A Study of the Safety and Antiretroviral Activity of 3BNC117

NCT02588586 | Completed Phase 2 Results DMC

• 2 other identifiers: MCA-08661U01AI118536-01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HIV-1 Infection

Keywords

HIV; 3BNC117; Broadly neutralizing antibody

Outcome Measures

Primary Outcomes (1)

• 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

  36 weeks

Secondary Outcomes (3)

• Serum Level of 3BNC117 at the Time of Viral Rebound, Measured in Micrograms Per ml

  12 weeks

• Time to Viral Rebound After Interruption of Antiretroviral Therapy

  36 weeks

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  60 weeks

Study Arms (1)

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.

Drug: 3BNC117; Other: Antiretroviral Treatment Interruption

Interventions

3BNC117 DRUG

3BNC117 infusions

Also known as: 3BNC117 antibody

3BNC117 + ART Interruption

Antiretroviral Treatment Interruption OTHER

Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion, at week 24, and resumed at week 36.

Also known as: Treatment Interruption

3BNC117 + ART Interruption

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Rockefeller University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Bill and Melinda Gates Foundation: collaborator
• Weill Medical College of Cornell University: collaborator
• Montefiore Medical Center: collaborator

Study Sites (2)

The Rockefeller University

New York, New York, 10065, United States

Location

Weill Cornel Medical Center

New York, New York, 10065, United States

Location

MeSH Terms

Interventions

3BNC117 antibody; Treatment Interruption

Intervention Hierarchy (Ancestors)

Treatment Adherence and Compliance; Attitude to Health; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Limitations and Caveats

This study was an exploratory open label study with a small sample size.

Results Point of Contact

• Title: Dr. Marina Caskey, Professor of Clinical Investigation
• Organization: The Rockefeller University

mcaskey@rockefeller.edu

2123277396

Study Officials

• Marina Caskey, MD

  The Rockefeller University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Investigation

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: October 28, 2015
• Study Start: October 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: April 1, 2018
• Last Updated: June 16, 2021
• Results First Posted: June 16, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)