Phase 4 Study of Dolutegravir (DTG) in Russian Federation
Status:
Completed
Trial end date:
2018-10-01
Target enrollment:
Participant gender:
Summary
DTG 50 milligram (mg) tablet was approved for marketing in Russian Federation; however, DTG
is not currently available for subjects at Acquired Immune Deficiency Syndrome (AIDS) Centers
as it is not available for order and supply via Federal program. This study is an open-label
study which will include subjects, who complete taking DTG in studies ING112276, ING113086,
ING114915, ING111762, and those subjects who end participation in study 200304 in which they
received either DTG or lopinavir/ritonavir (LPV/RTV). DTG will be supplied at a dose of 50 mg
once daily to eligible subjects until the subject stops taking DTG or transitions to
commercial supply of DTG when available at AIDS Centers via the Federal program. The
objective of this study is to bridge the gap between the closure of ING112276, ING113086,
ING114915, ING111762 or end of subject's participation in 200304 and the actual availability
of commercial DTG at AIDS Centers via Federal program for human immunodeficiency
(HIV)-1-infected adult subjects in Russian Federation. The study will also investigate
long-term safety of DTG for subjects continuing DTG in Russian Federation.