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

PHASE3CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

October 31, 2016

Study Completion Date

December 31, 2016

Conditions
HIV
Interventions
BIOLOGICAL

ibalizumab

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

DRUG

Optimized Background Regimen (OBR)

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.

Trial Locations (30)

10002

National Taiwan University Hospital, Taipei

10018

ACRIA, New York

10467

Montefiore Medical Center, The Bronx

20007

Georgetown University School of Medicine, Washington D.C.

21201

University of Maryland, Institute of Human Virology, Baltimore

28232

Carolinas HealthCare System, Charlotte

30312

AIDS Research Consortium of Atlanta, Atlanta

32803

Orlando Immunology Center, Orlando

33136

University of Miami, Miami

33316

Gary Richmond, MD, PA, Fort Lauderdale

33401

Triple O Research Institute, West Palm Beach

34982

Midway Immunology and Research Center, Ft. Pierce

48075

St. John Hospital and Medical Center, Southfield

48202

Henry Ford Health Systems, Detroit

75246

North Texas Infectious Disease Consultants, Dallas

Clinical Research PR, Inc, San Juan

77098

Research Access Network, Houston

82445

E-Da Hospital, Kaohsiung City

90008

W King Health Care Group, Los Angeles

90027

Southern California Permanente Medical Group, Los Angeles

90036

Ruane Medical and Clinical Research Institute, Los Angeles

90059

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

90069

Anthony Mills, MD, Inc., Los Angeles

90211

AIDS Healthcare Foundation, Los Angeles

90813

Long Beach Education and Research Consultants, Long Beach

92262

Palmtree Clinical Research Inc., Palm Springs

94115

Quest Clinical Research, San Francisco

94118

Kaiser Foundation Research Institute, San Francisco

06510

Yale University, New Haven

06850

Circle Care Center, LLC, Norwalk

All Listed Sponsors
lead

TaiMed Biologics Inc.

INDUSTRY

NCT02475629 - Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV | Biotech Hunter | Biotech Hunter