Who is sponsoring NCT03314064?

NCT03314064 is sponsored by ViiV Healthcare.

What drugs are being tested in NCT03314064?

Interventions in NCT03314064: Dolutegravir 50 mg.

What condition does NCT03314064 study?

NCT03314064 studies Infection, Human Immunodeficiency Virus, HIV Infections.

Is NCT03314064 still recruiting?

NCT03314064 is currently completed. Last updated 4 February 2019.

Last reviewed 2019-02-04 · How we verify

NCT03314064

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 4 Study of Dolutegravir (DTG) in Russian Federation

Completed Phase 4 Last updated 4 February 2019

What this trial tests

Phase 4 trial testing Dolutegravir 50 mg in Infection, Human Immunodeficiency Virus in 43 participants. Completed in 1 October 2018.

Timeline

8 December 2016

Primary endpoint
1 October 2018

1 October 2018

Quick facts

Lead sponsor	ViiV Healthcare
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	43
Start date	8 December 2016
Primary completion	1 October 2018
Estimated completion	1 October 2018
Sites	11 locations across Russia

Drugs / interventions tested

Dolutegravir 50 mg — full drug profile →

Conditions studied

Infection, Human Immunodeficiency Virus — all drugs for Infection, Human Immunodeficiency Virus →
HIV Infections — all drugs for HIV Infections →

Sponsor

ViiV Healthcare — full company profile →

Who can join

18 and older, any sex, with Infection, Human Immunodeficiency Virus or HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Dolutegravir 50 mg

Trials testing the same drug.

NCT03851588 — Standard Versus Double Dose Dolutegravir in Patients With HIV-associated Tuberculosis · Phase 2 · completed
NCT03991013 — Tenofovir-lamivudine-dolutegravir Combination as Second-line ART: a Randomised Controlled Trial · Phase 2 · completed
NCT03360682 — Clinical Trial to Evaluate the Efficacy, Pharmacokinetics (PK) Interactions and Safety of Dolutegravir Plus 2 Nucleoside · Phase 4 · completed
NCT01837277 — Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS Patients · Phase 2, PHASE3 · completed
NCT03224338 — Dolutegravir Plus 2 NRTIs, in Treatment-Naïve HIV-2 Infected Subjects · Phase 2 · completed

Other recruiting trials for Infection, Human Immunodeficiency Virus

Currently open trials in the same condition.

NCT02951052 — Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpiv · Phase 3 · active not recruiting

Other ViiV Healthcare trials

Trials by the same sponsor.

NCT07393659 — A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative · Phase 3 · not yet recruiting
NCT07525544 — A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants · Phase 1 · not yet recruiting
NCT07275606 — A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1 · Phase 1, PHASE2 · not yet recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
NCT07053384 — A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Vir · Phase 1 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03314064 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ViiV Healthcare
Last refreshed: 4 February 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03314064.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing