Compassionate Use of Ibalizumab for the Treatment of HIV Infection

• Status: No longer available
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Antibodies, Monoclonal; Dolutegravir; Ibalizumab

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