A5378: Safety & Virologic Effect of HIV-1 Specific Broadly Neutralizing Human MAbs (VRC01LS&VRC07523LS)

VRC 607/ACTG A5378: A Phase I, Single-Dose Study of the Safety and Virologic Effect of an HIV-1-Specific Broadly Neutralizing Human Monoclonal Antibody, VRC-HIVMAB080-00-AB (VRC01LS) or VRC-HIVMAB075-00-AB (VRC07-523LS), Administered Intravenously to HIV-Infected Adults

Study Description
In this study, two experimental products “VRC01LS” and “VRC07-523LS” will be given by intravenous (IV) infusion. VRC01LS and VRC07-523LS are antibodies directed against the HIV virus. Monoclonal antibodies (mAbs) are laboratory-produced molecules that serve as substitute antibodies, and can enhance or mimic the immune system's attack on HIV. The mAb used in the study targets the specific HIV-1 binding site, which the virus uses to attach to cells of the immune system.

Part A of this study was completed in 2017 by enrolling and infusing VRC01LS to seven patients. In Part B, 7–10 people will receive VRC07-523LS. The two antibodies will not be given together to any patients in this study.

Why is this study being done?
The study will see if the modified mAbs are safe and find out how a participant’s body will respond to them.
The study will measure the amount of the antibody in the body over time, and will also check how CD4 and HIV viral load levels change during the study.

Who can join?
HIV-1-infected individuals between the ages of 18 and 70 who:

  • Have not yet started on antiretroviral therapy
  • Have an HIV viral load between 500 and 100,000 copies
  • Have a current CD4 count greater than 350 cells
  • Do not have active hepatitis B or C

What do I need to do in the study?
The VRC07-523LS antibody will be infused using an IV in one of your arms. The antibody infusion process will take about 30 minutes. Participants will need to remain in the clinic for a minimum of 4 hours after the IV infusion is complete to collect blood at specified times before and after the infusion.

Participants will be given a “Diary Card” on which to record their temperature and any other symptoms/side effects they experience daily for 3 days after getting the antibody.

All participants will be followed in the study for up to 48 weeks after antibody administration. The study will include a total of 23 clinic visits per person over a period of about 11 months.

What treatments or drugs are involved with this study?
The VRC07-523LS will be provided through the study. HIV medications will not be supplied through this study. Participants will be strongly encouraged to start HIV treatment, under the direction of their HIV provider, 14 days after the infusion.

 

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