Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV
Condition: HIV
Intervention: ibalizumab; Optimized Background Regimen (OBR)
Intervention description: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks; All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.
Intervention MeSH terms: Ibalizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This Phase 3, single arm, multicenter study will evaluate the safety and effectiveness of
      ibalizumab in treatment-experienced patients infected with multi-drug resistant HIV-1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are capable of understanding and have voluntarily signed the informed consent document

          -  Have documented HIV-1 infection by official, signed, written history (e.g., laboratory
             report), otherwise an HIV-antibody test will be performed

          -  Have no acquired immunodeficiency syndrome (AIDS)-defining events in the 3 months
             before Screening, other than cutaneous Kaposi's sarcoma or wasting syndrome due to HIV

          -  Are able and willing to comply with all protocol requirements and procedures

          -  Have a life expectancy that is >6 months.

          -  Have a viral load >1,000 copies/mL and documented resistance to at least one
             antiretroviral medication from each of three classes of antiretroviral medications as
             measured by resistance testing

          -  Have a history of at least 6 months on antiretroviral treatment

          -  Are receiving a stable highly active antiretroviral regimen for at least 8 weeks
             before Screening and are willing to continue that regimen until Day 14, OR (in the
             past 8 weeks) have failed and are off therapy and are willing to stay off therapy
             until Day 14

          -  Have full viral sensitivity/susceptibility to at least one antiretroviral agent, other
             than ibalizumab, as determined by the screening resistance tests and be willing and
             able to be treated with at least one agent to which the patient's viral isolate is
             fully sensitive/susceptible according to the screening resistance tests as a component
             of OBR

          -  If sexually active, are willing to use an effective method of contraception during the
             study and for 30 days after the last administration of the study drug

        Exclusion Criteria:

          -  Any active AIDS-defining illness per Category C conditions according to the Centers
             for Disease Control and Prevention (CDC) Classification System for HIV Infection, with
             the following exceptions: cutaneous Kaposi's sarcoma and wasting syndrome due to HIV

          -  Any significant diseases (other than HIV-1 infection) or clinically significant
             findings, including psychiatric and behavioral problems, determined from screening,
             medical history and/or physical examination that, in the investigator's opinion, would
             preclude the patient from participating in this study

          -  Any significant acute illness within 1 week before the initial administration of study
             drug

          -  Any active infection secondary to HIV requiring acute therapy; however, patients that
             require maintenance therapy (i.e., secondary prophylaxis for opportunistic infections)
             will be eligible for the study.

          -  Any immunomodulating therapy (including interferon), systemic steroids, or systemic
             chemotherapy within 12 weeks before Enrollment

          -  Any prior exposure to ibalizumab (formerly TNX-355 and Hu5A8)

          -  Any vaccination within 7 days before Enrollment

          -  Any female patient who either is pregnant, intends to become pregnant, or is currently
             breastfeeding

          -  Any current alcohol or illicit drug use that, in the investigator's opinion, will
             interfere with the patient's ability to comply with the study schedule and protocol
             evaluations

          -  Any previous clinically significant allergy or hypersensitivity to any excipient in
             the ibalizumab formulation

          -  Any radiation therapy during the 28 days before first administration of
             investigational medication

          -  Any Grade 3 or 4 laboratory abnormality according to the Division of AIDS grading
             scale, except for the following asymptomatic Grade 3 events triglyceride elevation
             total cholesterol elevation