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

NCT04250636 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: MCA-09941U01AI145921
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Human Immunodeficiency Virus

Keywords

3BNC117-LS; 10-1074-LS; Broadly Neutralizing Antibody

Outcome Measures

Primary Outcomes (5)

• 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).

  24 weeks

• Peak Concentration

  Peak concentration of 3BNC117-LS and 10-1074-LS when administered intravenously and in combination to viremic HIV-infected individuals.

  24 weeks

• Half-life

  Half-life of 3BNC117-LS and 10-1074-LS when administered intravenously and in combination to viremic HIV-infected individuals.

  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.

  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.

  4 weeks

Secondary Outcomes (3)

• Anti-drug Antibodies

  24 weeks

• Adverse Events

  24 weeks

• Laboratory Abnormalities

  24 weeks

Study Arms (1)

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.

Drug: 3BNC117-LS; Drug: 10-1074-LS

Interventions

3BNC117-LS DRUG

Intravenous infusion of 3BNC117-LS at 30mg/kg

Also known as: Monoclonal Antibody

Study Participants

10-1074-LS DRUG

Intravenous infusion of 10-1074-LS at 30mg/kg

Also known as: Monoclonal Antibody

Study Participants

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Rockefeller University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Weill Medical College of Cornell University: collaborator
• University of Pennsylvania: collaborator

Study Sites (3)

Weill Cornell Medical Center Clinical Trials Unit-CLOSED SITE

New York, New York, 10021, United States

Location

The Rockefeller University

New York, New York, 10065, United States

Location

Perelman School of Medicine University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Antibodies, Monoclonal

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Marina Caskey
• Organization: The Rockefeller University

mcaskey@rockefeller.edu

2123277396

Study Officials

• Marina Caskey

  The Rockefeller University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: January 31, 2020
• Study Start: October 13, 2020
• Primary Completion: January 21, 2022
• Study Completion: February 11, 2022
• Last Updated: June 26, 2023
• Results First Posted: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)