Evaluating the Safety and Drug Levels of an Antibody Against HIV in Healthy, HIV-Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Antibodies are natural proteins that the body makes to fight infections. Antibodies can also
      be manufactured like a drug and infused or injected into the body to prevent or treat a
      disease. The purpose of this study is to test the safety of and the body's response to an
      antibody against HIV in healthy, HIV-uninfected adults.
    

Detailed description: 
      The purpose of this study is to evaluate the safety, tolerability, and drug levels of five
      different schedules for the intravenous (IV) and subcutaneous (SC) administration of a human
      monoclonal antibody (VRC-HIVMAB060-00-AB [VRC01]) against HIV in healthy, HIV-uninfected
      adults.

      The study will enroll 88 healthy, HIV-uninfected adults aged 18 to 50 years.

      This study will enroll participants in 5 groups. Groups 1-3 will enroll simultaneously.
      Groups 1 and 2 will be randomized together but not blinded, while Group 3 will be randomized
      separately and will be blinded. With the implementation of Version 2.0, Groups 4 and 5 will
      be randomized together and will enroll simultaneously. Each group will have a different
      schedule of clinic visits and receive different doses of VRC01 or placebo for VRC01.
      Participants will attend 8 months of scheduled clinic visits.

      Participants in Group 1 will receive an IV infusion of VRC01 on Days 0, 28, 56, 84, 112, and
      140. Participants in Group 2 will receive an IV infusion of VRC01 on Days 0, 56, and 112.
      Participants in Group 3 will receive an IV infusion of VRC01 or IV placebo for VRC01 on Day
      0, followed by SC injections of VRC01 or SC placebo for VRC01 on Days 14, 28, 42, 56, 70, 84,
      98, 112, 126, 140, and 154. Participants in Groups 4 and 5 will receive an IV infusion of
      VRC01 (each group will receive a different dose) on Days 0, 56, and 112.

      Participants will remain in the clinic for about an hour after receiving the infusions and
      injections for observation and monitoring. Participants in Group 3 who have no problems with
      the first SC injection will have to wait in the clinic for only a half an hour after the rest
      of the SC injections.

      At study entry, participants will give a medical history; undergo a physical exam, blood
      collection, and urine collection; and receive HIV risk reduction counseling. At follow-up
      visits, participants will undergo a brief physical exam and blood collection, receive HIV
      risk reduction counseling, and be asked questions about their health and their experience
      participating in the study. At all visits, participants who were born female will have a
      pregnancy test. At select study visits, saliva, rectal, and semen or cervical secretion
      samples will be collected from participants who consent to collection of these samples.
    

Intervention name(s): VRC01; SC placebo for VRC01; IV placebo for VRC01
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Administered IV in 100 mL of normal saline (Sodium Chloride for Injection 0.9%, USP) or administered SC by needle and syringe injection.; Sterile, buffered aqueous solution of 25 mM Sodium Citrate, 50 mM Sodium Chloride, 150 mM L-Arginine Hydrochloride, 10% Dextran 40, and 0.005% Polysorbate 80 at pH 5.8 administered SC by needle and syringe injection; Sodium Chloride for Injection 0.9%, USP administered IV in 100 mL of normal saline (Sodium Chloride for Injection 0.9%, USP)
Other intervention name(s): Human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB; SC placebo for VRC-PLAMAB068-00-AB; Sodium Chloride for Injection 0.9%, USP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention