Safety and Virologic Effect of a Human Monoclonal Antibody, VRC-HIVMAB080-00-AB (VRC01LS), With Broad HIV-1 Neutralizing Activity, Administered Intravenously to HIV-Infected Adults
The human body uses antibodies as one way to help fight infection. VRC01LS is an antibody directed against the HIV virus. Researchers want to see if it is safe and well tolerated. They will study the amount of VRC01LS in the body and how it changes over time. They will check to see if people who get VRC01LS develop an immune response to it.
To see if VRC01LS is safe and well tolerated.
Adults ages 18 70 who are HIV infected but otherwise healthy. Females who are able to get pregnant must be willing to use birth control during the study.
Participants will be screened in another protocol.
Participants will get the study drug one time, by IV infusion. A needle will guide a thin tube into a vein. The study drug mixed with salt water will be dripped into the vein over about 30 minutes.
Participants will be monitored for 30 minutes after the infusion.
Blood samples will be taken at the following times:
Once before the infusion
5 times in the 4 hours after the infusion
1 time 24 hours after infusion. Some participants may have 3 optional blood draws in the time period between 4 and 24 hours.
For 3 days after the infusion, participants will write their temperature and symptoms in a diary.
There will be a total of 23 study visits over 48 weeks. Ten visits will be in the first 4 weeks. At all visits, participants will answer health questions and give blood samples.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||VRC 607: A Phase 1, Single Dose Study of the Safety and Virologic Effect of a Human MonoclonalAntibody, VRC-HIVMAB080-00-AB (VRC01LS), With Broad HIV-1 Neutralizing Activity, Administered Intravenously to HIV-Infected Adults.|
- To evaluate the safety and tolerability of VRC01LS administered at 40 mg/kg IV to HIV-1 infected viremic adults. [ Time Frame: Through 48 weeks of study participation. ]
- To evaluate the pharmacokinetics of VRC01LS at 40 mg/kg IV. [ Time Frame: Through the first 48 weeks post administration. ]
- To evaluate the effect on CD4 count and viral load. [ Time Frame: Through week 48. ]
- To determine whether anti-drug antibody (ADA) to VRC01LS can bedetected. [ Time Frame: Post administration ]
|Study Start Date:||July 11, 2016|
|Estimated Study Completion Date:||August 31, 2018|
|Estimated Primary Completion Date:||March 31, 2018 (Final data collection date for primary outcome measure)|
40 mg/kg IV
Biological: VRC-HIVMAB080-00-AB (VRC01LS)
VRC01LS is an investigational human monoclonal antibody targeted to the CD4 binding site of HIV-1. VRC01LS is a modification of the VRC01 monoclonal antibody with the addition of the "LS".
VRC 607: A Phase 1, Single Dose Study of the Safety and Virologic Effect of a Human Monoclonal Antibody, VRC-HIVMAB080-00-AB (VRC01LS), with Broad HIV-1 Neutralizing Activity, Administered Intravenously to HIV-Infected Adults.
This is the first study of the VRC-HIVMAB080-00-AB (VRC01LS) monoclonal antibody (MAb) in HIV-infected viremic adults. It is a study to examine safety, tolerability, pharmacokinetics (PK) and virologic impact of VRC01LS. The primary hypothesis is that VRC01LS is safe for intravenous administration to HIV-1-infected adults and will not elicit hypersensitivity reactions. The secondary hypothesis is that VRC01LS will be detectable in human sera with a definable half-life.
VRC-HIVMAB080-00-AB (VRC01LS) is a human MAb targeted to the CD4 binding site of HIV-1. VRC01LS is a modification of the VRC01 MAb (which has been shown to be safe and to have antiviral activity in human studies) with the addition of the LS , a 2-amino acid mutation designed to improve the half-life of the antibody. There are no changes to the Fab binding sites. It was developed and manufactured by VRC/NIAID/NIH under cGMP at the VRC Vaccine Pilot Plant operated under contract by the Vaccine Clinical Materials Program (VCMP), Leidos Biomedical Research, Inc., Frederick, MD. Vials are provided at 100 mg/mL.
HIV-1-infected viremic adults; 18-70 years of age.
This is an open-label, single dose study to assess VRC01LS administered at 40 mg/kg IV in HIVinfected viremic subjects. Safety lab samples, HIV viral load, CD4 count, PK samples and blood samples for human anti-VRC01LS antibody detection will be drawn at baseline and intervals throughout the study. Subjects will keep a daily diary of reactogenicity symptoms for the 3 days after
study product administration and will be queried at each study visit for adverse events.
VRC 607 Study Schema:
Subjects-10 (*The expected enrollment is 10 subjects. Up to 20 subjects may be enrolled in
the event that there are subjects who do not complete the sampling schedule, if additional PK evaluations are needed, or if additional subjects are needed for safety evaluations)
Administration Schedule-Day 0; 40 mg/kg IV
Study Duration: Subjects will be followed for 48 weeks after the study product administration.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02840474
|Contact: VRC Clinic||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: VRC Clinic 301-451-8715 email@example.com|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104-6056|
|Principal Investigator:||Grace L Chen, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|