Trials / Completed
CompletedNCT03314064
Phase 4 Study of Dolutegravir (DTG) in Russian Federation
Long-term Safety of Subjects Continuing Dolutegravir After Participation in Clinical Studies of Dolutegravir in Russian Federation
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- ViiV Healthcare · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dolutegravir 50 mg | DTG is an integrase inhibitor that has been developed for ART of HIV-infection in combination with other antiretrovirals. DTG will be available as 50 mg tablets to be administered once daily. |
Timeline
- Start date
- 2016-12-08
- Primary completion
- 2018-10-01
- Completion
- 2018-10-01
- First posted
- 2017-10-19
- Last updated
- 2019-02-04
Locations
11 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT03314064. Inclusion in this directory is not an endorsement.