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Infection, Human Immunodeficiency VirusPhase 4NCT03314064

Phase 4 Study of Dolutegravir (DTG) in Russian Federation

A Phase 4 study testing Dolutegravir 50 mg in people with Infection, Human Immunodeficiency Virus and HIV Infections, run by ViiV Healthcare at 11 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dolutegravir 50 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
11 sitesRussia
Study dates
8 Dec 2016to 1 Oct 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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complete an End of Study (EOS) visit for the originating protocol ING112276, ING113086, ING114915, ING111762, or be withdrawn from 200304 and attend withdrawal visit prior to transitioning to this study.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

Who cannot join

  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Russia11 sites

  • GSK Investigational Site

    Kazan', 420061

  • GSK Investigational Site

    Kemerovo, 650056

  • GSK Investigational Site

    Krasnodar, 350015

  • GSK Investigational Site

    Moscow, 105275

  • GSK Investigational Site

    N.Novgorod, 603005

  • GSK Investigational Site

    Oryol, 302040

  • GSK Investigational Site

    Saint Petersburg, 190103

  • GSK Investigational Site

    Saint Petersburg, 196645

  • GSK Investigational Site

    Smolensk, 214006

  • GSK Investigational Site

    Toliyatti, 445846

  • GSK Investigational Site

    Yekaterinburg, 620149

Other trials in Russia

About this study

Official title: Long-term Safety of Subjects Continuing Dolutegravir After Participation in Clinical Studies of Dolutegravir in Russian Federation

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.

Being tested
Dolutegravir 50 mg
Keywords
Phase 4, Russian Federation, dolutegravir, long-term safety, Human Immunodeficiency Virus
Medical subject headings
Infections, Acquired Immunodeficiency Syndrome, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dolutegravir 50 mgDrug

    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.

Study groups in NCT03314064
Study groupRoleWhat they receive
HIV positive subjects continuing DTGExperimentalHIV 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.
Receives: Drug: Dolutegravir 50 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 7 months approximately

  2. Number of subjects with abnormal hematology parameters

    Hematology parameters will be evaluated and will be graded according to DAIDS toxicity scale.

    Measured: Up to 7 months approximately

  3. Number of subjects with abnormal clinical chemistry parameters

    Clinical chemistry parameters will be evaluated and will be graded according to DAIDS toxicity scale.

    Measured: Up to 7 months approximately

  4. Number of subjects with abnormal urine parameters

    Urine parameters will be evaluated and will be graded according to DAIDS toxicity scale.

    Measured: Up to 7 months approximately

  5. Number of subjects with abnormal electrocardiogram (ECG)

    The number of subjects with abnormal ECG results will be summarized.

    Measured: Up to 7 months approximately

  6. Number of subjects with abnormal radiological scan

    The number of subjects with abnormal radiological scan will be summarized.

    Measured: Up to 7 months approximately

  7. Number of subjects with abnormal physical examination

    The number of subjects with abnormal physical examination will be summarized

    Measured: Up to 7 months approximately

  8. Number of subjects with abnormal blood pressure

    The number of subjects with abnormal blood pressure will be summarized.

    Measured: Up to 7 months approximately

  9. Number of subjects with abnormal heart rate

    The number of subjects with abnormal heart rate will be summarized.

    Measured: Up to 7 months approximately

  10. Number of subjects with abnormal temperature

    The number of subjects with abnormal body temperature will be summarized.

    Measured: Up to 7 months approximately

  11. Number of subjects with abnormal respiratory rate

    The number of subjects with abnormal respiratory rate will be summarized.

    Measured: Up to 7 months approximately

  12. Number of subjects receiving concomitant medications

    All the concomitant medications that the subject will receive will be evaluated.

    Measured: Up to 7 months approximately

  13. 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.

    Measured: Up to 7 months approximately

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2017
  2. Study start8 Dec 2016
  3. Primary completion1 Oct 2018
  4. Study completion1 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03314064
Sponsor's protocol ID
205908
Status last verified
Jan 2019
First submitted
13 Oct 2017
Last updated
4 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dolutegravir 50 mg in people with Infection, Human Immunodeficiency Virus and HIV Infections, run by ViiV Healthcare at 11 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with drug related Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 7 months approximately). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03314064.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.

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