123
Participants
Start Date
November 27, 2017
Primary Completion Date
March 8, 2021
Study Completion Date
March 9, 2022
Islatravir
Islatravir at 0.25 mg, 0.75 mg or 2.25 mg is orally administered QD in capsule form for up to 52 weeks. After Week 60 a selected open label dose may be administered.
Placebo to Islatravir
Placebo to islatravir is orally administered QD in capsule form for up to 52 weeks
Doravirine
Doravirine 100 mg is orally administered QD in tablet form for up to 144 weeks
Placebo to Doravirine
Placebo to Doravirine is orally administered QD in tablet form for up to 52 weeks
Lamivudine
Lamivudine 300 mg is orally administered QD in tablet form for up to 52 weeks
Placebo to Lamivudine
Placebo to Lamivudine is orally administered QD in tablet form for up to 52 weeks
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate
Fixed dose combination of 100 mg doravirine + 300 mg lamivudine + 300 mg tenofovir disoproxil fumarate is orally administered QD in tablet form for up to 144 weeks.
Placebo to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate
Placebo to doravirine/lamivudine/tenofovir disoproxil fumarate is orally administered QD in tablet form for up to 52 weeks
Doravirine/Islatravir
Fixed dose combination of islatravir 0.75 mg/doravirine 100 mg orally administered QD in tablet form for 48 weeks
Whitman Walker Clinic ( Site 0108), Washington D.C.
Orlando Immunology Center (OIC) ( Site 0105), Orlando
Northstar Medical Center ( Site 0102), Chicago
Kansas City CARE Clinic ( Site 0106), Kansas City
North Texas Infectious Diseases Consultants, PA ( Site 0103), Dallas
Tarrant County Infectious Disease Associates ( Site 0112), Fort Worth
The Crofoot Research Center, Inc. ( Site 0118), Houston
Saint Hope Foundation, Inc. ( Site 0116), Bellaire
Pueblo Family Physicians ( Site 0119), Phoenix
University California / Davis ( Site 0101), Sacramento
Clinica Arauco Salud ( Site 0200), Santiago
Biomedica Research Group ( Site 0202), Santiago
Hospital Dr. Hernan Henriquez Aravena ( Site 0203), Temuco
Hopital Avicenne ( Site 2302), Bobigny
Hopital Saint-Andre ( Site 2307), Bordeaux
CHU Hotel Dieu ( Site 2308), Nantes
CHU de Nice Hopital Archet 1 ( Site 2303), Nice
Hopital Bichat - Claude Bernard ( Site 2309), Paris
Hopital Pitie Salpetriere ( Site 2305), Paris
Hopital Saint Louis ( Site 2306), Paris
Centre Hospitalier de Tourcoing ( Site 2301), Tourcoing
Brighton and Sussex University Hospitals NHS Trust ( Site 2105), Brighton
Chelsea and Westminster Hospital ( Site 2101), London
Royal London Hospital ( Site 2103), London
The Royal Free London NHS Foundation Trust ( Site 2102), London
North Manchester General Hospital ( Site 2104), Manchester
Merck Sharp & Dohme LLC
INDUSTRY