Compassionate Use of Ibalizumab for the Treatment of HIV Infection
Expanded access is currently available for this treatment.
Verified June 2015 by University of Colorado, Denver
Information provided by (Responsible Party):
University of Colorado, Denver
First received: January 3, 2014
Last updated: June 8, 2015
Last verified: June 2015
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)
What is Expanded Access?
||Compassionate Use of Ibalizumab for the Treatment of HIV Infection
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||February 2014 (Final data collection date for primary outcome measure)
Dolutegravir taken 50mg orally twice daily
Ibalizumab will be administered intravenously at a dose of 800mg once every two weeks.
- 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 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.
|Ages Eligible for Study:
||18 Years to 89 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
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
|Denver, Colorado, United States, 80204 |
|Contact: Edward M Gardner, M.D. 303-315-7424 EDWARD.GARDNER@UCDENVER.EDU |
|Principal Investigator: Edward M Gardner, M.D. |
University of Colorado, Denver
No publications provided
||University of Colorado, Denver
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 3, 2014
||June 8, 2015
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 30, 2015
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Immune System Diseases
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
HIV Integrase Inhibitors
Molecular Mechanisms of Pharmacological Action