | HIV-uninfected individuals 30 mg/kg, two doses IV of 3BNC117 Receives: Biological: 30 mg/kg, two doses IV of 3BNC117 |
| Group 2A | Experimental | HIV-infected individuals on or off ART
1 mg/kg, single dose IV administration of 3BNC117 Receives: Biological: 1 mg/kg, single dose IV administration of 3BNC117 |
| Group 2B | Experimental | HIV-infected individuals on or off ART 3 mg/kg, single dose IV administration of 3BNC117 Receives: Biological: 3 mg/kg, single dose IV administration of 3BNC117 |
| Group 2C | Experimental | HIV-infected individuals on or off ART 10 mg/kg, single dose IV administration of 3BNC117 Receives: Biological: 10 mg/kg, single dose IV administration of 3BNC117 |
| Group 2D | Experimental | HIV-infected individuals on or off ART 30 mg/kg, single dose IV administration of 3BNC117 Receives: Biological: 30 mg/kg, single dose IV administration of 3BNC117 |
| Group 2E | Experimental | HIV-infected individuals off ART, VL 2,000-100,000 copies/ml 30 mg/kg, single dose IV administration of 3BNC117 Receives: Biological: 30 mg/kg, single dose IV administration of 3BNC117 |
| Group 3 | Experimental | HIV-infected individuals off ART, VL < 2,000 copies/ml 30 mg/kg, single dose IV administration of 3BNC117 Receives: Biological: 30 mg/kg, single dose IV administration of 3BNC117 |
| Group 4 | Experimental | HIV-infected individuals on ART, VL < 100,000 copies/ml 30 mg/kg, single dose IV administration of 3BNC117 Receives: Biological: 30 mg/kg, single dose IV administration of 3BNC117 |
| Group 5A | Experimental | HIV-infected individuals on ART, VL < 20 copies/ml 10 mg/kg, single dose IV administration of 3BNC117 Receives: Biological: 10 mg/kg, single dose IV administration of 3BNC117 |
| Group 5B | Experimental | HIV-infected individuals on ART, VL < 20 copies/ml 30 mg/kg, single dose IV administration of 3BNC117 Receives: Biological: 30 mg/kg, single dose IV administration of 3BNC117 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
To evaluate the safety and tolerability profile of one or two intravenous infusions of 3BNC117 at 3 increasing dose levels in HIV-infected and HIV-uninfected individuals.
Measured: 24 weeks
Secondary outcomes (1)
Pharmacokinetic profile
To determine the pharmacokinetic profile of one or two intravenous infusions of 3BNC117 in HIV-uninfected and HIV-infected subjects.
Measured: 24 hours post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, Brigham and Women's Hospital, University of Cologne
- Responsible party
- Sponsor
- Investigators
- Marina Caskey, MD, Principal investigator, Rockefeller Univesrity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018510
- Sponsor's protocol ID
- MCA-0835
- Status last verified
- Dec 2016
- First submitted
- 17 Dec 2013
- Last updated
- 26 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Schoofs T, Klein F, Braunschweig M, Kreider EF, Feldmann A, Nogueira L, Oliveira T, Lorenzi JC, Parrish EH, Learn GH, West AP Jr, Bjorkman PJ, Schlesinger SJ, Seaman MS, Czartoski J, McElrath MJ, Pfeifer N, Hahn BH, Caskey M, Nussenzweig MC. HIV-1 therapy with monoclonal antibody 3BNC117 elicits host immune responses against HIV-1. Science. 2016 May 20;352(6288):997-1001. doi: 10.1126/science.aaf0972. Epub 2016 May 5.
PubMed 27199429
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Dose-escalation Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 3BNC117 Monoclonal Antibody in HIV-infected and HIV-uninfected Volunteers
- ClinicalTrials.gov ID
- NCT02018510
- Acronym / sponsor ID
- MCA-0835
- Keywords
- Healthy Volunteers, HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, Brigham and Women's Hospital, University of Cologne
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 23 Dec 2013 (estimated)
- 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.
The proposed study is a first-in-man phase I study that aims to evaluate the safety, tolerability and pharmacokinetics of 3BNC117 in HIV-infected and HIV-uninfected subjects, and its antiretroviral activity in HIV-infected subjects.
Detailed description
In preclinical studies carried out in humanized mice and non-human primates, 3BNC117 alone or in combination with other neutralizing antibodies led to protection from HIV-1 or SHIV infection and also to sustained suppression of HIV-1 plasma viremia. The aims of this protocol are to evaluate the safety, tolerability and pharmacokinetics profile of 3BNC117 in both HIV-infected and HIV-uninfected subjects,and its antiretroviral activity in HIV-infected subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Group 1A | Experimental | Biological: 1 mg/kg, single dose IV administration of 3BNC117HIV-uninfected individuals 1 mg/kg, single dose IV administration of 3BNC117 |
| Groups 1B | Experimental | Biological: 3 mg/kg, single dose IV administration of 3BNC117HIV-uninfected individuals 3 mg/kg, single dose IV administration of 3BNC117 |
| Group 1C | Experimental | Biological: 10 mg/kg, single dose IV administration of 3BNC117HIV-uninfected individuals 10 mg/kg, single dose IV administration of 3BNC117 |
| Group 1D | Experimental | Biological: 10 mg/kg, two doses IV of 3BNC117HIV-uninfected individuals 10 mg/kg, two doses IV of 3BNC117 |
| Group 1E | Experimental | Biological: 30 mg/kg, single dose IV administration of 3BNC117HIV-uninfected individuals 30 mg/kg, single dose IV administration of 3BNC117 |
| Group 1F | Experimental | Biological: 30 mg/kg, two doses IV of 3BNC117HIV-uninfected individuals 30 mg/kg, two doses IV of 3BNC117 |
| Group 2A | Experimental | Biological: 1 mg/kg, single dose IV administration of 3BNC117HIV-infected individuals on or off ART 1 mg/kg, single dose IV administration of 3BNC117 |
| Group 2B | Experimental | Biological: 3 mg/kg, single dose IV administration of 3BNC117HIV-infected individuals on or off ART 3 mg/kg, single dose IV administration of 3BNC117 |
| Group 2C | Experimental | Biological: 10 mg/kg, single dose IV administration of 3BNC117HIV-infected individuals on or off ART 10 mg/kg, single dose IV administration of 3BNC117 |
| Group 2D | Experimental | Biological: 30 mg/kg, single dose IV administration of 3BNC117HIV-infected individuals on or off ART 30 mg/kg, single dose IV administration of 3BNC117 |
| Group 2E | Experimental | Biological: 30 mg/kg, single dose IV administration of 3BNC117HIV-infected individuals off ART, VL 2,000-100,000 copies/ml 30 mg/kg, single dose IV administration of 3BNC117 |
| Group 3 | Experimental | Biological: 30 mg/kg, single dose IV administration of 3BNC117HIV-infected individuals off ART, VL < 2,000 copies/ml 30 mg/kg, single dose IV administration of 3BNC117 |
| Group 4 | Experimental | Biological: 30 mg/kg, single dose IV administration of 3BNC117HIV-infected individuals on ART, VL < 100,000 copies/ml 30 mg/kg, single dose IV administration of 3BNC117 |
| Group 5A | Experimental | Biological: 10 mg/kg, single dose IV administration of 3BNC117HIV-infected individuals on ART, VL < 20 copies/ml 10 mg/kg, single dose IV administration of 3BNC117 |
| Group 5B | Experimental | Biological: 30 mg/kg, single dose IV administration of 3BNC117HIV-infected individuals on ART, VL < 20 copies/ml 30 mg/kg, single dose IV administration of 3BNC117 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Group 1 (HIV-uninfected):
- Groups 2-5 (HIV-infected):
Key exclusion criteria (38 listed)
- Group 1 (HIV-uninfected):
- Groups 2-5 (HIV-infected):
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 |
|---|---|---|
| 1 mg/kg, single dose IV administration of 3BNC1171 mg/kg, single dose IV administration of 3BNC117 | Biological | Group 1A, Group 2A |
| 3 mg/kg, single dose IV administration of 3BNC1173 mg/kg, single dose IV administration of 3BNC117 | Biological | Group 2B, Groups 1B |
| 10 mg/kg, single dose IV administration of 3BNC11710 mg/kg, single dose IV administration of 3BNC117 | Biological | Group 1C, Group 2C, Group 5A |
| 30 mg/kg, single dose IV administration of 3BNC11730 mg/kg, single dose IV administration of 3BNC117 | Biological | Group 1E, Group 2D, Group 2E, Group 3, Group 4, Group 5B |
| 10 mg/kg, two doses IV of 3BNC11710 mg/kg, two IV administrations of 3BNC117 at weeks 0 and 12 | Biological | Group 1D |
| 30 mg/kg, two doses IV of 3BNC11730 mg/kg, two IV administrations of 3BNC117 at weeks 0 and 12 | Biological | Group 1F |
Primary outcome
Safety and tolerability
Time frame: 24 weeks
To evaluate the safety and tolerability profile of one or two intravenous infusions of 3BNC117 at 3 increasing dose levels in HIV-infected and HIV-uninfected individuals.
1 secondary outcome
Pharmacokinetic profile
Time frame: 24 hours post infusion
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 26 Dec 2016.
- Derived from this study: PubMed 27199429Schoofs T, Klein F, Braunschweig M, Kreider EF, Feldmann A, Nogueira L, Oliveira T, Lorenzi JC, Parrish EH, Learn GH, West AP Jr, Bjorkman PJ, Schlesinger SJ, Seaman MS, Czartoski J, McElrath MJ, Pfeifer N, Hahn BH, Caskey M, Nussenzweig MC. HIV-1 therapy with monoclonal antibody 3BNC117 elicits host immune responses against HIV-1. Science. 2016 May 20;352(6288):997-1001. doi: 10.1126/science.aaf0972. Epub 2016 May 5.
- 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.
Marina Caskey, MD principal investigator
Rockefeller Univesrity
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 1 mg/kg, single dose IV administration of 3BNC117, 3 mg/kg, single dose IV administration of 3BNC117 and 10 mg/kg, single dose IV administration of 3BNC117 in people with Healthy and HIV, run by Rockefeller University at 4 sites in 2 countries.
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 14 inclusion and 38 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 26 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany. 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?
Safety and tolerability (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02018510, which also lists 1 linked publication.
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 26 Dec 2016.