Human Immunodeficiency VirusPhase 1NCT04250636

3BNC117-LS and 10-1074-LS in Viremic HIV-infected Individuals

A Phase 1 study testing 3BNC117-LS and 10-1074-LS in people with Human Immunodeficiency Virus, run by Rockefeller University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The proposed study is a phase 1, open label, single arm study to evaluate the safety, pharmacokinetics and antiviral activity of single intravenous infusions of 3BNC117-LS and 10-1074-LS, each monoclonal antibody (mAb) dosed at 30 mg/kg in viremic human immunodeficiency virus (HIV)-infected individuals. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Human Immunodeficiency Virus
What is being tested?: 3BNC117-LS and 10-1074-LS
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 3 sitesUnited States
Study dates: 13 Oct 2020to 11 Feb 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females, >18 years of age.
Confirmed HIV-1 infection.
Off ART for at least 4 weeks with a HIV-1 plasma RNA level between 500 and 100,000 copies/mL (ART-naïve or off ART due to intolerance or by choice).
Current CD4+ T cell count > 300 cells/μl.
If sexually active male or female, and participating in sexual activity that could lead to pregnancy or transmission of HIV, agrees to use two effective methods of contraception (i.e. condom with spermicide, diaphragm with spermicide, hormone-eluting IUD, hormone-based contraceptive with condom) from 10 days prior to and six months after 3BNC117-LS and 10-1074-LS administration.

Who cannot join

Have a history of AIDS-defining illness within 3 years prior to enrollment.
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 (such as autoimmune diseases), other than HIV infection, that in the opinion of the investigator would preclude participation.
Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg) or hepatitis C virus RNA (HCV-RNA) in blood.
Laboratory abnormalities in the parameters listed below:
Absolute neutrophil count ≤ 1,000 cells/μl;

Show all 19Show fewer

Hemoglobin ≤ 10 gm/dL;
Platelet count ≤ 100,000 cells/μl;
ALT ≥ 1.5 x ULN;
AST ≥ 1.5 x ULN;
Alkaline phosphatase ≥ 1.5 x ULN;
Total bilirubin > 1.25 x ULN;
eGFR < 60 mL/min/1.73m2.
Pregnancy or lactation.
Any vaccination within 14 days prior to mAb infusions, except for influenza vaccine.
Receipt of another investigational product currently or within the past 12 weeks, or expected concurrent participation in another study in which investigational products will be administered.
Receipt of any experimental HIV vaccine or anti-HIV monoclonal antibody therapy in the past.
History of severe reaction to a vaccine or drug infusion or history of severe allergic reactions.
Individuals with known hypersensitivity to any constituent of the investigational products.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Weill Cornell Medical Center Clinical Trials Unit-CLOSED SITE
New York, New York, 10021
The Rockefeller University
New York, New York, 10065
Perelman School of Medicine University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: An Open Label, Single Arm Study of the Safety, Pharmacokinetics and Antiretroviral Activity of the Combination of 3BNC117-LS and 10-1074-LS in Viremic HIV-infected Individuals.

Read the detailed description

Ten eligible participants will be enrolled sequentially in the study and will receive each mAb, dosed at 30 mg/kg intravenously and in sequence on study day 0. Following mAb administration, study participants will return for safety assessments on days 1 and 3, and weeks 1, 2, 3 and 4 following dosing, then bi-weekly or monthly until the end of study follow up. All participants will be followed for 24 weeks after 3BNC117-LS and 10-1074-LS administration.

Safety assessments will be performed at multiple time points following 3BNC117-LS and 10-1074-LS infusions. Serum samples for pharmacokinetic (PK) measurements will be collected before and at the end each mAb infusion administration and at multiple subsequent time points during study follow up. Samples will also be collected for measurement of HIV-1 plasma RNA levels before 3BNC117-LS and 10-1074-LS infusions (screen and day 0) and at every follow up visit. T cell subsets will also be monitored during study follow up. Assessments will also include measurement of anti-drug antibody responses and sequencing of plasma envelope before infusions and after viral rebound (first time point after viremia nadir is reached and viral load (VL) is > 1,000 copies/ml).

Participants will be advised and encouraged to start antiretroviral therapy (ART) within 4 weeks of receiving 3BNC117-LS and 10-1074-LS infusions or sooner if: VL fails to decrease by > 0.5 log10 copies/ml within 2 weeks of antibody infusions, VL increases > 0.5 log10 copies/ml between weekly measurements or significant T-cell decline (confirmed CD4+ T cells < 200 cells/μl) is noted.

Conditions: Human Immunodeficiency Virus
Being tested: 3BNC117-LS, 10-1074-LS
Keywords: 3BNC117-LS, 10-1074-LS, Broadly Neutralizing Antibody
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3BNC117-LSDrug
Also called Monoclonal Antibody
Intravenous infusion of 3BNC117-LS at 30mg/kg
10-1074-LSDrug
Also called Monoclonal Antibody
Intravenous infusion of 10-1074-LS at 30mg/kg

Study groups in NCT04250636
Study group	Role	What they receive
Study Participants	Experimental	HIV-infected individuals, off ART, and with plasma HIV-1 RNA levels between 500 and 100,000 copies/ml by standard assays. Study participants will receive a single intravenous infusion of 3BNC117-LS and a single infusion of 10-1074-LS. The antibodies will be administered sequentially and dosed at 30 mg/kg. Receives: Drug: 3BNC117-LS; Drug: 10-1074-LS

What is being measured

The primary outcome is the main question the study is designed to answer.

Grade 3 and Serious Adverse Events
The number of participants with treatment-related solicited and unsolicited grade 3 and serious adverse events (including confirmed laboratory abnormalities).
Measured: 24 weeks
Peak Concentration
Peak concentration of 3BNC117-LS and 10-1074-LS when administered intravenously and in combination to viremic HIV-infected individuals.
Measured: 24 weeks
Half-life
Half-life of 3BNC117-LS and 10-1074-LS when administered intravenously and in combination to viremic HIV-infected individuals.
Measured: 24 weeks
Area Under Curve
Area under curve of 3BNC117-LS and 10-1074-LS when administered intravenously and in combination to viremic HIV-infected individuals.
Measured: 24 weeks
Maximum Decline in Plasma HIV-1 RNA Level
Maximum decline in plasma HIV-1 RNA level after 3BNC117-LS plus 10-1074-LS intravenous infusions in viremic HIV-infected individuals through week 4 after infusions.
Measured: 4 weeks

Secondary outcomes (3)

Anti-drug Antibodies
Number of individuals with treatment-induced anti-drug antibodies against each mAb and magnitude of the response.
Measured: 24 weeks
Adverse Events
The number of adverse events that occur during the study follow up period after 3BNC117-LS and 10-1074-LS administration.
Measured: 24 weeks
Laboratory Abnormalities
The number of confirmed laboratory abnormalities that occur during the study follow up period after 3BNC117-LS and 10-1074-LS administration.
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Oct 202011 Feb 2022

First posted31 Jan 2020
Study start13 Oct 2020
Primary completion21 Jan 2022
Study completion11 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Human Immunodeficiency VirusStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04250636
Sponsor's protocol ID: MCA-0994
Other IDs: 1U01AI145921
Status last verified: Jun 2023
First submitted: 30 Jan 2020
Last updated: 26 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Single Arm Study of the Safety, Pharmacokinetics and Antiretroviral Activity of the Combination of 3BNC117-LS and 10-1074-LS in Viremic HIV-infected Individuals.
ClinicalTrials.gov ID: NCT04250636
Acronym / sponsor ID: MCA-0994
Conditions: Human Immunodeficiency Virus
Keywords: 3BNC117-LS, 10-1074-LS, Broadly Neutralizing Antibody
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Rockefeller UniversityUniversity, hospital or other
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Weill Medical College of Cornell University, University of Pennsylvania
Study start: 13 Oct 2020 (actual)
Primary completion: 21 Jan 2022 (actual)
Study completion: 11 Feb 2022 (actual)
First posted: 31 Jan 2020 (actual)
Results: Posted 26 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study Participants	Experimental	Drug: 3BNC117-LS, Drug: 10-1074-LSHIV-infected individuals, off ART, and with plasma HIV-1 RNA levels between 500 and 100,000 copies/ml by standard assays. Study participants will receive a single intravenous infusion of 3BNC117-LS and a single infusion of 10-1074-LS. The antibodies will be administered sequentially and dosed at 30 mg/kg.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Males and females, >18 years of age.
Confirmed HIV-1 infection.
Off ART for at least 4 weeks with a HIV-1 plasma RNA level between 500 and 100,000 copies/mL (ART-naïve or off ART due to intolerance or by choice).
Current CD4+ T cell count > 300 cells/μl.
If sexually active male or female, and participating in sexual activity that could lead to pregnancy or transmission of HIV, agrees to use two effective methods of contraception (i.e. condom with spermicide, diaphragm with spermicide, hormone-eluting IUD, hormone-based contraceptive with condom) from 10 days prior to and six months after 3BNC117-LS and 10-1074-LS administration.

Key exclusion criteria (19 listed)

Have a history of AIDS-defining illness within 3 years prior to enrollment.
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 (such as autoimmune diseases), other than HIV infection, that in the opinion of the investigator would preclude participation.
Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg) or hepatitis C virus RNA (HCV-RNA) in blood.
Laboratory abnormalities in the parameters listed below:

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-LSAlso: Monoclonal AntibodyIntravenous infusion of 3BNC117-LS at 30mg/kg	Drug	Study Participants
10-1074-LSAlso: Monoclonal AntibodyIntravenous infusion of 10-1074-LS at 30mg/kg	Drug	Study Participants

Primary outcome

Grade 3 and Serious Adverse Events
Time frame: 24 weeks
The number of participants with treatment-related solicited and unsolicited grade 3 and serious adverse events (including confirmed laboratory abnormalities).
Peak Concentration
Time frame: 24 weeks
Peak concentration of 3BNC117-LS and 10-1074-LS when administered intravenously and in combination to viremic HIV-infected individuals.
Half-life
Time frame: 24 weeks
Half-life of 3BNC117-LS and 10-1074-LS when administered intravenously and in combination to viremic HIV-infected individuals.
Area Under Curve
Time frame: 24 weeks
Area under curve of 3BNC117-LS and 10-1074-LS when administered intravenously and in combination to viremic HIV-infected individuals.
Maximum Decline in Plasma HIV-1 RNA Level
Time frame: 4 weeks
Maximum decline in plasma HIV-1 RNA level after 3BNC117-LS plus 10-1074-LS intravenous infusions in viremic HIV-infected individuals through week 4 after infusions.

3 secondary outcomes

Anti-drug Antibodies
Time frame: 24 weeks
Adverse Events
Time frame: 24 weeks
Laboratory Abnormalities
Time frame: 24 weeks

Results and safety

Results posted to the registry on 26 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Participants	6	4

Primary outcome: Grade 3 and Serious Adverse Events

Time frame: 24 weeks. Count of participants. Unit: Participants

Measure	Study Participants n = 6
Value	0

Primary outcome: Peak Concentration

Time frame: 24 weeks. Mean (Standard Deviation). Unit: mcg/ml

Measure	Study Participants n = 6
3BNC117-LS	719.83 (77.62)
10-1074-LS	915.15 (207.18)

Primary outcome: Half-life

Time frame: 24 weeks. Mean (Standard Deviation). Unit: days

Measure	Study Participants n = 6
3BNC117-LS	41.63 (11.71)
10-1074-LS	47.62 (15.38)

Primary outcome: Area Under Curve

Time frame: 24 weeks. Mean (Standard Deviation). Unit: (mcg x day)/mL

Measure	Study Participants n = 6
3BNC117-LS	13965.98 (2922.99)
10-1074-LS	34539.92 (34539.92)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected over 24 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Participants	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 principal investigator

The Rockefeller University

3 sites 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-LS and 10-1074-LS in people with Human Immunodeficiency Virus, run by Rockefeller University at 3 sites in United States.

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 5 inclusion and 19 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 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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?

Yes. Results are posted in the registry (first posted 26 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Grade 3 and Serious Adverse Events (time frame: 24 weeks). The study lists 5 primary outcomes in all. 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 NCT04250636.

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 Jun 2023.