Human Immunodeficiency Virus Clinical Trial
Official title:
An Open Label, Single Arm Study of the Safety and Antiretroviral Activity of Two Long-acting Broadly Neutralizing Antibodies Plus an IL-15 Superagonist in ART-treated Adults Living With HIV During Analytical Treatment Interruption
The proposed study is a phase 1, open label, single arm study to evaluate the safety and antiretroviral activity of the combination of two long-acting broadly neutralizing antibodies, 3BNC117-LS dosed once at 30 mg/kg and 10-1074-LS dosed once at 10 mg/kg, both intravenously (IV) at week 0, plus an IL-15 superagonist complex, N-803, dosed at 6 mcg/kg, subcutaneously (SC) at week 1 and then every 3 weeks for a total of 8 doses, in ART-treated adults living with HIV during analytical treatment interruption.
The proposed study is a phase 1, open label study of the safety and antiretroviral activity of the 3BNC117-LS plus 10-1074-LS broadly neutralizing antibody (bNAb) combination plus N-803, an IL-15 superagonist complex, in ART-treated individuals living with HIV during interruption of ART. Thirty-six eligible participants will be enrolled sequentially and will be assigned to Group A or Group B after Monogram PhenoSense Assay results become available: Group A - participants with 3BNC117 and 10-1074 IC90 less or equal to 1 mcg/mL and MPI greater or equal to 98% by the Monogram PhenoSense assay using PBMCs; Group B - all other participants, including participants from whom the PhenoSense Assay (PBMC) does not yield a result. Participants will discontinue ART on day 2 (2 days after the first antibody infusions) and will be followed for up to 72 weeks while off ART and for 12 weeks after ART is resumed. ;
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