Safety and Antiviral Activity of VRC01 in HIV-Infected Adults During Treatment Interruption

Phase 1, open-label, single-arm trial of VRC01 in human immunodeficiency virus infection (HIV), sponsored by National Institute of Allergy and Infectious Diseases. Primary endpoints: Percentage of Participants Who Experienced a Grade 3 or Higher Systemic Adverse Event That is Possibly, Probably, or Definitely Related to the Administration of the VRC01 Antibody at Week 21 and Percentage of Participants Who Had a Confirmed HIV-1 RNA Greater Than or Equal to 200 Copies/mL at Week 8 of the Analytical Treatment Interruption (ATI) or Indication to Re-initiate ART Prior to… Started Aug 2015; status: completed.