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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-018001-51 | EudraCT Number |
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| Name | Class |
|---|---|
| Shionogi | INDUSTRY |
| GlaxoSmithKline | INDUSTRY |
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ING111762 is a 48 week, randomized, double-blind, active-controlled, multicenter, parallel group, non-inferiority study. The study will be conducted in at least 688 HIV-1 infected antiretroviral experienced, integrase-naïve subjects. Subjects will be randomized 1:1 to receive GSK1349572 50 mg once daily or raltegravir (RAL) 400 mg twice daily, each added to an investigator selected background regimen consisting of at least one fully active agent plus no more than one second single agent which may or may not be active. Antiviral activity, safety, pharmacokinetics (PK), and development of viral resistance will be evaluated.
ING111762 is a 48 week, randomized, double-blind, active-controlled, multicenter, parallel group, non-inferiority study. The study will be conducted in at least 688 HIV-1 infected antiretroviral experienced, integrase-naïve subjects. Subjects will be randomized 1:1 to receive GSK1349572 50 mg once daily or raltegravir (RAL) 400 mg twice daily, each added to an investigator selected background regimen consisting of at least one fully active agent plus no more than one second single agent which may or may not be active. Antiviral activity, safety, pharmacokinetics (PK), and development of viral resistance will be evaluated.
Subjects must have documented genotypic or phenotypic resistance to at least one member of each of at least two antiretroviral therapy (ART) drug classes [nucleoside/nucleotide reverse transcriptase inhibitor (N[t]RTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI), fusion inhibitor (T20), or entry inhibitor (chemokine receptor 5 [CCR5] antagonist)].
The primary analysis will take place after the last subject completes 48 weeks on therapy. An additional data cut and analysis will be conducted after the last subject completes 24 weeks on therapy.
Subjects randomized to GSK1349572 who successfully complete Week 48 will continue to received GSK1349572 until either it is locally available, until they no longer derive clinical benefit, until they meet a protocol-defined reason for discontinuation, or until development of the compound is terminated.
ViiV Healthcare is the sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1349572 + Raltegravir Placebo | Experimental | Subjects will receive GSK1349572 50mg once daily plus raltegravir placebo twice daily. |
|
| Raltegravir + GSK1349572 Placebo | Active Comparator | Subjects will receive raltegravir 400mg twice daily plus GSK1349572 placebo once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1349572 | Drug | 50mg once daily |
| |
| Raltegravir |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 48 | The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 c/mL at Week 48 was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm. This algorithm treated all participants without HIV-1 RNA at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the randomized phase of the study. | At Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants (Par.) With Detectable Virus That Has Genotypic or Phenotypic Evidence of Treatment-emergent Integrase Inhibitor (INI) Resistance at Time of Protocol Defined Virology Failure (PDVF) | For par. meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure and Baseline were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) virologic non-response: a decrease in plasma HIV-1 RNA of <1 logarithm to base 10 (log10) copies/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/ mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) virologic rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.Treatment-emergent IN mutations are those detected at the time of PDVF but not at Baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Values of Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48 | The absolute value data for CD8+ cell count was planned to be evaluated. The results for this outcome measure will never be posted. | At Weeks 4, 8, 12, 16, 24, 32, 40, and 48 |
| Change From Baseline in CD8+ Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48 |
Inclusion Criteria:
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 | Birmingham | Alabama | 35294 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23830355 | Background | Cahn P, Pozniak AL, Mingrone H, Shuldyakov A, Brites C, Andrade-Villanueva JF, Richmond G, Buendia CB, Fourie J, Ramgopal M, Hagins D, Felizarta F, Madruga J, Reuter T, Newman T, Small CB, Lombaard J, Grinsztejn B, Dorey D, Underwood M, Griffith S, Min S; extended SAILING Study Team. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet. 2013 Aug 24;382(9893):700-8. doi: 10.1016/S0140-6736(13)61221-0. Epub 2013 Jul 3. | |
| 40990223 |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted when justified, for up to another 12 months.
1441 participants screened; 724 participants randomized, of which 5 participants did not receive study treatment. 719 participants received at least 1 dose of study medication creating the intent to treat exposed (ITT-E) Population.
This study was conducted to demonstrate non-inferior antiviral activity of dolutegravir (DTG) 50 milligram (mg) once daily versus raltegravir (RAL) 400 mg twice daily in participants with human immunodeficiency viruses (HIV)-1. Long-term antiviral activity, tolerability & safety were also evaluated
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| ID | Title | Description |
|---|---|---|
| FG000 | DTG 50 mg OD | Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continued to have access to DTG in the Open-Label phase of the study. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Double-blind Phase (Up to Week [Wk] 48) |
|
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| Drug |
400mg twice daily |
|
| GSK1349572 Placebo | Drug | Inactive placebo tablet once daily |
|
| Raltegravir Placebo | Drug | Inactive placebo tablet twice daily |
|
| Baseline (Day 1) until PDVF (Up to Week 48) |
| Number of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24 | The number of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 c/mL at Week 24 was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm. This algorithm treated all participants without HIV-1 RNA at Week 24 as nonresponders, as well as participants who switched their concomitant ART prior to Week 24 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA measurement through Week 24 (within window) while the participant was on-treatment. The result below corresponds to the Week 24 interim analysis. | At Week 24 |
| Number of Participants With Plasma HIV-1 RNA <400 c/mL at Week 24 and Week 48 | The number of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <400 c/mL at the visit of interest was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm. This algorithm treated all participants without HIV-1 RNA at the visit of interest as nonresponders, as well as participants who switched their concomitant ART prior to the visit of interest as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA measurment (within window) for the timepoint of interest while the participant was on-treatment. | At Week 24 and Week 48 |
| Absolute Values of Cluster of Differentiation 4+ (CD4+) Cell Counts at Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144 | Blood samples were collected at specified time points to assess CD4+ using flow cytometry. Median and interquartile range are presented. Baseline was the latest pre-dose assessment value (Day 1). | Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144 |
| Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12,16, 24, 32, 40, 48, 96 and 144 | Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline was the latest pre-dose assessment value (Day 1). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Median and interquartile range is presented. | Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144 |
| Number of Participants With Post-Baseline HIV-associated Conditions, Excluding Recurrences, and Disease Progressions | Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of following conditions (CON), without any CON listed in Categories B and C: Asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: Symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C:Clinical CON listed in acquired immunodeficiency syndrome (AIDS) surveillance case definition. Indicators of CDP defined as:CDC CAT A at Baseline (BS) to CDC CAT C event (EV); CDC CAT B at BS to CDC CAT C EV; CDC CAT C at BS to new CDC CAT C EV; or CDC CAT A, B, or C at BS to death. | Up to Week 480 |
| Number of Participants With Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities | All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death. Higher the grade, more severe the symptoms. | From Baseline (Day 1) until Week 48, including participants with post-treatment events occurring after Week 48 for participants not entering the post-Week 48 Open-Label phase of the study |
| Number of Participants With Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities | Blood samples were collected for the analysis of clinical chemistry and hematology parameters: Alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hypoonatremia, LDL cholesterol, lipase, total bilirubin, triglycerides, hemoglibin, neutrophils, platelets, white blood cells. Any abnormality in clinical chemistry and hematology parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).Higher the grade, more severe the symptoms. | From Week 48 to Week 480 |
| DTG PK Parameters Including Maximum Plasma Drug Concentration (Cmax), Minimal Plasma Drug Concentration (Cmin), and Average Plasma Pre-dose Concentration (C0_avg) | Cmax, Cmin and C0_avg were assessed by population pharmacokinetic (PK) modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48. Cmax, Cmin and C0_avg were estimated and reported here. | Pre-dose and at 1 to 3 hours or 4 to 12 hours post-dose at Week 4; Pre-dose at Week 24; Pre-dose and 1 to 3 hours or 4 to 12 hours post-dose at Week 48 |
| DTG PK Parameter Including Pre-dose Concentration (C0) | C0 was assessed by population PK modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48. DTG predose concentration (C0) at Week 4, Week 24, and Week 48 was estimated and reported here. | Pre-dose at Weeks 4, 24 and 48 |
| DTG PK Parameters Including Area Under the Plasma Concentration-time Curve From Time Zero to Time Tau Over a Dosing Interval at Steady State (AUC[0-tau]) | AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure over time. AUC(0-tau) is defined as the area under the plasma concentration-time curve from time zero to time tau over a dosing interval at steady state, where tau is the length of the dosing interval of DTG. AUC was assessed by population pharmacokinetic (PK) modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48. | Pre-dose and at 1 to 3 hours or 4 to 12 hours post-dose at Week 4; Pre-dose at Week 24; Pre-dose and 1 to 3 hours or 4 to 12 hours post-dose at Week 48 |
| Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Utility Score | The EQ-5D-3L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 3 levels for each dimension including 1=no problems, 2=some problems, 3=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-3L utility score ranges from -0.594 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. | Baseline (Day 1) and at Weeks 24 and 48 |
| Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Thermometer Scores | The EQ-5D-3L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 3 levels for each dimension including 1=no problems, 2=some problems, 3=extreme problems. EQ-5D-3L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Participants were asked to rate their current health status using the visual analogue scale 'Thermometer'. Score ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate better heath. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. | Baseline (Day 1) and at Weeks 24 and 48 |
Change from Baseline data for CD8+ cell count was planned to be evaluated. The results for this outcome measure will never be posted. |
| Baseline (Day 1); Weeks 4, 8, 12, 16, 24, 32, 40, and 48 |
| Phoenix |
| Arizona |
| 85012 |
| United States |
| GSK Investigational Site | Little Rock | Arkansas | 72207 | United States |
| GSK Investigational Site | Bakersfield | California | 93301 | United States |
| GSK Investigational Site | Beverly Hills | California | 90211 | United States |
| GSK Investigational Site | Long Beach | California | 90813 | United States |
| GSK Investigational Site | Los Angeles | California | 90036 | United States |
| GSK Investigational Site | Los Angeles | California | 90048 | United States |
| GSK Investigational Site | Los Angeles | California | 90069 | United States |
| GSK Investigational Site | Oakland | California | 94609 | United States |
| GSK Investigational Site | New Haven | Connecticut | 06520 | United States |
| GSK Investigational Site | Norwalk | Connecticut | 06850 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20007 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20009 | United States |
| GSK Investigational Site | Daytona Beach | Florida | 32117 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33308 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33316 | United States |
| GSK Investigational Site | Ft. Pierce | Florida | 34982 | United States |
| GSK Investigational Site | Orlando | Florida | 32803 | United States |
| GSK Investigational Site | Orlando | Florida | 32806 | United States |
| GSK Investigational Site | West Palm Beach | Florida | 33401 | United States |
| GSK Investigational Site | Wilton Manors | Florida | 33305 | United States |
| GSK Investigational Site | Augusta | Georgia | 30912 | United States |
| GSK Investigational Site | Savannah | Georgia | 31401 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612 | United States |
| GSK Investigational Site | Maywood | Illinois | 60153 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46202 | United States |
| GSK Investigational Site | Iowa City | Iowa | 52242 | United States |
| GSK Investigational Site | Springfield | Massachusetts | 01105 | United States |
| GSK Investigational Site | Detroit | Michigan | 48202 | United States |
| GSK Investigational Site | Lansing | Michigan | 48911 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55404 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55415 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64106 | United States |
| GSK Investigational Site | St Louis | Missouri | 63108 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68106 | United States |
| GSK Investigational Site | Hillsborough | New Jersey | 08844 | United States |
| GSK Investigational Site | Neptune City | New Jersey | 07753 | United States |
| GSK Investigational Site | Newark | New Jersey | 07102 | United States |
| GSK Investigational Site | Newark | New Jersey | 07103 | United States |
| GSK Investigational Site | New York | New York | 10003 | United States |
| GSK Investigational Site | New York | New York | 10011 | United States |
| GSK Investigational Site | The Bronx | New York | 10467 | United States |
| GSK Investigational Site | Valhalla | New York | 10595 | United States |
| GSK Investigational Site | Chapel Hill | North Carolina | 27514 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28207 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28209 | United States |
| GSK Investigational Site | Durham | North Carolina | 27710 | United States |
| GSK Investigational Site | Greenville | North Carolina | 27834 | United States |
| GSK Investigational Site | Akron | Ohio | 44304 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45267 | United States |
| GSK Investigational Site | Portland | Oregon | 97210 | United States |
| GSK Investigational Site | Allentown | Pennsylvania | 18102 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19140 | United States |
| GSK Investigational Site | Providence | Rhode Island | 02906 | United States |
| GSK Investigational Site | Dallas | Texas | 75204 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| GSK Investigational Site | Fort Worth | Texas | 76104 | United States |
| GSK Investigational Site | Houston | Texas | 77004 | United States |
| GSK Investigational Site | Houston | Texas | 77098 | United States |
| GSK Investigational Site | Houston | Texas | 77401 | United States |
| GSK Investigational Site | Longview | Texas | 75605 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84132 | United States |
| GSK Investigational Site | Annandale | Virginia | 22003 | United States |
| GSK Investigational Site | Seattle | Washington | 98104 | United States |
| GSK Investigational Site | Spokane | Washington | 99204 | United States |
| GSK Investigational Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1264AAJ | Argentina |
| GSK Investigational Site | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1405CKC | Argentina |
| GSK Investigational Site | Ciudad de Buenos Aires | Buenos Aires | C1202ABB | Argentina |
| GSK Investigational Site | Rosario | Santa Fe Province | 2000 | Argentina |
| GSK Investigational Site | Buenos Aires | 1141 | Argentina |
| GSK Investigational Site | Buenos Aires | C1181ACH | Argentina |
| GSK Investigational Site | Darlinghurst | New South Wales | 2010 | Australia |
| GSK Investigational Site | Melbourne | Victoria | 3004 | Australia |
| GSK Investigational Site | Antwerp | 2000 | Belgium |
| GSK Investigational Site | Brussels | 1000 | Belgium |
| GSK Investigational Site | Charleroi | 6000 | Belgium |
| GSK Investigational Site | Liège | 4000 | Belgium |
| GSK Investigational Site | Belo Horizonte | Minas Gerais | 30130100 | Brazil |
| GSK Investigational Site | Curitiba | Paraná | 80240-280 | Brazil |
| GSK Investigational Site | São Paulo | São Paulo | 01246-090 | Brazil |
| GSK Investigational Site | São Paulo | São Paulo | 04040-002 | Brazil |
| GSK Investigational Site | Rio de Janeiro | 21040-360 | Brazil |
| GSK Investigational Site | Salvador | 40110-060 | Brazil |
| GSK Investigational Site | Santos | 11045-904 | Brazil |
| GSK Investigational Site | São Paulo | 04121-000 | Brazil |
| GSK Investigational Site | Vitória | 29041-091 | Brazil |
| GSK Investigational Site | Vancouver | British Columbia | V6Z 2C7 | Canada |
| GSK Investigational Site | Hamilton | Ontario | L8N3Z5 | Canada |
| GSK Investigational Site | Toronto | Ontario | M4T 3A7 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5G 2N2 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2L 5B1 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2W 1T8 | Canada |
| GSK Investigational Site | Puente Alto - Santiago | Región Metro de Santiago | 8207257 | Chile |
| GSK Investigational Site | Santiago | Región Metro de Santiago | 8320000 | Chile |
| GSK Investigational Site | Santiago | Región Metro de Santiago | 8330074 | Chile |
| GSK Investigational Site | Santiago | Región Metro de Santiago | 8900088 | Chile |
| GSK Investigational Site | Santiago | 8360159 | Chile |
| GSK Investigational Site | Bordeaux | 33000 | France |
| GSK Investigational Site | Garches | 92380 | France |
| GSK Investigational Site | Le Kremlin-Bicêtre | 94275 | France |
| GSK Investigational Site | Marseille | 13009 | France |
| GSK Investigational Site | Nice | 06202 | France |
| GSK Investigational Site | Orléans | 45100 | France |
| GSK Investigational Site | Paris | 75018 | France |
| GSK Investigational Site | Paris | 75475 | France |
| GSK Investigational Site | Paris | 75651 | France |
| GSK Investigational Site | Paris | 75970 | France |
| GSK Investigational Site | Tourcoing | 59208 | France |
| GSK Investigational Site | Athens | 11527 | Greece |
| GSK Investigational Site | Athens | 161 21 | Greece |
| GSK Investigational Site | Piraeus | 18536 | Greece |
| GSK Investigational Site | Rio, Patras | 26504 | Greece |
| GSK Investigational Site | Budapest | 1097 | Hungary |
| GSK Investigational Site | Modena | Emilia-Romagna | 41100 | Italy |
| GSK Investigational Site | Busto Arsizio (VA) | Lombardy | 21052 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20127 | Italy |
| GSK Investigational Site | Monza | Lombardy | 20900 | Italy |
| GSK Investigational Site | Turin | Piedmont | 10149 | Italy |
| GSK Investigational Site | Cagliari | Sardinia | 09121 | Italy |
| GSK Investigational Site | León, Guanajuato | Guanajuato | 37320 | Mexico |
| GSK Investigational Site | Guadalajara | Jalisco | 44280 | Mexico |
| GSK Investigational Site | Cuautitlán, Estado de México | State of Mexico | 54800 | Mexico |
| GSK Investigational Site | Mexico City | 03720 | Mexico |
| GSK Investigational Site | Amsterdam | 1105 AZ | Netherlands |
| GSK Investigational Site | Rotterdam | 3079 DZ | Netherlands |
| GSK Investigational Site | Chorzów | 41-500 | Poland |
| GSK Investigational Site | Bucharest | 021105 | Romania |
| GSK Investigational Site | Bucharest | 030303 | Romania |
| GSK Investigational Site | Constanța | 900709 | Romania |
| GSK Investigational Site | Kazan' | 420097 | Russia |
| GSK Investigational Site | Krasnodar | 350015 | Russia |
| GSK Investigational Site | Moscow | 105275 | Russia |
| GSK Investigational Site | Moscow | 129110 | Russia |
| GSK Investigational Site | N.Novgorod | 603005 | Russia |
| GSK Investigational Site | Perm | 614088 | Russia |
| GSK Investigational Site | Ryazan | 390046 | Russia |
| GSK Investigational Site | Saint Petersburg | 190103 | Russia |
| GSK Investigational Site | Saratov | 410009 | Russia |
| GSK Investigational Site | Toliyatti | 445846 | Russia |
| GSK Investigational Site | Volgograd | 400040 | Russia |
| GSK Investigational Site | Yekaterinburg | 620149 | Russia |
| GSK Investigational Site | Bloemfontein | 9301 | South Africa |
| GSK Investigational Site | Dundee | 3000 | South Africa |
| GSK Investigational Site | Durban | 4001 | South Africa |
| GSK Investigational Site | (Móstoles) Madrid | 28935 | Spain |
| GSK Investigational Site | A Coruña | 15006 | Spain |
| GSK Investigational Site | Alicante | 03010 | Spain |
| GSK Investigational Site | Badalona | 08916 | Spain |
| GSK Investigational Site | Barcelona | 08025 | Spain |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Cartagena (Murcia) | 30202 | Spain |
| GSK Investigational Site | Elche (Alicante) | 03202 | Spain |
| GSK Investigational Site | Granada | 18003 | Spain |
| GSK Investigational Site | Granada | 18014 | Spain |
| GSK Investigational Site | Granollers (Barcelona) | 08400 | Spain |
| GSK Investigational Site | Madrid | 28006 | Spain |
| GSK Investigational Site | Madrid | 28029 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Mataró | 08304 | Spain |
| GSK Investigational Site | Murcia | 30003 | Spain |
| GSK Investigational Site | Sabadell (Barcelona) | 08208 | Spain |
| GSK Investigational Site | San Sebastián | 20014 | Spain |
| GSK Investigational Site | Seville | 41007 | Spain |
| GSK Investigational Site | Seville | 41013 | Spain |
| GSK Investigational Site | Valencia | 46010 | Spain |
| GSK Investigational Site | Valencia | 46015 | Spain |
| GSK Investigational Site | Kaohsiung City | 813 | Taiwan |
| GSK Investigational Site | Kaohsiung City | 824 | Taiwan |
| GSK Investigational Site | Taichung | 404 | Taiwan |
| GSK Investigational Site | Taichung | 406 | Taiwan |
| GSK Investigational Site | Taipei | 11217 | Taiwan |
| GSK Investigational Site | Woolwich, London | London | SE18 4QH | United Kingdom |
| GSK Investigational Site | Crumpsall, Manchester | M8 5RB | United Kingdom |
| GSK Investigational Site | Liverpool | L7 8XP | United Kingdom |
| GSK Investigational Site | Tooting, London | SW17 0QT | United Kingdom |
| Derived |
| Benlarbi M, Richard J, Clemente T, Bourassa C, Tolbert WD, Prakash M, Chandravanshi M, Clark A, Pazgier M, Durand M, Castagna A, Finzi A. Fostemsavir Decreases the Levels of Anti-gp120 CD4-Induced Antibodies in Heavily Treatment-Experienced People With HIV. J Infect Dis. 2026 Feb 18;233(2):247-256. doi: 10.1093/infdis/jiaf461. |
| FG001 | RAL 400 mg BID | Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GlaxoSmithKline (GSK) continued to supply RAL in the Open-Label Phase until commercially available. |
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| ITT-E Population |
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| Modified (m)ITT-E Population |
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| COMPLETED |
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| NOT COMPLETED |
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| Open-label Phase:From Wk 48 up to Wk 480 |
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Four participants from one closed site were removed from the ITT-E Population creating the modified ITT-E Population with 715 participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DTG 50 mg OD | Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continued to have access to DTG in the Open-Label phase of the study. |
| BG001 | RAL 400 mg BID | Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GlaxoSmithKline (GSK) continued to supply RAL in the Open-Label Phase until commercially available. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Baseline Characteristic data are reported for members of the modified Intent-To-Treat Exposed Population, all randomized participants who received at least one dose of IP excluding four participants at one site, which was closed due to Good Clinical Practice (GCP) non-compliance issues in another ViiV sponsored trial. | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Baseline Characteristic data are reported for members of the modified Intent-To-Treat Exposed Population, all randomized participants who received at least one dose of IP excluding four participants at one site, which was closed due to Good Clinical Practice (GCP) non-compliance issues in another ViiV sponsored trial. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Baseline Characteristic data are reported for members of the modified Intent-To-Treat Exposed Population, all randomized participants who received at least one dose of IP excluding four participants at one site, which was closed due to Good Clinical Practice (GCP) non-compliance issues in another ViiV sponsored trial. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 48 | The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 c/mL at Week 48 was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm. This algorithm treated all participants without HIV-1 RNA at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the randomized phase of the study. | Modified Intent-To-Treat Exposed (mITT-E) Population: All randomized participants who received at least one dose of investigational product (IP) excluding four participants at one site, which was closed due to Good Clinical Practice (GCP) non-compliance issues in another ViiV sponsored trial. | Posted | Number | Percentage of participants | At Week 48 |
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| Secondary | Number of Participants (Par.) With Detectable Virus That Has Genotypic or Phenotypic Evidence of Treatment-emergent Integrase Inhibitor (INI) Resistance at Time of Protocol Defined Virology Failure (PDVF) | For par. meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure and Baseline were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) virologic non-response: a decrease in plasma HIV-1 RNA of <1 logarithm to base 10 (log10) copies/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/ mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) virologic rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.Treatment-emergent IN mutations are those detected at the time of PDVF but not at Baseline. | mITT-E Population | Posted | Count of Participants | Participants | Baseline (Day 1) until PDVF (Up to Week 48) |
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| Secondary | Number of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24 | The number of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 c/mL at Week 24 was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm. This algorithm treated all participants without HIV-1 RNA at Week 24 as nonresponders, as well as participants who switched their concomitant ART prior to Week 24 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA measurement through Week 24 (within window) while the participant was on-treatment. The result below corresponds to the Week 24 interim analysis. | mITT-E Population | Posted | Count of Participants | Participants | At Week 24 |
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| Secondary | Number of Participants With Plasma HIV-1 RNA <400 c/mL at Week 24 and Week 48 | The number of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <400 c/mL at the visit of interest was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm. This algorithm treated all participants without HIV-1 RNA at the visit of interest as nonresponders, as well as participants who switched their concomitant ART prior to the visit of interest as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA measurment (within window) for the timepoint of interest while the participant was on-treatment. | mITT-E Population | Posted | Count of Participants | Participants | At Week 24 and Week 48 |
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| Secondary | Absolute Values of Cluster of Differentiation 4+ (CD4+) Cell Counts at Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144 | Blood samples were collected at specified time points to assess CD4+ using flow cytometry. Median and interquartile range are presented. Baseline was the latest pre-dose assessment value (Day 1). | mITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by "n=X" in the category titles). | Posted | Median | Inter-Quartile Range | Cells per cubic millimeter | Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144 |
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| Secondary | Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12,16, 24, 32, 40, 48, 96 and 144 | Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline was the latest pre-dose assessment value (Day 1). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Median and interquartile range is presented. | mITT-E Population Only those participants with data available at the specified data points were assessed (represented by "n=X" in the category titles). | Posted | Median | Inter-Quartile Range | Cells per cubic millimeter | Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144 |
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| Secondary | Number of Participants With Post-Baseline HIV-associated Conditions, Excluding Recurrences, and Disease Progressions | Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of following conditions (CON), without any CON listed in Categories B and C: Asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: Symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C:Clinical CON listed in acquired immunodeficiency syndrome (AIDS) surveillance case definition. Indicators of CDP defined as:CDC CAT A at Baseline (BS) to CDC CAT C event (EV); CDC CAT B at BS to CDC CAT C EV; CDC CAT C at BS to new CDC CAT C EV; or CDC CAT A, B, or C at BS to death. | mITT-E Population | Posted | Count of Participants | Participants | Up to Week 480 |
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| Secondary | Number of Participants With Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities | All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death. Higher the grade, more severe the symptoms. | Safety Population comprised of all participants who received at least one dose of IP (i.e., DTG or RAL) | Posted | Count of Participants | Participants | From Baseline (Day 1) until Week 48, including participants with post-treatment events occurring after Week 48 for participants not entering the post-Week 48 Open-Label phase of the study |
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| Secondary | Number of Participants With Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities | Blood samples were collected for the analysis of clinical chemistry and hematology parameters: Alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hypoonatremia, LDL cholesterol, lipase, total bilirubin, triglycerides, hemoglibin, neutrophils, platelets, white blood cells. Any abnormality in clinical chemistry and hematology parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).Higher the grade, more severe the symptoms. | Safety Population. Only those participants who completed Week 48 and continued into open-label phase were included in this analysis. | Posted | Count of Participants | Participants | From Week 48 to Week 480 |
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| Secondary | DTG PK Parameters Including Maximum Plasma Drug Concentration (Cmax), Minimal Plasma Drug Concentration (Cmin), and Average Plasma Pre-dose Concentration (C0_avg) | Cmax, Cmin and C0_avg were assessed by population pharmacokinetic (PK) modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48. Cmax, Cmin and C0_avg were estimated and reported here. | PK Concentration Population comprised of all participants who received DTG, underwent sparse PK sampling during the study, and provided evaluable DTG plasma concentration data. Only those participants with data available at the specified data points were assessed (represented by "n=X" in the category titles). | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/milliliter (µg/mL) | Pre-dose and at 1 to 3 hours or 4 to 12 hours post-dose at Week 4; Pre-dose at Week 24; Pre-dose and 1 to 3 hours or 4 to 12 hours post-dose at Week 48 |
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| Secondary | DTG PK Parameter Including Pre-dose Concentration (C0) | C0 was assessed by population PK modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48. DTG predose concentration (C0) at Week 4, Week 24, and Week 48 was estimated and reported here. | PK Concentration Population comprised of all participants who received DTG, underwent sparse PK sampling during the study, and provided evaluable DTG plasma concentration data. Only those participants with data available at the specified data points were assessed (represented by "n=X" in the category titles). | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/milliliter (µg/mL) | Pre-dose at Weeks 4, 24 and 48 |
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| Secondary | DTG PK Parameters Including Area Under the Plasma Concentration-time Curve From Time Zero to Time Tau Over a Dosing Interval at Steady State (AUC[0-tau]) | AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure over time. AUC(0-tau) is defined as the area under the plasma concentration-time curve from time zero to time tau over a dosing interval at steady state, where tau is the length of the dosing interval of DTG. AUC was assessed by population pharmacokinetic (PK) modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48. | PK Concentration Population: all participants who received DTG, underwent sparse PK sampling during the study, and provided evaluable DTG plasma concentration data. Only those participants available at the indicated time points were assessed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms*hour/milliliter (µg*hr/mL) | Pre-dose and at 1 to 3 hours or 4 to 12 hours post-dose at Week 4; Pre-dose at Week 24; Pre-dose and 1 to 3 hours or 4 to 12 hours post-dose at Week 48 |
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| Secondary | Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Utility Score | The EQ-5D-3L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 3 levels for each dimension including 1=no problems, 2=some problems, 3=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-3L utility score ranges from -0.594 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. | mITT-E Population. Only those participants with data available at the specified data points were assessed (represented by "n=X" in the category titles). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1) and at Weeks 24 and 48 |
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| Secondary | Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Thermometer Scores | The EQ-5D-3L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 3 levels for each dimension including 1=no problems, 2=some problems, 3=extreme problems. EQ-5D-3L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Participants were asked to rate their current health status using the visual analogue scale 'Thermometer'. Score ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate better heath. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. | mITT-E Population. Only those participants with data available at the specified data points were assessed (represented by "n=X" in the category titles). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1) and at Weeks 24 and 48 |
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| Other Pre-specified | Absolute Values of Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48 | The absolute value data for CD8+ cell count was planned to be evaluated. The results for this outcome measure will never be posted. | mITT-E Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted. | Posted | At Weeks 4, 8, 12, 16, 24, 32, 40, and 48 |
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| Other Pre-specified | Change From Baseline in CD8+ Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48 | Change from Baseline data for CD8+ cell count was planned to be evaluated. The results for this outcome measure will never be posted. | mITT-E Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted. | Posted | Baseline (Day 1); Weeks 4, 8, 12, 16, 24, 32, 40, and 48 |
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Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected from the start of study medication to the end of the study (up to Week 480)
SAEs, non-serious AEs and all-cause mortality were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DTG~50mg QD | Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continued to have access to DTG in the Open-Label phase of the study. | 6 | 357 | 73 | 357 | 250 | 357 |
| EG001 | RAL~400mg BID | Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK continued to supply RAL in the Open-Label Phase until it was commercially available. | 4 | 362 | 46 | 362 | 206 | 362 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Hepatotoxicity | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Acute hepatic failure | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
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| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
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| Alcohol abuse | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Alveolar proteinosis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Anal ulcer | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Aortic arteriosclerosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
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| Arteriosclerosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Cardiomyopathy | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Cerebrovascular disorder | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
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| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
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| Coagulation factor deficiency | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Cytomegalovirus oesophagitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Depression suicidal | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| Disseminated tuberculosis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Extrapulmonary tuberculosis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Gangrene | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Gas gangrene | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Genital herpes simplex | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Histoplasmosis disseminated | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
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| Immune reconstitution inflammatory syndrome | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
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| Immunoblastic lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Infective myositis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Intervertebral discitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Iridocyclitis | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Joint abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Pneumonia legionella | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Liver disorder | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Malignant hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
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| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
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| Methaemoglobinaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
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| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Oral mucosal blistering | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Orchitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pancreatitis relapsing | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Parvovirus infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Substance abuse | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cerebral toxoplasmosis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Tuberculosis liver | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vulval neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Hepatitis A | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Renal abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Anal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Gastrointestinal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Open fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Uterine perforation | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Lacunar stroke | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nasal valve collapse | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Iritis | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 23.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | ViiV Healthcare | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C562325 | dolutegravir |
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Met protocol-defined stopping criteria |
|
| Adverse Event |
|
| Lost to Follow-up |
|
| Male |
|
| American Indian or Alaska Native |
|
| Asian-Central/South Asian Heritage |
|
| Asian-East Asian Heritage |
|
| Asian-South East Asian Heritage |
|
| Native Hawaiian or Other Pacific Islander |
|
| White-Arabic/North African Heritage |
|
| White-White/Caucasian/European Heritage |
|
| Mixed Race |
|
| Unknown |
|
Non-inferiority of DTG 50 mg and RAL at Week 48 can be concluded if the lower bound of a two-sided 95% confidence interval (CI) for the difference in percentages (DTG - RAL) is greater than -12%. If non-inferiority were established, superiority would be tested at the nominal 5% level based on a pre-specified testing procedure. |
| RAL 400 mg BID |
Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GlaxoSmithKline (GSK) continued to supply RAL in the Open-Label Phase until commercially available. |
|
|
| RAL 400 mg BID |
Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GlaxoSmithKline (GSK) continued to supply RAL in the Open-Label Phase until commercially available. |
|
|
| RAL 400 mg BID |
Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GlaxoSmithKline (GSK) continued to supply RAL in the Open-Label Phase until commercially available. |
|
|
|
|
|
|
| OG001 |
| RAL 400 mg BID |
Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GlaxoSmithKline (GSK) continued to supply RAL in the Open-Label Phase until commercially available. |
|
|
| OG001 | RAL 400 mg BID | Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GlaxoSmithKline (GSK) continued to supply RAL in the Open-Label Phase until commercially available. |
|
|
Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GlaxoSmithKline (GSK) continued to supply RAL in the Open-Label Phase until commercially available. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| OG001 |
| RAL 400 mg BID |
Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GlaxoSmithKline (GSK) continued to supply RAL in the Open-Label Phase until commercially available. |
|
|
| OG001 |
| RAL 400 mg BID |
Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GlaxoSmithKline (GSK) continued to supply RAL in the Open-Label Phase until commercially available. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
| Units | Counts |
|---|---|
| Participants |
|