Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV

NCT02475629 | Completed Phase 3 Results DMC

• 1 other identifier: TMB-301
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 30

Brief Summary

This Phase 3, single arm, multicenter study will evaluate the safety and effectiveness of ibalizumab in treatment-experienced patients infected with multi-drug resistant HIV-1.

Conditions

HIV

Outcome Measures

Primary Outcomes (2)

• Efficacy: Proportion of Participants Achieving a Viral Load Reduction of at Least 0.5 Log 10: ITT-MEF

  Proportion of participants (%) achieving a viral load reduction of at least 0.5 log from baseline (Day 7)

  Day 14

• Efficacy: Proportion of Subjects With a Viral Load Decrease of at Least 0.5 Log 10 - Protocol Correct

  Proportion of patients (%) with a viral load decrease of at least 0.5 log 10 from baseline (day 7)

  Day 14

Secondary Outcomes (15)

• Efficacy: Proportion of Patients With Undetectable Viral Load: ITT-MEF

  Week 25 /end of study

• Efficacy: Proportion of Patients With Undetectable HIV-RNA Levels: Protocol Correct

  Week 25/End of Study

• Mean Change in Viral Load as a Measure of Efficacy - ITT-MEF

  Day 7 and Day 14

• Mean Change in Viral Load as a Measure of Efficacy - Protocol Correct

  Day 7 and Day 14

• End of Study Viral Load Reductions as a Measure of Efficacy - Intent to Treat Analysis

  at Week 25/End of Study

Other Outcomes (1)

• Pharmacodynamics: CD4 Receptor Occupancy

  At Week 25/End of Study

Study Arms (1)

Open-Label Ibalizumab plus OBR

EXPERIMENTAL

2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.

Biological: ibalizumab; Drug: Optimized Background Regimen (OBR)

Interventions

ibalizumab BIOLOGICAL

2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Also known as: TNX-355, Hu1A8

Open-Label Ibalizumab plus OBR

Optimized Background Regimen (OBR) DRUG

All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Open-Label Ibalizumab plus OBR

Eligibility Criteria

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

You may qualify if:

• Are capable of understanding and have voluntarily signed the informed consent document
• Have documented HIV-1 infection by official, signed, written history (e.g., laboratory report), otherwise an HIV-antibody test will be performed
• Have no acquired immunodeficiency syndrome (AIDS)-defining events in the 3 months before Screening, other than cutaneous Kaposi's sarcoma or wasting syndrome due to HIV
• Are able and willing to comply with all protocol requirements and procedures
• Have a life expectancy that is \>6 months.
• Have a viral load \>1,000 copies/mL and documented resistance to at least one antiretroviral medication from each of three classes of antiretroviral medications as measured by resistance testing
• Have a history of at least 6 months on antiretroviral treatment
• Are receiving a stable highly active antiretroviral regimen for at least 8 weeks before Screening and are willing to continue that regimen until Day 14, OR (in the past 8 weeks) have failed and are off therapy and are willing to stay off therapy until Day 14
• Have full viral sensitivity/susceptibility to at least one antiretroviral agent, other than ibalizumab, as determined by the screening resistance tests and be willing and able to be treated with at least one agent to which the patient's viral isolate is fully sensitive/susceptible according to the screening resistance tests as a component of OBR
• If sexually active, are willing to use an effective method of contraception during the study and for 30 days after the last administration of the study drug

You may not qualify if:

• Any active AIDS-defining illness per Category C conditions according to the Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection, with the following exceptions: cutaneous Kaposi's sarcoma and wasting syndrome due to HIV
• Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from screening, medical history and/or physical examination that, in the investigator's opinion, would preclude the patient from participating in this study
• Any significant acute illness within 1 week before the initial administration of study drug
• Any active infection secondary to HIV requiring acute therapy; however, patients that require maintenance therapy (i.e., secondary prophylaxis for opportunistic infections) will be eligible for the study.
• Any immunomodulating therapy (including interferon), systemic steroids, or systemic chemotherapy within 12 weeks before Enrollment
• Any prior exposure to ibalizumab (formerly TNX-355 and Hu5A8)
• Any vaccination within 7 days before Enrollment
• Any female patient who either is pregnant, intends to become pregnant, or is currently breastfeeding
• Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the patient's ability to comply with the study schedule and protocol evaluations
• Any previous clinically significant allergy or hypersensitivity to any excipient in the ibalizumab formulation
• Any radiation therapy during the 28 days before first administration of investigational medication
• Any Grade 3 or 4 laboratory abnormality according to the Division of AIDS grading scale, except for the following asymptomatic Grade 3 events triglyceride elevation total cholesterol elevation

Sponsors & Collaborators

• TaiMed Biologics Inc.: lead

Study Sites (30)

Long Beach Education and Research Consultants

Long Beach, California, 90813, United States

Location

W King Health Care Group

Los Angeles, California, 90008, United States

Location

Southern California Permanente Medical Group

Los Angeles, California, 90027, United States

Location

Ruane Medical and Clinical Research Institute

Los Angeles, California, 90036, United States

Location

Charles R. Drew Univ. of Med. & Science Clinical and Translational Research Center

Los Angeles, California, 90059, United States

Location

Anthony Mills, MD, Inc.

Los Angeles, California, 90069, United States

Location

AIDS Healthcare Foundation

Los Angeles, California, 90211, United States

Location

Palmtree Clinical Research Inc.

Palm Springs, California, 92262, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

Kaiser Foundation Research Institute

San Francisco, California, 94118, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Circle Care Center, LLC

Norwalk, Connecticut, 06850, United States

Location

Georgetown University School of Medicine

Washington D.C., District of Columbia, 20007, United States

Location

Gary Richmond, MD, PA

Fort Lauderdale, Florida, 33316, United States

Location

Midway Immunology and Research Center

Ft. Pierce, Florida, 34982, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Triple O Research Institute

West Palm Beach, Florida, 33401, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30312, United States

Location

University of Maryland, Institute of Human Virology

Baltimore, Maryland, 21201, United States

Location

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

Location

St. John Hospital and Medical Center

Southfield, Michigan, 48075, United States

Location

ACRIA

New York, New York, 10018, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Carolinas HealthCare System

Charlotte, North Carolina, 28232, United States

Location

North Texas Infectious Disease Consultants

Dallas, Texas, 75246, United States

Location

Research Access Network

Houston, Texas, 77098, United States

Location

Clinical Research PR, Inc

San Juan, 75246, Puerto Rico

Location

E-Da Hospital

Kaohsiung City, 82445, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Related Publications (1)

• Emu B, Fessel J, Schrader S, Kumar P, Richmond G, Win S, Weinheimer S, Marsolais C, Lewis S. Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1. N Engl J Med. 2018 Aug 16;379(7):645-654. doi: 10.1056/NEJMoa1711460.

  PMID: 30110589 DERIVED

MeSH Terms

Interventions

ibalizumab

Results Point of Contact

• Title: Manager - Clinical Services
• Organization: TaiMed Biologics USA Corp.

bbell@taimedbio.com

(949) 331-3225

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 19, 2015
• Study Start: August 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2020-02

Locations

US (27); PR (1); TW (2)