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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
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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 |
Resource links provided by NLM:
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) |
Intervention Details:
Detailed Description:
-
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
- 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.
Eligibility| Ages Eligible for Study: | 18 Years to 89 Years (Adult, Senior) |
| 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
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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
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
| 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 Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Slow Virus Diseases Dolutegravir |
Antibodies, Monoclonal HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 17, 2017