3BNC117-LS and 10-1074-LS in Viremic HIV-infected Individuals
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: 3BNC117-LS; 10-1074-LS
Intervention description: Intravenous infusion of 3BNC117-LS at 30mg/kg; Intravenous infusion of 10-1074-LS at 30mg/kg
Intervention MeSH terms: Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 3BNC117-LS; 10-1074-LS; Broadly Neutralizing Antibody

Summary:

      The proposed study is a phase 1, open label, single arm study to evaluate the safety,
      pharmacokinetics and antiviral activity of single intravenous infusions of 3BNC117-LS and
      10-1074-LS, each monoclonal antibody (mAb) dosed at 30 mg/kg in viremic human
      immunodeficiency virus (HIV)-infected individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females, >18 years of age.

          2. Confirmed HIV-1 infection.

          3. Off ART for at least 4 weeks with a HIV-1 plasma RNA level between 500 and 100,000
             copies/mL (ART-naïve or off ART due to intolerance or by choice).

          4. Current CD4+ T cell count > 300 cells/μl.

          5. If sexually active male or female, and participating in sexual activity that could
             lead to pregnancy or transmission of HIV, agrees to use two effective methods of
             contraception (i.e. condom with spermicide, diaphragm with spermicide, hormone-eluting
             IUD, hormone-based contraceptive with condom) from 10 days prior to and six months
             after 3BNC117-LS and 10-1074-LS administration.

        Exclusion Criteria:

          1. Have a history of AIDS-defining illness within 3 years prior to enrollment.

          2. History of systemic corticosteroids, immunosuppressive anti-cancer, or other
             medications considered significant by the trial physician within the last 6 months.

          3. Any clinically significant acute or chronic medical condition (such as autoimmune
             diseases), other than HIV infection, that in the opinion of the investigator would
             preclude participation.

          4. Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen
             (HBsAg) or hepatitis C virus RNA (HCV-RNA) in blood.

          5. Laboratory abnormalities in the parameters listed below:

               -  Absolute neutrophil count ≤ 1,000 cells/μl;

               -  Hemoglobin ≤ 10 gm/dL;

               -  Platelet count ≤ 100,000 cells/μl;

               -  ALT ≥ 1.5 x ULN;

               -  AST ≥ 1.5 x ULN;

               -  Alkaline phosphatase ≥ 1.5 x ULN;

               -  Total bilirubin > 1.25 x ULN;

               -  eGFR < 60 mL/min/1.73m2.

          6. Pregnancy or lactation.

          7. Any vaccination within 14 days prior to mAb infusions, except for influenza vaccine.

          8. Receipt of another investigational product currently or within the past 12 weeks, or
             expected concurrent participation in another study in which investigational products
             will be administered.

          9. Receipt of any experimental HIV vaccine or anti-HIV monoclonal antibody therapy in the
             past.

         10. History of severe reaction to a vaccine or drug infusion or history of severe allergic
             reactions.

         11. Individuals with known hypersensitivity to any constituent of the investigational
             products.