HIV-1 InfectionPhase 2NCT02588586
A Study of the Safety and Antiretroviral Activity of 3BNC117
A Phase 2 study testing 3BNC117 and Antiretroviral Treatment Interruption in people with HIV-1 Infection, run by Rockefeller University at 2 sites in United States.
Trial summary
This study evaluates the effects of four infusions of 3BNC117 in preventing or delaying rebound of viral load during a brief treatment interruption of standard ART, and its safety during a brief analytical interruption of antiretroviral therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- 3BNC117 and Antiretroviral Treatment Interruption
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2015to Apr 2018
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained and signed.
- Males and females, age 18 to 65.
- HIV-1 infection confirmed by two independent methods.
- Plasma HIV-1 RNA < 50 copies/ml for at least 12 months while on combination ART and < 20 copies/ml at the screening visit. [Note: One or two viral blips of < 200 copies/mL prior to enrollment are permitted if preceded and followed by test results showing VL less than or equal to 50 copies/ml on the same ARV regimen.]
- CD4 cell count > 500 cells/microliter. CD4 cell count nadir > 200 cells/microliter.
- If sexually active male or female, and participating in sexual activity that could lead to pregnancy, agrees to use an effective method of contraception throughout the study period. Participants should also agree to use a male or female condom while off ART.
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- Female study participants of reproductive potential are defined as pre-menopausal women who have not had a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, tubal ligation or salpingectomy). Women are considered menopausal if they have not had a menses for at least 12 months and have a FSH of greater than 40 IU/L or if FSH testing is not available, they have had amenorrhea for 24 consecutive months.
- Acceptable forms of contraception must include one of the following: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, IUD, or hormone-based contraceptive.
- If on an NNRTI-based regimen willing to a switch for 4 weeks to a dolutegravir-based regimen.
Who cannot join
- Have a history of AIDS-defining illness within 1 year prior to enrollment.
- Have a history of resistance to two or more antiretroviral drug classes.
- History of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months.
- Chronic hepatitis B or hepatitis C.
- Participant report, or chart history, of significant coronary artery disease, myocardial infarction, percutaneous coronary intervention with placement of cardiac stents.
- Participant report, or chart history, of diabetes type 1 or 2 and/or current use of insulin or oral hypoglycemic medications.
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- Uncontrolled hypertension, as defined by a systolic blood pressure > 180 and/or diastolic blood pressure > 120, in the presence or absence of anti-hypertensive medications.
- Total cholesterol level > 240 mg/dl or LDL level > 190 mg/dl at screen.
- Known family history of myocardial infarction or stroke in a first-degree relative aged < 60 years.
- Any other clinically significant acute or chronic medical condition, such as autoimmune diseases, that in the opinion of the investigator would preclude participation.
- Current cigarette use in excess of 1 pack per day;
- Laboratory abnormalities in the parameters listed below:
- Absolute neutrophil count less than or equal to 1,000 cells/microliter
- Hemoglobin less than or equal to 10 g/dL
- Platelet count less than or equal to 125,000 cells/microliter
- ALT greater than or equal to 2.0 x ULN
- AST greater than or equal to 2.0 x ULN
- Total bilirubin greater than or equal to 1.5 ULN
- Creatinine greater than or equal to 1.1 x ULN
- Coagulation parameters greater than or equal to 1.5 x ULN.
- Current antiretroviral regimen includes maraviroc or enfuvirtide.
- Pregnancy or lactation.
- Any vaccination within 14 days prior to 3BNC117 administration.
- Receipt of monoclonal antibody therapy of any kind in the past.
- History of severe reaction to drug infusions or history of severe allergic reactions.
- 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
2 sites in 1 country.
United States2 sites
The Rockefeller University
New York, New York, 10065
Weill Cornel Medical Center
New York, New York, 10065
About this study
Official title: An Open Label, Phase 2 Study of the Safety and Antiretroviral Activity of 3BNC117 in HIV-Infected Individuals on Combination Antiretroviral Therapy
This study evaluates the effects of four infusions of 3BNC117 in preventing or delaying rebound of viral load during a brief treatment interruption of standard ART, and its safety during a brief analytical interruption of antiretroviral therapy.
Read the detailed description
The proposed study is a Phase II, open label study to evaluate the safety, antiretroviral activity and pharmacokinetics of four infusions of 3BNC117 in HIV-infected individuals on combination ART and during a brief analytical treatment interruption (ATI).
Study participants will be administered four intravenous infusions of 3BNC117, administered at 30 mg/kg on day 0, week 12, week 24 and week 27. Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion (week 24), until week 36.
The ART regimen will be resumed at week 36 or sooner if plasma HIV-1 RNA level is ≥ 200 copies/ml, CD4+ T cell count drops < 350 cells/microliter, and results are confirmed upon repeat measurement during the next weekly scheduled visit. If plasma HIV-1 RNA level is ≥ 1,000 copies/ml, the participant will be asked to return for a repeat measurement prior to the next scheduled visit, and ART will be resumed if results are confirmed. ART will also be resumed early if the participant becomes pregnant or if otherwise clinically indicated. If ART is resumed before week 27, the fourth 3BNC117 infusion will not be administered.
Participants will be followed weekly during the analytical treatment interruption phase for safety assessments and for monitoring plasma HIV-1 RNA levels. CD4+ T cell counts will be monitored every 2 weeks during the analytical treatment interruption phase.
Participants may remain off antiretroviral therapy after week 36, with weekly viral load monitoring, if viral rebound does not occur by week 36.
All participants will be followed for a total of 60 weeks from enrollment.
- Conditions
- HIV-1 Infection
- Being tested
- 3BNC117, Antiretroviral Treatment Interruption
- Keywords
- HIV, 3BNC117, Broadly neutralizing antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3BNC117Drug
Also called 3BNC117 antibody
3BNC117 infusions
Antiretroviral Treatment InterruptionOther
Also called Treatment Interruption
Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion, at week 24, and resumed at week 36.
| Study group | Role | What they receive |
|---|---|---|
| 3BNC117 + ART Interruption | Experimental | Four intravenous infusions of 3BNC117 (30mg/kg) at weeks 0, 12, 24 and 27, and antiretroviral treatment interruption (ART)at week 24. Receives: Drug: 3BNC117; Other: Antiretroviral Treatment Interruption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Viral Rebound at 12 Weeks After Interruption of Antiretroviral Therapy
Viral rebound is defined as confirmed plasma HIV-1 RNA level > 200 copies/ml in two separate occasions
Measured: 36 weeks
Secondary outcomes (3)
Serum Level of 3BNC117 at the Time of Viral Rebound, Measured in Micrograms Per ml
Serum level of 3BNC117 at the time of viral rebound, measured in micrograms per ml
Measured: 12 weeks
Time to Viral Rebound After Interruption of Antiretroviral Therapy
Viral rebound is defined as confirmed plasma HIV-1 RNA level > 200 copies/ml in two separate occasions
Measured: 36 weeks
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionFeb 2018
- Study completionApr 2018
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 HIV-1 InfectionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Bill and Melinda Gates Foundation, Weill Medical College of Cornell University, Montefiore Medical Center
- Responsible party
- Principal investigator, Marina Caskey, MD, Rockefeller University
- Investigators
- Marina Caskey, MD, Principal investigator, The Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588586
- Sponsor's protocol ID
- MCA-0866
- Other IDs
- 1U01AI118536-01
- Status last verified
- May 2021
- First submitted
- 26 Oct 2015
- Last updated
- 16 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase 2 Study of the Safety and Antiretroviral Activity of 3BNC117 in HIV-Infected Individuals on Combination Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT02588586
- Acronym / sponsor ID
- MCA-0866
- Conditions
- HIV-1 Infection
- Keywords
- HIV, 3BNC117, Broadly neutralizing antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Bill and Melinda Gates Foundation, Weill Medical College of Cornell University, Montefiore Medical Center
- Study start
- Oct 2015
- Primary completion
- Feb 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Posted 16 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effects of four infusions of 3BNC117 in preventing or delaying rebound of viral load during a brief treatment interruption of standard ART, and its safety during a brief analytical interruption of antiretroviral therapy.
Detailed description
The proposed study is a Phase II, open label study to evaluate the safety, antiretroviral activity and pharmacokinetics of four infusions of 3BNC117 in HIV-infected individuals on combination ART and during a brief analytical treatment interruption (ATI).
Study participants will be administered four intravenous infusions of 3BNC117, administered at 30 mg/kg on day 0, week 12, week 24 and week 27. Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion (week 24), until week 36.
The ART regimen will be resumed at week 36 or sooner if plasma HIV-1 RNA level is ≥ 200 copies/ml, CD4+ T cell count drops < 350 cells/microliter, and results are confirmed upon repeat measurement during the next weekly scheduled visit. If plasma HIV-1 RNA level is ≥ 1,000 copies/ml, the participant will be asked to return for a repeat measurement prior to the next scheduled visit, and ART will be resumed if results are confirmed. ART will also be resumed early if the participant becomes pregnant or if otherwise clinically indicated. If ART is resumed before week 27, the fourth 3BNC117 infusion will not be administered.
Participants will be followed weekly during the analytical treatment interruption phase for safety assessments and for monitoring plasma HIV-1 RNA levels. CD4+ T cell counts will be monitored every 2 weeks during the analytical treatment interruption phase.
Participants may remain off antiretroviral therapy after week 36, with weekly viral load monitoring, if viral rebound does not occur by week 36.
All participants will be followed for a total of 60 weeks from enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3BNC117 + ART Interruption | Experimental | Drug: 3BNC117, Other: Antiretroviral Treatment InterruptionFour intravenous infusions of 3BNC117 (30mg/kg) at weeks 0, 12, 24 and 27, and antiretroviral treatment interruption (ART)at week 24. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Informed consent obtained and signed.
- Males and females, age 18 to 65.
- HIV-1 infection confirmed by two independent methods.
- Plasma HIV-1 RNA < 50 copies/ml for at least 12 months while on combination ART and < 20 copies/ml at the screening visit. [Note: One or two viral blips of < 200 copies/mL prior to enrollment are permitted if preceded and followed by test results showing VL less than or equal to 50 copies/ml on the same ARV regimen.]
- CD4 cell count > 500 cells/microliter. CD4 cell count nadir > 200 cells/microliter.
Key exclusion criteria (26 listed)
- Have a history of AIDS-defining illness within 1 year prior to enrollment.
- Have a history of resistance to two or more antiretroviral drug classes.
- History of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months.
- Chronic hepatitis B or hepatitis C.
- Participant report, or chart history, of significant coronary artery disease, myocardial infarction, percutaneous coronary intervention with placement of cardiac stents.
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 |
|---|---|---|
| 3BNC117Also: 3BNC117 antibody3BNC117 infusions | Drug | 3BNC117 + ART Interruption |
| Antiretroviral Treatment InterruptionAlso: Treatment InterruptionAntiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion, at week 24, and resumed at week 36. | Other | 3BNC117 + ART Interruption |
Primary outcome
Rate of Viral Rebound at 12 Weeks After Interruption of Antiretroviral Therapy
Time frame: 36 weeks
Viral rebound is defined as confirmed plasma HIV-1 RNA level > 200 copies/ml in two separate occasions
3 secondary outcomes
Serum Level of 3BNC117 at the Time of Viral Rebound, Measured in Micrograms Per ml
Time frame: 12 weeks
Time to Viral Rebound After Interruption of Antiretroviral Therapy
Time frame: 36 weeks
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 60 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- 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, MD principal investigator
The Rockefeller University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 3BNC117 and Antiretroviral Treatment Interruption in people with HIV-1 Infection, run by Rockefeller University at 2 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 9 inclusion and 26 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 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 16 Jun 2021). 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?
Rate of Viral Rebound at 12 Weeks After Interruption of Antiretroviral Therapy (time frame: 36 weeks). 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 16 Jun 2021.