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Phase 4 Study of Dolutegravir (DTG) in Russian Federation

Primary Purpose

Infection, Human Immunodeficiency Virus, HIV Infections

Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Dolutegravir 50 mg
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection, Human Immunodeficiency Virus focused on measuring Phase 4, Russian Federation, dolutegravir, long-term safety, Human Immunodeficiency Virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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complete an End of Study (EOS) visit for the originating protocol ING112276, ING113086, ING114915, ING111762, or be withdrawn from 200304 and attend withdrawal visit prior to transitioning to this study.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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIV positive subjects continuing DTG

Arm Description

HIV positive 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 LPV/RTV will be included in this study.

Outcomes

Primary Outcome Measures

Number of subjects with drug related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Drug related AE is defined as all untoward and unintended responses to an investigational medicinal product related to any dose administered. All AEs will be graded according to Division of AIDS (DAIDS) toxicity scale.
Number of subjects with abnormal hematology parameters
Hematology parameters will be evaluated and will be graded according to DAIDS toxicity scale.
Number of subjects with abnormal clinical chemistry parameters
Clinical chemistry parameters will be evaluated and will be graded according to DAIDS toxicity scale.
Number of subjects with abnormal urine parameters
Urine parameters will be evaluated and will be graded according to DAIDS toxicity scale.
Number of subjects with abnormal electrocardiogram (ECG)
The number of subjects with abnormal ECG results will be summarized.
Number of subjects with abnormal radiological scan
The number of subjects with abnormal radiological scan will be summarized.
Number of subjects with abnormal physical examination
The number of subjects with abnormal physical examination will be summarized
Number of subjects with abnormal blood pressure
The number of subjects with abnormal blood pressure will be summarized.
Number of subjects with abnormal heart rate
The number of subjects with abnormal heart rate will be summarized.
Number of subjects with abnormal temperature
The number of subjects with abnormal body temperature will be summarized.
Number of subjects with abnormal respiratory rate
The number of subjects with abnormal respiratory rate will be summarized.
Number of subjects receiving concomitant medications
All the concomitant medications that the subject will receive will be evaluated.
Number of subjects achieving HIV-1 ribonucleic acid (RNA) suppression < 50 copies per milliliter (c/mL)
Efficacy of DTG will be assessed at routine clinical practice based on the maintenance of HIV-1 RNA suppression at <50 c/mL.

Secondary Outcome Measures

Full Information

First Posted
October 13, 2017
Last Updated
January 31, 2019
Sponsor
ViiV Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT03314064
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 8, 2016 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Human Immunodeficiency Virus, HIV Infections
Keywords
Phase 4, Russian Federation, dolutegravir, long-term safety, Human Immunodeficiency Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
This is an open label, single group study where the eligible subjects will receive DTG 50 mg once daily.
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIV positive subjects continuing DTG
Arm Type
Experimental
Arm Description
HIV positive 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 LPV/RTV will be included in this study.
Intervention Type
Drug
Intervention Name(s)
Dolutegravir 50 mg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of subjects with drug related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
Drug related AE is defined as all untoward and unintended responses to an investigational medicinal product related to any dose administered. All AEs will be graded according to Division of AIDS (DAIDS) toxicity scale.
Time Frame
Up to 7 months approximately
Title
Number of subjects with abnormal hematology parameters
Description
Hematology parameters will be evaluated and will be graded according to DAIDS toxicity scale.
Time Frame
Up to 7 months approximately
Title
Number of subjects with abnormal clinical chemistry parameters
Description
Clinical chemistry parameters will be evaluated and will be graded according to DAIDS toxicity scale.
Time Frame
Up to 7 months approximately
Title
Number of subjects with abnormal urine parameters
Description
Urine parameters will be evaluated and will be graded according to DAIDS toxicity scale.
Time Frame
Up to 7 months approximately
Title
Number of subjects with abnormal electrocardiogram (ECG)
Description
The number of subjects with abnormal ECG results will be summarized.
Time Frame
Up to 7 months approximately
Title
Number of subjects with abnormal radiological scan
Description
The number of subjects with abnormal radiological scan will be summarized.
Time Frame
Up to 7 months approximately
Title
Number of subjects with abnormal physical examination
Description
The number of subjects with abnormal physical examination will be summarized
Time Frame
Up to 7 months approximately
Title
Number of subjects with abnormal blood pressure
Description
The number of subjects with abnormal blood pressure will be summarized.
Time Frame
Up to 7 months approximately
Title
Number of subjects with abnormal heart rate
Description
The number of subjects with abnormal heart rate will be summarized.
Time Frame
Up to 7 months approximately
Title
Number of subjects with abnormal temperature
Description
The number of subjects with abnormal body temperature will be summarized.
Time Frame
Up to 7 months approximately
Title
Number of subjects with abnormal respiratory rate
Description
The number of subjects with abnormal respiratory rate will be summarized.
Time Frame
Up to 7 months approximately
Title
Number of subjects receiving concomitant medications
Description
All the concomitant medications that the subject will receive will be evaluated.
Time Frame
Up to 7 months approximately
Title
Number of subjects achieving HIV-1 ribonucleic acid (RNA) suppression < 50 copies per milliliter (c/mL)
Description
Efficacy of DTG will be assessed at routine clinical practice based on the maintenance of HIV-1 RNA suppression at <50 c/mL.
Time Frame
Up to 7 months approximately

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
ViiV Healthcare
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Ekaterinburg
ZIP/Postal Code
620149
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Kazan
ZIP/Postal Code
420061
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Kemerovo
ZIP/Postal Code
650056
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Krasnodar
ZIP/Postal Code
350015
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
105275
Country
Russian Federation
Facility Name
GSK Investigational Site
City
N.Novgorod
ZIP/Postal Code
603005
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Orel
ZIP/Postal Code
302040
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Smolensk
ZIP/Postal Code
214006
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St. Petersburg
ZIP/Postal Code
190103
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St. Petersburg
ZIP/Postal Code
196645
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Toliyatti
ZIP/Postal Code
445846
Country
Russian Federation

12. IPD Sharing Statement

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Phase 4 Study of Dolutegravir (DTG) in Russian Federation

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