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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001646-16 | EudraCT Number |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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ING114916 is an open-label, multi-center, expanded access (EAP) study
ING114916 is an open-label, multi-center EAP to allow access to patients with HIV-1 infection who have documented raltegravir or elvitegravir resistance, have limited treatment options and require dolutegravir to construct a viable anti-retroviral regimen for therapy. Patients must not be eligible for another ongoing dolutegravir clinical trial in order to participate in this EAP.
The duration of patient accrual into the study will extend until dolutegravir receives local (by country) regulatory approval.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dolutegravir | Drug | Eligible patients will receive DTG 50 mg given orally BID |
| Measure | Description | Time Frame |
|---|---|---|
| Expanded access | To to provide access in an open label protocol program to patients who have documented RAL or ELV resistance, who have limited treatment options and who require DTG to construct a viable ARV regimen for therapy | Not applicable for an expanded access study |
| Measure | Description | Time Frame |
|---|---|---|
| Assess adverse events | Assess any serious adverse events (SAEs) and adverse events (AEs) that lead to the discontinuation of DTG 50 mg BID | Not applicable for an expanded access study |
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Inclusion Criteria:
1. Adult subjects greater than 18 years of age 2. Documented HIV-1 RNA >/= 400 c/mL 3. Documented raltegravir or elvitegravir resistance 4. Inability to construct a viable background ART regimen with commercially available medications.
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 85012 | United States | ||
| GSK Investigational Site |
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| San Francisco |
| California |
| 94115 |
| United States |
| GSK Investigational Site | Denver | Colorado | 80218 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33311 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33316 | United States |
| GSK Investigational Site | Orlando | Florida | 32803 | United States |
| GSK Investigational Site | St. Petersburg | Florida | 33701 | United States |
| GSK Investigational Site | Vero Beach | Florida | 32960 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30322 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612 | United States |
| GSK Investigational Site | Chicago | Illinois | 60613 | United States |
| GSK Investigational Site | Chicago | Illinois | 60657 | United States |
| GSK Investigational Site | Topeka | Kansas | 66606 | United States |
| GSK Investigational Site | St Louis | Missouri | 63139 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68198 | United States |
| GSK Investigational Site | New York | New York | 10011 | United States |
| GSK Investigational Site | The Bronx | New York | 1057 | United States |
| GSK Investigational Site | Chapel Hill | North Carolina | 27599-7215 | United States |
| GSK Investigational Site | Lancaster | Pennsylvania | 17604 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| GSK Investigational Site | Austin | Texas | 78705 | United States |
| GSK Investigational Site | Dallas | Texas | 75204 | United States |
| GSK Investigational Site | Houston | Texas | 77004 | United States |
| GSK Investigational Site | Houston | Texas | 77098 | United States |
| GSK Investigational Site | Graz | A-8020 | Austria |
| GSK Investigational Site | Linz | A-4020 | Austria |
| GSK Investigational Site | Vienna | A-1140 | Austria |
| GSK Investigational Site | Antwerp | 2000 | Belgium |
| GSK Investigational Site | Brussels | 1000 | Belgium |
| GSK Investigational Site | Liège | 4000 | Belgium |
| GSK Investigational Site | Ipanema | Rio de Janeiro | 22410-906 | Brazil |
| GSK Investigational Site | Macaé | Rio de Janeiro | 27910-210 | Brazil |
| GSK Investigational Site | Porto Alegre | Rio Grande do Sul | 2006 | Brazil |
| GSK Investigational Site | São Paulo | São Paulo | 04121-000 | Brazil |
| GSK Investigational Site | Fortaleza | 60455-610 | Brazil |
| GSK Investigational Site | Maceió | 57035-110 | Brazil |
| GSK Investigational Site | Ribeirão Preto | 14048-900 | Brazil |
| GSK Investigational Site | Rio de Janeiro | 20520-054 | Brazil |
| GSK Investigational Site | Rio de Janeiro | 20725-090 | Brazil |
| GSK Investigational Site | Rio de Janeiro | 21040-900 | Brazil |
| GSK Investigational Site | São Paulo | 01246-000 | Brazil |
| GSK Investigational Site | Vittoria | 29020-020 | Brazil |
| GSK Investigational Site | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| GSK Investigational Site | Hamilton | Ontario | L8N3Z5 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5G 1K2 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2L 4P9 | Canada |
| GSK Investigational Site | Bordeaux | 33076 | France |
| GSK Investigational Site | Le Kremlin-Bicêtre | 94275 | France |
| GSK Investigational Site | Marseille | 13274 | France |
| GSK Investigational Site | Nice | 06202 | France |
| GSK Investigational Site | Paris | 75012 | France |
| GSK Investigational Site | Paris | 75013 | France |
| GSK Investigational Site | Paris | 75015 | France |
| GSK Investigational Site | Paris | 75475 | France |
| GSK Investigational Site | Paris | 75679 | France |
| GSK Investigational Site | Paris | 75877 | France |
| GSK Investigational Site | Paris | 75970 | France |
| GSK Investigational Site | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| GSK Investigational Site | Stuttgart | Baden-Wurttemberg | 70197 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60596 | Germany |
| GSK Investigational Site | Osnabrück | Lower Saxony | 49090 | Germany |
| GSK Investigational Site | Bonn | North Rhine-Westphalia | 53127 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 50674 | Germany |
| GSK Investigational Site | Lübeck | Schleswig-Holstein | 23538 | Germany |
| GSK Investigational Site | Mannheim | 68161 | Germany |
| GSK Investigational Site | Genoa | Liguria | 16128 | Italy |
| GSK Investigational Site | Genoa | Liguria | 16132 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20127 | Italy |
| GSK Investigational Site | Pavia | Lombardy | 27100 | Italy |
| GSK Investigational Site | Bagno A Ripoli (FI) | Tuscany | 50011 | Italy |
| GSK Investigational Site | Florence | Tuscany | 50134 | Italy |
| GSK Investigational Site | Modena | 41124 | Italy |
| GSK Investigational Site | Venezia | 30122 | Italy |
| GSK Investigational Site | Szczecin | 71-455 | Poland |
| 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 |
| 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 |
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| ID | Term |
|---|---|
| C562325 | dolutegravir |
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