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
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02028819
First received: January 3, 2014
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Human Immunodeficiency Virus (HIV)
Drug: Dolutegravir
Drug: Ibalizumab
Phase 3

Study Type: Expanded Access     What is Expanded Access?
Official Title: Compassionate Use of Dolutegravir and 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:
    Drug: Dolutegravir
    Dolutegravir taken 50mg orally twice daily
    Drug: Ibalizumab
    Ibalizumab will be administered intravenously at a dose of 800mg once every two weeks.
Detailed Description:
  1. 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.
  2. 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.
  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
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
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

Contacts
Contact: Edward M Gardner, M.D. (303) 315-7424 EDWARD.GARDNER@UCDENVER.EDU

Locations
United States, Colorado
Denver Health
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.         
Sponsors and Collaborators
University of Colorado, Denver
  More Information

No publications provided

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: January 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Dolutegravir
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014