PREVAIL IV: Double-blind, Randomized, Two-phase, Placebo-controlled, Phase II Trial of GS-5734 to Assess the Antiviral Activity, Longer-term Clearance of Ebola Virus, and Safety in Male Ebola Survivors with Evidence of Ebola Virus Persistence in Semen NIAID Protocol Number: 16-I-N137 Version Number: 10.0 Date: May 13, 2019 Investigational New Drug (IND) Number: 130621 IND Sponsor: Office of Clinical Research Policy and Regulatory Operations (OCRPRO), Division of Clinical Research (DCR), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) Local Liberian Medical Officer: Ian Wachekwa, MD Safety Medical Officer John F. Kennedy Hospital 21 Street, Sinkor Monrovia, Liberia
[email protected] (t) +231880890907 Sponsor Medical Monitor: Alan Lifson, MD, MPH Professor, Division of Epidemiology and Community Health School of Public Health University of Minnesota 1300 S. Second St., Ste. 300 Minneapolis, MN 55454 (t) 612-626-9697 (f) 612-624-0315
[email protected] Pharmaceutical Support Provided by: Gilead Sciences, Inc. PREVAIL IV Version 10.0 13 May 2019 Conducted by: Liberia-US Joint Clinical Research Partnership also known as the Partnership for Research on Ebola Virus in Liberia (PREVAIL) Page 2 of 77 PREVAIL IV Version 10.0 13 May 2019 Key Roles NIH Principal Investigator: Elizabeth S. Higgs, MD, MIA, DTMH Division of Clinical Research, NIAID
[email protected] (c) +301-768-3947 skype: libby.higgs2 Liberian Principal Investigator: Dehkontee Gayedyu-Dennis, MD PREVAIL
[email protected] (t) +231-886-538-810