We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Compassionate Use of Ibalizumab for the Treatment of HIV Infection

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02028819
First Posted: January 7, 2014
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Colorado, Denver
January 3, 2014
January 7, 2014
November 1, 2016
 
Compassionate Use of Ibalizumab for the Treatment of HIV Infection
Ibalizumab is a humanized immunoglobulin G monoclonal antibody directed against a human T-cell receptor (CD4) and thus suppresses HIV replication by blocking entry of HIV into CD4+ lymphocytes. Ibalizumab has completed phase I and II clinical studies in HIV-negative and HIV-infected individuals showing safety and efficacy for suppressing HIV replication.
  1. Ibalizumab is a humanized immunoglobulin G monoclonal antibody directed against a human T-cell receptor (CD4) and thus suppresses HIV replication by blocking entry of HIV into CD4+ lymphocytes. Ibalizumab is in the pipeline for FDA approval to treat HIV infection. Phase I and II clinical studies have been completed in HIV-negative and HIV-infected individuals showing safety and efficacy for suppressing HIV replication.
  2. Use of this medication requires that a single patient IND be obtained from the FDA for each patient requiring ibalizumab. An individual use IND has been approved by the FDA for one patient on treatment through this protocol; The IND number is 114515. The manufacturer of ibalizumab (TaiMed Biologics, Inc) will ship the drug directly to the Denver Health pharmacy.
Expanded Access
  • Drug: Dolutegravir Sodium Monohydrate
    Dolutegravir taken 50mg orally twice daily
    Other Name: TIVICAY
  • Drug: Ibalizumab
    Ibalizumab will be administered intravenously at a dose of 800mg once every two weeks.
    Other Name: TMB-355
Not Provided
 
No longer available
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02028819
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Edward M Gardner, M.D. University of Colorado, Denver
University of Colorado, Denver
October 2016