Status:
COMPLETED
Phase 4 Study of Dolutegravir (DTG) in Russian Federation
Lead Sponsor:
ViiV Healthcare
Conditions:
Infection, Human Immunodeficiency Virus
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 a...
Eligibility Criteria
Inclusion
- The subject must complete an End of Study (EOS) visit for the originating protocol ING112276, ING113086, ING114915, ING111762, or be withdrawn from 200304 and attend withdrawal visit prior to transitioning to this study.
- Documented evidence of plasma HIV-1 RNA measurement \<50 c/mL at the EOS visit in ING112276, ING113086, ING114915, ING111762, 200304 (for subjects receiving DTG ) and \<400 c/mL for subjects prior receiving LPV/RTV in 200304.
- Based on medical assessment by the subject's Principal Investigator, the subject continues to derive clinical benefit from treatment with DTG as part of combination antiretroviral therapy (cART) and demonstrates stable virologic success. For subjects, currently receiving LPV/RTV and finishing their participation in 200304, possibility to derive clinical benefit from treatment with DTG is assessed by Principal Investigator following recommendation of Independent Data Monitoring Committee (IDMC).
- Subjects must be capable of giving signed informed consent to participate in this study.
Exclusion
- Subjects not currently enrolled in clinical study ING112276, ING113086, ING114915, ING111762, 200304 are not eligible for this study.
- Subjects for whom confirmed virologic withdrawal criteria were met in ING112276, ING113086, ING114915, ING111762, 200304 are not eligible.
- In addition to the above mentioned criteria, investigator/physician must confirm that the subject has no prohibited clinical condition (other medicines or other health conditions, such as hepatic or renal contra-indications). Further, all women of child bearing potential must be cautioned that DTG is not approved for use in pregnancy, and be advised that birth control measures should be in place while taking DTG. Subjects who were permanently discontinued from DTG in the previous study due to intolerance must not be included in this study.
Key Trial Info
Start Date :
December 8 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03314064
Start Date
December 8 2016
End Date
October 1 2018
Last Update
February 4 2019
Active Locations (11)
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1
GSK Investigational Site
Kazan', Russia, 420061
2
GSK Investigational Site
Kemerovo, Russia, 650056
3
GSK Investigational Site
Krasnodar, Russia, 350015
4
GSK Investigational Site
Moscow, Russia, 105275