SAFETY AND VIROLOGIC EFFECT OF A HUMAN MONOCLONAL ANTIBODY, VRC-HIVMAB060-00-AB (VRC01), WITH BROAD HIV-1 NEUTRALIZING ACTIVITY, ADMINISTERED INTRAVENOUSLY TO ADULTS DURING EARLY ACUTE HIV INFECTION
This is a multi-center study conducted in three East African countries (Tanzania, Kenya, Uganda) and Thailand. The participants obtained from RV 217 cohort.The study product (VRC01) is a broadly neutralizing human mAb targeted against the HIV-1 CD4 binding site. It was developed by the VRC/NIAID/NIH. VRC01 is of the Immunoglobulin G1 (IgG1) subtype and is highly somatically mutated from its germ-line precursor. The heavy chain CDR3 region is 14 amino acids long, which is an average length relative to natural antibodies, and the glycosylation pattern is derived from its production in a Chinese Hamster Ovary (CHO) mammalian cell line.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS),
National Institutes of Health (NIH) Bethesda, Maryland
STUDY DURATION: Total study duration of 25 weeks.
STUDY OBJECTIVES
Primary objectives
1. Safety of VRC01 in acutely HIV-infected viremic individuals
2. Impact of VRC01 on plasma viremia in each mAb arm compared to the ART plus
placebo control at day 7 (+/- 1 day)
Secondary objectives
1. Impact of VRC01 on viral dynamics in plasma over the course of 24 weeks.
2. Impact of VRC01 on HIV reservoir measures in peripheral blood mononuclear cells and plasma
3. Impact of VRC01 on clinical outcomes/characteristics of AHI
4. Impact of VRC01 on CD4 + T cell count
5. Pharmacokinetics of VRC01 in AHI in peripheral blood
Exploratory objectives
1. Impact of VRC01 on reservoir measures in CSF, mucosal, and tissue compartments
2. Comparison of peripheral blood reservoir measures to those in the CSF, mucosal and
tissue compartments
3. Impact of VRC01 on reservoir measures in T cell subsets
4. Pharmacokinetics of VRC01 in CSF and mucosal compartments
5. Anti-VRC01 antibody detection
6. Impact of VRC01 on immune responses and activation
7. Effect of VRC01 on viral sequence, phenotype, and evolution
8. Predictors of favorable viral dynamics, immune responses, and reservoir seeding
9. Impact of VRC01 on neuropsychological testing outcomes
Preliminary Findings: The study not yet started.
Team
PI: Joe T. Mwakisisile
Study Coordinator:Dr. Joseph Hidda
Study Doctor Dr. Sylvia Urio
Other Investigators: Dr.Maganga, Arne Kroidl ,Michael Hoelscher
Laboratory Manager: Cornelia Luer, Mkunde Chahage
Data Manager Unity: Dickens Kowuor
Study Nurses: Vumilia Kaduma, IreneJoseph, Amina Abbu
Laboratory Team: Exaud Gomuo, Donata Wililo and Last Mwaipopo
