Clinical Trials

MainTitle

Compassionate Use of Ibalizumab for the Treatment of HIV Infection

Expanded access is no longer available for this treatment.
Sponsor
University of Colorado, Denver


Information provided by (Responsible Party)
University of Colorado, Denver
ClinicalTrials.gov Identifier
NCT02028819

First received: January 3, 2014
Last updated: October 31, 2016
Last Verified: October 2016
History of Changes
Purpose

Purpose

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.

Condition Intervention
Human Immunodeficiency Virus (HIV)

Drug : Dolutegravir Sodium Monohydrate
Drug : Ibalizumab

Study Type: Expanded Access   What is Expanded Access?
Official Title: Compassionate Use of Ibalizumab for the Treatment of HIV Infection

Further study details as provided by University of Colorado, Denver:

Study Start Date: January 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)

Detailed Description:

  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.
    1. 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.

    Eligibility

    Eligibility

    Ages Eligible for Study: 18 Years to 89 Years  
    Sexes Eligible for Study: All  
    Accepts Healthy Volunteers: No  

    Criteria

    Inclusion Criteria:

    • Adult patients with a diagnosis of HIV-infection with resistance or intolerance to currently available antiretroviral medications available in the United States or in whom additional drugs need to be added to their regimen because of inadequate response to existing therapy
    • Patients with HIV infection that is expected to be sensitive to dolutegravir and ibalizumab
    • Patients who do not qualify for or who are otherwise ineligible for clinical trials of medications not currently approved for treatment of HIV infection in the U.S.


Exclusion Criteria:
  • Patients who are allergic to or have had a severe adverse reaction to dolutegravir or ibalizumab in the past.
  • Age <18 years or >89 years
  • Women may not be pregnant
  • Prisoners and decisionally challenged patients will be excluded

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02028819

Locations

United States, Colorado
Denver Health
Denver, Colorado, United States, 80204

Sponsors and Collaborators

University of Colorado, Denver

Investigators

Principal Investigator: Edward M Gardner, M.D. University of Colorado, Denver
More Information

More Information


Responsible Party: University of Colorado, Denver  
ClinicalTrials.gov Identifier: NCT02028819   History of Changes  
Other Study ID Numbers: 12-0003  
Study First Received: January 3, 2014  
Last Updated: October 31, 2016  

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Dolutegravir
Ibalizumab

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.