HIV-1 Infection Clinical Trial
Official title:
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 Adults
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.
...
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.
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