VRC 601: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC HIVMAB060-00-AB (VRC01), With Broad HIV-1 Neutralizing Activity, Administered Intravenously or Subcutaneously to HIV-Infected...
Condition: HIV-1 Infection; Neutralizing Antibody; Monoclonal Antibody; Viral Load; HIV Antibodies
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first clinical trial of the VRC-HIVMAB060-00-AB (VRC01) monoclonal antibody.
      VRC01 is a broadly neutralizing antibody directed against HIV. This is a dose-escalation
      study to examine safety, tolerability, dose and pharmacokinetics of VRC01. The hypothesis is
      that VRC01 will be safe for administration to HIV-1 infected adults by the intravenous (IV)
      and subcutaneous (SC) routes and will not elicit hypersensitivity reactions. Samples will be
      collected to learn if VRC01 is detectable in mucosal secretions and blood of participants and
      how long VRC01 can be detected in the blood after it is given.

      Between 15 and 25 HIV-1 infected adults, ages 18-70 years will be enrolled. There are 4 dose
      escalation groups for IV administration; the doses are 1 mg/kg, 5 mg/kg, 20 mg/kg and 40
      mg/kg. There is 1 group for SC administration at 5 mg/kg. Each group is expected to include
      at least 3 participants. Each participant will receive two infusions of VRC01 with about 1
      month between doses. Infusions are administered in an inpatient unit and an overnight stay at
      the NIH Clinical Center is required. No more than one subject per day per group will receive
      a first infusion of the VRC01 product by the IV route and no more than one subject per week
      will receive a first infusion of the product by the SC route. Study participation lasts for
      24 weeks. Participant health and effect on CD4 count and HIV viral load will be monitored.
      Samples will be collected and stored for research purposes.

      ...
    

Detailed description: 
      This is the first clinical trial of the VRC-HIVMAB060-00-AB (VRC01) monoclonal antibody.
      VRC01 is a broadly neutralizing antibody directed against HIV. This is a dose-escalation
      study to examine safety, tolerability, dose and pharmacokinetics of VRC01. The hypothesis is
      that VRC 01 will be safe for administration to HIV-1- infected adults by the intravenous (IV)
      and subcutaneous (SC) routes and will not elicit hypersensitivity reactions. Samples will be
      collected to learn if VRC01 is detectable in mucosal secretions and blood of participants and
      how long VRC01 can be detected in the blood after it is given.

      Up to 30 HIV-1 infected adults will be enrolled. Adult 18-60 years old will participate in
      the dose escalation part of the study. There are 4 dose escalation groups for IV
      administration; the doses are 1 mg/kg, 5 mg/kg, 20 mg/kg and 40 mg/kg. There is 1 group for
      SC administration at 5 mg/kg. Each dose escalation group is expected to include at least 3
      participants. Each participant during the dose escalation part of the study will receive two
      infusions of VRC01 with about 1 month between doses, with infusions administered in an
      inpatient unit and an overnight stay at the NIH Clinical Center required. No more than one
      subject per day per group will receive a first infusion of the VRC01 product by the IV route
      and no more than one subject per week will receive a first infusion of the product by the SC
      route. Study participation lasts for 24 weeks for participants who receive two doses. After
      the dose escalation is completed, about 10 HIV-infected adults, ages 18-70 years old, with
      detectable viral load will be enrolled to receive one dose of VRC01 at 40 mg/kg IV with
      follow-up for 12 weeks. Participant health and effect on CD4 count and HIV viral load will be
      monitored. Samples will be collected and stored for research purposes.
    

Intervention name(s): VRC-HIVMAB060-00-AB
Intervention type(s): Biological
Intervention description(s): VRC01 Human Monoclonal Antibody
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-1 Viral Load; CD4 Count; Antiviral; HIV-1 Infection; Broadly Neutralizing Antibody