Compassionate Use of Ibalizumab for the Treatment of HIV Infection

1. 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.

2. 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.

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