Compassionate Use of Dolutegravir and Ibalizumab for the Treatment of HIV Infection
Expanded access is currently available for this treatment.
Verified January 2014 by University of Colorado, Denver
Information provided by (Responsible Party):
University of Colorado, Denver
First received: January 3, 2014
Last updated: January 6, 2014
Last verified: January 2014
Dolutegravir is a second-generation integrase inhibitor that is effective in suppressing HIV replication in individuals with resistance to first-generation integrase inhibitors. 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. Both Dolutegravir and ibalizumab have completed phase I and II clinical studies in HIV-negative and HIV-infected individuals showing that both are safe and effective for suppressing HIV replication.
Human Immunodeficiency Virus (HIV)
What is Expanded Access?
||Compassionate Use of Dolutegravir and 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.
- Dolutegravir is a second-generation integrase inhibitor that is effective in suppressing HIV replication in individuals with resistance to first-generation integrase inhibitors. 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. Both Dolutegravir and ibalizumab are in the pipeline for FDA approval to treat HIV infection. For both medications phase I and II clinical studies have been completed in HIV-negative and HIV-infected individuals showing that both are safe and effective for suppressing HIV replication.
- Use of these medications requires that a single patient IND be obtained from the FDA for each patient requiring dolutegravir and/or ibalizumab. Because treatment of HIV infection requires multiple active antiretroviral medications, the FDA requested that a single Investigational New Drug Application (IND) be utilized to cover both of these investigational medications. An individual use IND has been approved by the FDA; The IND number is 114515. The manufacturers of dolutegravir (ViiV Healthcare) and 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
||January 6, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 21, 2014
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