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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV positive subjects continuing DTG | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dolutegravir 50 mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 7 months approximately |
| Number of subjects with abnormal hematology parameters | Hematology parameters will be evaluated and will be graded according to DAIDS toxicity scale. | Up to 7 months approximately |
| Number of subjects with abnormal clinical chemistry parameters | Clinical chemistry parameters will be evaluated and will be graded according to DAIDS toxicity scale. | Up to 7 months approximately |
| Number of subjects with abnormal urine parameters | Urine parameters will be evaluated and will be graded according to DAIDS toxicity scale. | Up to 7 months approximately |
| Number of subjects with abnormal electrocardiogram (ECG) | The number of subjects with abnormal ECG results will be summarized. | Up to 7 months approximately |
| Number of subjects with abnormal radiological scan | The number of subjects with abnormal radiological scan will be summarized. | Up to 7 months approximately |
| Number of subjects with abnormal physical examination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| GSK Clinical Trials | GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Kazan' | 420061 | Russia | |||
| GSK Investigational Site |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
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| ID | Term |
|---|---|
| C562325 | dolutegravir |
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This is an open label, single group study where the eligible subjects will receive DTG 50 mg once daily.
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The number of subjects with abnormal physical examination will be summarized
| Up to 7 months approximately |
| Number of subjects with abnormal blood pressure | The number of subjects with abnormal blood pressure will be summarized. | Up to 7 months approximately |
| Number of subjects with abnormal heart rate | The number of subjects with abnormal heart rate will be summarized. | Up to 7 months approximately |
| Number of subjects with abnormal temperature | The number of subjects with abnormal body temperature will be summarized. | Up to 7 months approximately |
| Number of subjects with abnormal respiratory rate | The number of subjects with abnormal respiratory rate will be summarized. | Up to 7 months approximately |
| Number of subjects receiving concomitant medications | All the concomitant medications that the subject will receive will be evaluated. | Up to 7 months approximately |
| 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. | Up to 7 months approximately |
| Kemerovo |
| 650056 |
| Russia |
| GSK Investigational Site | Krasnodar | 350015 | Russia |
| GSK Investigational Site | Moscow | 105275 | Russia |
| GSK Investigational Site | N.Novgorod | 603005 | Russia |
| GSK Investigational Site | Oryol | 302040 | Russia |
| GSK Investigational Site | Saint Petersburg | 190103 | Russia |
| GSK Investigational Site | Saint Petersburg | 196645 | Russia |
| GSK Investigational Site | Smolensk | 214006 | Russia |
| GSK Investigational Site | Toliyatti | 445846 | Russia |
| GSK Investigational Site | Yekaterinburg | 620149 | Russia |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |