3BNC117-LS First-in-Human Phase 1 Study

Inclusion criteria

• . Males and females, age 18 to 65
• . Amenable to HIV risk reduction counseling and agrees to maintain behavior consistent with low risk of HIV exposure.
• . If sexually active male or female, and participating in sexual activity that could lead to pregnancy, 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 until seven months after 3BNC117-LS infusion, and agrees to safer sex counseling at each visit.
• . Males and females, age 18 to 65.
• . HIV-1 infection confirmed by two laboratory assays.
• . HIV-infected individuals off ART for at least 8 weeks with HIV-1 plasma RNA levels \< 100,000 copies/ml by standard assays (ART-naïve or off ART due to intolerance or by choice), or on ART with HIV-1 plasma RNA levels \< 20 copies/ml. HIV-1 RNA levels should be measured on 2 occasions, at least 1 week apart. At least one measurement must be performed within 49 days prior to enrollment (day 0). Group 2D will only enroll HIV-infected individuals on ART.
• . Current CD4+ T cell count \> 300 cells/μl.
• . 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 until seven months after 3BNC117-LS infusion, and agrees to safer sex counseling at each visit.