A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Part A:

      The purpose of this part of the study is to understand how the body's immune system responds
      to a new lab-made antibody against HIV. The study is looking to see if the way the antibody
      is given affects the immune response. The study will also look at whether the antibody is
      safe to give to people and does not make them too uncomfortable.

      Part B:

      The purpose of this part of the study is to understand how the body's immune system responds
      to lab-made antibodies against HIV when they are given in combination at different doses. The
      study also wants to see if the way the antibodies are given affects the immune response.
    

Detailed description: 
      The HIV Vaccine Trials Network (HVTN) and the HIV Prevention Trials Network (HPTN) are
      conducting this study to test a combination of different antibodies against HIV. HIV is the
      virus that causes AIDS. Antibodies are made by the body as one way to respond to or fight
      infection. Researchers can also make antibodies in laboratories and give them to people by
      infusions into a vein or under the skin.

      There are 2 parts of this study, Part A and Part B. About 15 people will take part in Part A
      of this study to test one study antibody. After early safety results from Part A are
      obtained, a decision will be made as to whether or not to do Part B of the study. Part B of
      the study would test a combination of 3 antibodies. If it is decided to move forward with
      Part B, 80 more people will join.
    

Intervention name(s): PGDM1400LS (5mg/kg, IV); PGDM1400LS (20mg/kg, IV); PGDM1400LS (20mg/kg, SC); PGDM1400LS (40mg/kg, IV); PGDM1400LS (40mg/kg, SC); PGDM1400LS (1.4g, IV); PGDM1400LS (1.4g, SC); VRC07-523LS (20mg/kg, IV); VRC07-523LS (20mg/kg, SC); VRC07-523LS (1.4g, IV); VRC07-523LS (1.4g, SC); VRC07-523LS (40mg/kg, IV); PGT121.414.LS (20mg/kg, IV); PGT121.414.LS (20mg/kg, SC); PGT121.414.LS (1.4g, IV); PGT121.414.LS (1.4g, SC); PGT121.414.LS (40mg/kg, IV)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5 mg/kg to be administered via IV infusion; 20 mg/kg to be administered via IV infusion; 20 mg/kg to be administered via SC infusion; 40 mg/kg to be administered via IV infusion; 40 mg/kg to be administered via SC infusion; 1.4gram to be administered via IV infusion; 1.4gram to be administered via SC infusion; VRC07-523LS 20mg/kg administered via IV infusion; VRC07-523LS 20mg/kg administered via SC infusion; VRC07-523LS 1.4g administered via IV infusion; VRC07-523LS 1.4g administered via SC infusion; VRC07-523LS 40mg/kg administered via IV infusion; PGT121.414.LS 20mg/kg administered via IV infusion; PGT121.414.LS 20mg/kg administered via SC infusion; PGT121.414.LS 1.4g administered via IV infusion; PGT121.414.LS 1.4g administered via SC infusion; PGT121.414.LS 40mg/kg administered via IV infusion
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention