44
Participants
Start Date
May 30, 2014
Primary Completion Date
February 28, 2017
Study Completion Date
May 9, 2017
Sofosbuvir
Participants received one 400 mg tablet of sofosbuvir (SOF) orally every morning with food
Ribavirin
Participants received weight-based ribavirin RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.
Ledipasvir/Sofosbuvir
Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of Ledipasvir (LDV) and 400 mg of SOF.
7804 Weill Cornell Chelsea CRS, New York
7803 Weill Cornell Upton CRS, New York
6201 Penn Therapeutics CRS, Philadelphia
Whitman Walker Health CRS (31791), Washington D.C.
2701 Northwestern University CRS, Chicago
Rush Univ. Med. Ctr. ACTG CRS (2702), Chicago
31443 Trinity Health and Wellness Center CRS, Dallas
31473 Houston AIDS Research Team (HART) CRS, Houston
701 University of California, San Diego AntiViral Research Center CRS, San Diego
801 University of California, San Francisco HIV/AIDS CRS, San Francisco
101 Massachusetts General Hospital (MGH) CRS, Boston
2401 Cincinnati CRS, Cincinnati
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK