Clinical trial NCT03314064: Phase 4 Study of Dolutegravir (DTG) in Russian Federation
Official title: Long-term Safety of Subjects Continuing Dolutegravir After Participation in Clinical Studies of Dolutegravir in Russian Federation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infection, Human Immunodeficiency Virus
HIV Infections
Keywords: Phase 4
Russian Federation
dolutegravir
long-term safety
Human Immunodeficiency Virus
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
First posted: 2017-10-19
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open label, single group study where the eligible subjects will receive DTG 50 mg once daily.
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

* 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complete an End of Study (EOS) visit for the originating protocol ING112276, ING113086, ING114915, ING111762, or be withdrawn from 200304 and attend withdrawal visit prior to transitioning to this study.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 Criteria:

* 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.

Primary outcomes:
measure: Number of subjects with drug related Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 7 months approximately
measure: Number of subjects with abnormal hematology parameters
timeFrame: Up to 7 months approximately
measure: Number of subjects with abnormal clinical chemistry parameters
timeFrame: Up to 7 months approximately
measure: Number of subjects with abnormal urine parameters
timeFrame: Up to 7 months approximately
measure: Number of subjects with abnormal electrocardiogram (ECG)
timeFrame: Up to 7 months approximately
measure: Number of subjects with abnormal radiological scan
timeFrame: Up to 7 months approximately
measure: Number of subjects with abnormal physical examination
timeFrame: Up to 7 months approximately
measure: Number of subjects with abnormal blood pressure
timeFrame: Up to 7 months approximately
measure: Number of subjects with abnormal heart rate
timeFrame: Up to 7 months approximately
measure: Number of subjects with abnormal temperature
timeFrame: Up to 7 months approximately
measure: Number of subjects with abnormal respiratory rate
timeFrame: Up to 7 months approximately
measure: Number of subjects receiving concomitant medications
timeFrame: Up to 7 months approximately
measure: Number of subjects achieving HIV-1 ribonucleic acid (RNA) suppression < 50 copies per milliliter (c/mL)
timeFrame: Up to 7 months approximately
Secondary outcomes:
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Kazan
country: Russian Federation
facility: GSK Investigational Site
city: Kemerovo
country: Russian Federation
facility: GSK Investigational Site
city: Krasnodar
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: N.Novgorod
country: Russian Federation
facility: GSK Investigational Site
city: Orel
country: Russian Federation
facility: GSK Investigational Site
city: Smolensk
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Toliyatti
country: Russian Federation
facility: GSK Investigational Site
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: