Compassionate Use of Ibalizumab for the Treatment of HIV Infection
University of Colorado, Denver
Information provided by (Responsible Party)
University of Colorado, Denver
First received: January 3, 2014
Last updated: October 31, 2016
Last Verified: October 2016
History of Changes
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.
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)|
- 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.
- Use of this medication requires that a single patient IND be obtained from the FDA for
Ages Eligible for Study: 18 Years to 89 Years Sexes Eligible for Study: All Accepts Healthy Volunteers: No
- 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.
- 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 LocationsChoosing 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 Show More
|United States, Colorado|
|Denver, Colorado, United States, 80204|
Sponsors and CollaboratorsUniversity of Colorado, Denver
|Principal Investigator:||Edward M Gardner, M.D.||University of Colorado, Denver|
|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:
Acquired Immunodeficiency Syndrome
ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.