456
Participants
Start Date
March 28, 2019
Primary Completion Date
February 12, 2024
Study Completion Date
August 30, 2026
Standard of Care (SOC) Oral ART
SOC oral ART regimen must include at least 3 drugs with 2 or more drugs predicted to be fully active, including a boosted protease inhibitor (PI) and/or an integrase strand transfer inhibitor (INSTI)
Oral RPV
RPV 25 mg tablets
Oral CAB
CAB 30 mg tablets
RPV-LA Loading Dose
900 mg administered as one 3 mL (900 mg) intramuscular injection in the gluteal muscle
CAB-LA Loading Dose
600 mg administered as one 3 mL (600 mg) intramuscular injection in the gluteal muscle
RPV-LA Maintenance Dose
600 mg administered as one 2 mL (600 mg) intramuscular injection in the gluteal muscle
CAB-LA Maintenance Dose
400 mg administered as one 2 mL (400 mg) intramuscular injection in the gluteal muscle
Weill Cornell Chelsea CRS, New York
Weill Cornell Uptown CRS, New York
Jacobi Med. Ctr. Bronx NICHD CRS, The Bronx
SUNY Stony Brook NICHD CRS, Stony Brook
University of Pittsburgh CRS, Pittsburgh
Penn Therapeutics, CRS, Philadelphia
Johns Hopkins University CRS, Baltimore
Greensboro CRS, Greensboro
Chapel Hill CRS, Chapel Hill
Univ. of Florida Jacksonville NICHD CRS, Jacksonville
Alabama CRS, Birmingham
Vanderbilt Therapeutics (VT) CRS, Nashville
Ohio State University CRS, Columbus
Case Clinical Research Site, Cleveland
Cincinnati Clinical Research Site, Cincinnati
Northwestern University CRS, Chicago
Rush University CRS, Chicago
Houston AIDS Research Team CRS, Houston
University of Colorado Hospital CRS, Aurora
UCLA CARE Center CRS, Los Angeles
Harbor-UCLA CRS, Torrance
UCSD Antiviral Research Center CRS, San Diego
Ucsf Hiv/Aids Crs, San Francisco
University of Southern California CRS, Los Angeles
The Ponce de Leon Center CRS, Atlanta
Massachusetts General Hospital CRS (MGH CRS), Boston
Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS, Boston
Washington University Therapeutics (WT) CRS, St Louis
New Jersey Medical School Clinical Research Center CRS, Newark
Columbia P&S CRS, New York
The Miriam Hospital Clinical Research Site (TMH CRS) CRS, Providence
University of Washington AIDS CRS, Seattle
Puerto Rico AIDS Clinical Trials Unit CRS, San Juan
Collaborators (1)
ViiV Healthcare
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH