3BNC117 Monoclonal Antibody in HIV-infected Subjects During Treatment Interruption

NCT02446847 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: MCA-0867
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effects of two 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 (2)

• Number of Participants With Virologic Rebound at 8 Weeks After Interruption of Antiretroviral Therapy

  Virologic rebound is defined as confirmed plasma HIV-1 RNA level \> 200 copies/ml in two separate occasions

  8 weeks

• The Rate of Signs, Symptoms and Laboratory Abnormalities After 3BNC117 Infusions

  The percentage of participants who experienced adverse events (e.g. signs, symptoms and laboratory abnormalities) following 3BNC117 infusions.

  36 weeks

Secondary Outcomes (1)

• The Plasma Level of 3BNC117 at the Time of Viral Rebound.

  36 weeks

Study Arms (2)

Group A: 3BNC117 IV + ART Interruption

EXPERIMENTAL

Two intravenous infusions of 3BNC117 (30 mg/kg) at day 0 and day 21, with interruption of antiretroviral treatment (ART) at day 2.

Drug: 3BNC117; Other: ART Interruption

Group B: 3BNC117 IV + ART interruption

EXPERIMENTAL

Four intravenous infusions of 3BNC117 (30 mg/kg) at day 0, day 14, day 28, and day 42 with interruption of antiretroviral treatment (ART) at day 2.

Drug: 3BNC117; Other: ART Interruption

Interventions

3BNC117 DRUG

3BNC117 infusions

Also known as: 3BNC117 antibody

Group A: 3BNC117 IV + ART Interruption; Group B: 3BNC117 IV + ART interruption

ART Interruption OTHER

Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12.

Also known as: Treatment Interruption

Group A: 3BNC117 IV + ART Interruption; Group B: 3BNC117 IV + 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:

• Age 18 to 65
• HIV-1 infection confirmed by ELISA and immunoblot.
• Plasma HIV-1 RNA \< 50 copies/ml for at least 12 months while on combination ART and \< 20 copies/ml at the screening visit. \[Note: One or two viral blips of \< 200 copies/mL prior to enrollment are permitted if preceded and followed by test results showing VL less than or equal to 50 copies/mL on the same ARV regimen.\]
• BNC117 sensitivity (IC50 \< 2 μg/ml) of subject derived HIV-1 virus isolates. These are isolated under protocol MCA-823 by co-culture of subject PBMCs with HIV-uninfected donor PBMCs followed by in vitro neutralization assays as previously described
• Current CD4 cell count \> 500 cells/μl and no prior CD4 cell count \< 200 cells/μl.
• Willing to interrupt antiretroviral treatment for 12 weeks, or until viral rebound occurs.
• If sexually active male or female, and participating in sexual activity that could lead to pregnancy using an effective method of contraception throughout the study period. Subjects should also agree to use a male or female condom during the time of pausing their HIV medication.
• If on an NNRTI-based regimen willing to a switch for 4 weeks to dolutegravir.

You may not qualify if:

• Have a history of AIDS-defining illness within 1 year prior to enrollment
• 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;
• Patient report, or chart history, of significant coronary artery disease, myocardial infarction, percutaneous coronary intervention with placement of cardiac stents;
• Patient 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;
• 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 ≤1,000
• Hemoglobin ≤ 10 gm/dL
• Platelet count ≤125,000
• ALT ≥ 2.0 x ULN
• AST ≥ 2.0 x ULN
• Total bilirubin ≥ 1.5 ULN

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

The Rockefeller University

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

Results Point of Contact

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

mcaskey@rockefeller.edu

212-327-7396

Study Officials

• Marina Caskey, MD

  The Rockefeller University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: May 18, 2015
• Study Start: March 11, 2015
• Primary Completion: March 25, 2017
• Study Completion: March 25, 2017
• Last Updated: July 23, 2020
• Results First Posted: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)