Phase 4 Study of Dolutegravir (DTG) in Russian Federation

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Immunologic Deficiency Syndromes
Infection
Infection, Human Immunodeficiency Virus

Clinical Trial Details

NCT number	NCT03314064
Study type	Interventional
Source	ViiV Healthcare
Contact
Status	Completed
Phase	Phase 4
Start date	December 8, 2016
Completion date	October 1, 2018

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