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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01231516
Other study ID # 111762
Secondary ID 2009-018001-51
Status Completed
Phase Phase 3
First received
Last updated
Start date October 26, 2010
Est. completion date February 2, 2021

Study information

Verified date March 2022
Source ViiV Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 724
Est. completion date February 2, 2021
Est. primary completion date February 4, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Antiretroviral therapy (ART)-experienced, Human Immunodeficiency Virus (HIV) -1 infected adults at least 18 years of age. - Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol). - HIV-1 infection as documented by HIV-1 RNA >400 copies/mL (c/mL) at Screening and with at least one consecutive HIV-1 RNA >400 c/mL within the four months prior to Screening (unless the Screening HIV-1 RNA is > 1000 c/mL where no additional plasma HIV-1 RNA assessment is needed). - Have documented resistance (via Screening resistance test) to two or more different classes of antiretroviral agents. For subjects off ART for at least one month, if Screening resistance results provide a fully active agent and do not show two class resistance then historical resistance results from the subject's most recent resistance testing may be used, following consultation with the study virologist and /or medical monitor. - Integrase inhibitor (INI)-naïve, defined as no prior exposure to any INI (e.g. RAL, elvitegravir, or GSK1349572). - Able to provide written informed consent prior to Screening. - French subjects: In France, subjects will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. Exclusion Criteria: - Screening resistance test result indicates no fully active antiviral agents are available for design of the background regimen. - Subject-virus does not yield results using genotype/phenotype/tropism at Screening (assay data is essential for eligibility determination). - Women who are breastfeeding. - Any evidence of an active AIDS-defining condition (except cutaneous Kaposi's sarcoma not requiring systemic therapy or CD4+ <200c/mm3). - Subjects with moderate to severe hepatic impairment as defined by Child-Pugh classification. - Recent history (less than or equal to 3 months) of upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding. - Anticipated need for hepatitis C therapy during the study. - History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. - History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma; other localized malignancies require agreement between the investigator and study medical monitor for inclusion of the subject. - Treatment with an HIV-1 immunotherapeutic vaccine within 90 days prior to Screening. - Treatment with any of the following agents within 28 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any immunomodulator. - Treatment with any agent, other than licensed ART, which has documented activity against HIV-1 in vitro within 28 days of first dose of investigational product. - Exposure to an experimental drug and/or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the experimental test agent - whichever is longer, prior to the first dose of IP. - French subjects recruited at sites in France will be excluded if the subject has participated in any study using an investigational drug and/or vaccine within 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine - whichever is longer - prior to screening for the study or the subject plans to participate simultaneously in another clinical study. - Any acute or verified Grade 4 laboratory abnormality. - Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN). - ALT greater than or equal to 3xULN and bilirubin greater than or equal to 1.5xULN (with >35% direct bilirubin).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GSK1349572
50mg once daily
Raltegravir
400mg twice daily
GSK1349572 Placebo
Inactive placebo tablet once daily
Raltegravir Placebo
Inactive placebo tablet twice daily

Locations

Country Name City State
Argentina GSK Investigational Site Buenos Aires
Argentina GSK Investigational Site Ciudad Autonoma de Buenos Aires
Argentina GSK Investigational Site Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina GSK Investigational Site Ciudad Autónoma de Buenos Aires Buenos Aires
Argentina GSK Investigational Site Ciudad de Buenos Aires Buenos Aires
Argentina GSK Investigational Site Rosario Santa Fe
Australia GSK Investigational Site Darlinghurst New South Wales
Australia GSK Investigational Site Melbourne Victoria
Belgium GSK Investigational Site Antwerpen
Belgium GSK Investigational Site Brussels
Belgium GSK Investigational Site Charleroi
Belgium GSK Investigational Site Liege
Brazil GSK Investigational Site Belo Horizonte Minas Gerais
Brazil GSK Investigational Site Curitiba Paraná
Brazil GSK Investigational Site Rio de Janeiro
Brazil GSK Investigational Site Salvador
Brazil GSK Investigational Site Santos
Brazil GSK Investigational Site Sao Paulo São Paulo
Brazil GSK Investigational Site Sao Paulo São Paulo
Brazil GSK Investigational Site São Paulo
Brazil GSK Investigational Site Vitoria
Canada GSK Investigational Site Hamilton Ontario
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Vancouver British Columbia
Chile GSK Investigational Site Puente Alto - Santiago Región Metro De Santiago
Chile GSK Investigational Site Santiago Región Metro De Santiago
Chile GSK Investigational Site Santiago Región Metro De Santiago
Chile GSK Investigational Site Santiago Región Metro De Santiago
Chile GSK Investigational Site Santiago
France GSK Investigational Site Bordeaux
France GSK Investigational Site Garches
France GSK Investigational Site Le Kremlin Bicêtre cedex
France GSK Investigational Site Le Kremlin-Bicêtre Cedex
France GSK Investigational Site Marseille
France GSK Investigational Site Nice
France GSK Investigational Site Orléans
France GSK Investigational Site Paris
France GSK Investigational Site Paris Cedex 10
France GSK Investigational Site Paris Cedex 13
France GSK Investigational Site Paris Cedex 20
France GSK Investigational Site Tourcoing cedex
Greece GSK Investigational Site Athens
Greece GSK Investigational Site Athens
Greece GSK Investigational Site Piraeus
Greece GSK Investigational Site Rio, Patras
Hungary GSK Investigational Site Budapest
Italy GSK Investigational Site Busto Arsizio (VA) Lombardia
Italy GSK Investigational Site Cagliari Sardegna
Italy GSK Investigational Site Milano Lombardia
Italy GSK Investigational Site Modena Emilia-Romagna
Italy GSK Investigational Site Monza Lombardia
Italy GSK Investigational Site Torino Piemonte
Mexico GSK Investigational Site Cuautitlán, Estado De México Estado De México
Mexico GSK Investigational Site Guadalajara Jalisco
Mexico GSK Investigational Site León, Guanajuato Guanajuato
Mexico GSK Investigational Site Mexico City
Netherlands GSK Investigational Site Amsterdam
Netherlands GSK Investigational Site Rotterdam
Poland GSK Investigational Site Chorzow
Romania GSK Investigational Site Bucharest
Romania GSK Investigational Site Bucharest
Romania GSK Investigational Site Constanta
Russian Federation GSK Investigational Site Ekaterinburg
Russian Federation GSK Investigational Site Kazan
Russian Federation GSK Investigational Site Krasnodar
Russian Federation GSK Investigational Site Moscow
Russian Federation GSK Investigational Site Moscow
Russian Federation GSK Investigational Site N.Novgorod
Russian Federation GSK Investigational Site Perm
Russian Federation GSK Investigational Site Ryazan
Russian Federation GSK Investigational Site Saint-Petersburg
Russian Federation GSK Investigational Site Saratov
Russian Federation GSK Investigational Site Toliyatti
Russian Federation GSK Investigational Site Volgograd
South Africa GSK Investigational Site Bloemfontein
South Africa GSK Investigational Site Dundee
South Africa GSK Investigational Site Durban
Spain GSK Investigational Site (Móstoles) Madrid
Spain GSK Investigational Site Alicante
Spain GSK Investigational Site Badalona
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Cartagena (Murcia)
Spain GSK Investigational Site Elche (Alicante)
Spain GSK Investigational Site Granada
Spain GSK Investigational Site Granada
Spain GSK Investigational Site Granollers (Barcelona)
Spain GSK Investigational Site La Coruña
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Mataró
Spain GSK Investigational Site Murcia
Spain GSK Investigational Site Sabadell (Barcelona)
Spain GSK Investigational Site San Sebastián
Spain GSK Investigational Site Sevilla
Spain GSK Investigational Site Sevilla
Spain GSK Investigational Site Valencia
Spain GSK Investigational Site Valencia
Taiwan GSK Investigational Site Kaohsiung
Taiwan GSK Investigational Site Kaohsiung
Taiwan GSK Investigational Site Taichung
Taiwan GSK Investigational Site Taichung
Taiwan GSK Investigational Site Taipei
United Kingdom GSK Investigational Site Crumpsall, Manchester
United Kingdom GSK Investigational Site Liverpool
United Kingdom GSK Investigational Site Tooting, London
United Kingdom GSK Investigational Site Woolwich, London London
United States GSK Investigational Site Akron Ohio
United States GSK Investigational Site Allentown Pennsylvania
United States GSK Investigational Site Annandale Virginia
United States GSK Investigational Site Augusta Georgia
United States GSK Investigational Site Bakersfield California
United States GSK Investigational Site Beverly Hills California
United States GSK Investigational Site Birmingham Alabama
United States GSK Investigational Site Bronx New York
United States GSK Investigational Site Chapel Hill North Carolina
United States GSK Investigational Site Charlotte North Carolina
United States GSK Investigational Site Charlotte North Carolina
United States GSK Investigational Site Chicago Illinois
United States GSK Investigational Site Cincinnati Ohio
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Daytona Beach Florida
United States GSK Investigational Site Detroit Michigan
United States GSK Investigational Site Durham North Carolina
United States GSK Investigational Site Fort Lauderdale Florida
United States GSK Investigational Site Fort Lauderdale Florida
United States GSK Investigational Site Fort Pierce Florida
United States GSK Investigational Site Fort Worth Texas
United States GSK Investigational Site Greenville North Carolina
United States GSK Investigational Site Hillsborough New Jersey
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Indianapolis Indiana
United States GSK Investigational Site Iowa City Iowa
United States GSK Investigational Site Kansas City Missouri
United States GSK Investigational Site Lansing Michigan
United States GSK Investigational Site Little Rock Arkansas
United States GSK Investigational Site Long Beach California
United States GSK Investigational Site Longview Texas
United States GSK Investigational Site Los Angeles California
United States GSK Investigational Site Los Angeles California
United States GSK Investigational Site Los Angeles California
United States GSK Investigational Site Maywood Illinois
United States GSK Investigational Site Minneapolis Minnesota
United States GSK Investigational Site Minneapolis Minnesota
United States GSK Investigational Site Neptune New Jersey
United States GSK Investigational Site New Haven Connecticut
United States GSK Investigational Site New York New York
United States GSK Investigational Site New York New York
United States GSK Investigational Site Newark New Jersey
United States GSK Investigational Site Newark New Jersey
United States GSK Investigational Site Norwalk Connecticut
United States GSK Investigational Site Oakland California
United States GSK Investigational Site Omaha Nebraska
United States GSK Investigational Site Orlando Florida
United States GSK Investigational Site Orlando Florida
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site Phoenix Arizona
United States GSK Investigational Site Portland Oregon
United States GSK Investigational Site Providence Rhode Island
United States GSK Investigational Site Saint Louis Missouri
United States GSK Investigational Site Salt Lake City Utah
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site Savannah Georgia
United States GSK Investigational Site Seattle Washington
United States GSK Investigational Site Spokane Washington
United States GSK Investigational Site Springfield Massachusetts
United States GSK Investigational Site Valhalla New York
United States GSK Investigational Site Washington District of Columbia
United States GSK Investigational Site Washington District of Columbia
United States GSK Investigational Site West Palm Beach Florida
United States GSK Investigational Site Wilton Manors Florida

Sponsors (3)

Lead Sponsor Collaborator
ViiV Healthcare GlaxoSmithKline, Shionogi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Chile,  France,  Greece,  Hungary,  Italy,  Mexico,  Netherlands,  Poland,  Romania,  Russian Federation,  South Africa,  Spain,  Taiwan,  United Kingdom, 

References & Publications (1)

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. Erratum in: Lancet. 2014 Jan 4;383(9911):30. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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. Baseline (Day 1); Weeks 4, 8, 12, 16, 24, 32, 40, and 48
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. At Week 48
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. Baseline (Day 1) until PDVF (Up to Week 48)
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. At Week 24
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. At Week 24 and Week 48
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). Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144
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. Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144
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. Up to Week 480
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. 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
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. From Week 48 to Week 480
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. 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
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. Pre-dose at Weeks 4, 24 and 48
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. 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
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. Baseline (Day 1) and at Weeks 24 and 48
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. Baseline (Day 1) and at Weeks 24 and 48
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