A Phase 3 interventional study of GSK1349572 (dolutegravir) and raltegravir in Infection, Human Immunodeficiency Virus I, sponsored by ViiV Healthcare. Completed at 101 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-09.
Sponsored by ViiV Healthcare · Phase 3, Interventional, and Treatment
The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested at Week 96. Both GSK1349572 and RAL will be given in combination with fixed-dose dual NRTI therapy (ABC/3TC or TDF/FTC). This study will be conducted in HIV-1 infected ART-naïve adult subjects.
ING113086 is a Phase 3 randomized, double-blind, double dummy, active-controlled, multicenter, study conducted in approximately 788 HIV-1 infected ART-naïve subjects. Subjects will be randomized 1:1 one of the following treatment arms:
GSK1349572 50 mg once daily (approximately 394 subjects) + fixed-dose dual NRTI therapy (either ABC/3TC or TDF/FTC)
OR
Analyses will be conducted at 48 weeks and 96 weeks. Subjects randomized to receive GSK1349572 and who successfully complete 96 weeks of treatment will continue to have access to GSK1349572 through the study until either it is locally available, as long as they continue to derive clinical benefit.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship
2,041 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 828 is above the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →ViiV Healthcare is the lead sponsor of 261 studies on the registry; 16 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 50 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
GSK1349572 50mg once daily + raltegravir placebo twice daily + NRTI background therapy once daily
Drug: GSK1349572 (dolutegravir) · Other: GSK1349572 Placebo · Other: ABC/3TC · Other: TDF/FTC
raltegravir 400mg twice daily + GSK1349572 placebo once daily + NRTI background therapy once daily
Drug: raltegravir · Other: ABC/3TC · Other: TDF/FTC · Other: raltegravir Placebo
GSK1349572 50 mg taken once daily with or without food
raltegravir 400mg taken twice daily
GSK1349572 placebo taken once daily
Abacavir/Lamivudine background therapy once daily
Tenofovir/emtricitabine background therapy once daily
raltegravir placebo taken twice daily
Percentage of Participants With Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) [HIV-1RNA] <50 Copies (c)/Milliliter (mL) Through Week 48
Percentage of participants with plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) with \<50 c/mL was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. The algorithm treats all participants without HIV-1 RNA data as non-responders, as well as participants who switch their concomitant Antiretroviral Therapy (ART) prior to Week 48 as follows: background ART substitutions not permitted per study; background ART substitutions permitted per study 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 will be determined by the last available HIV-1 RNA assessment while the subject was on-treatment. Intent-to-Treat Exposed (ITT-E) Population comprised all randomized participants who received at least one dose of study medication.
Time frame: Baseline up to Week 48
Number of Participants With Detectable HIV-1 Virus That Has Genotypic or Phenotypic Evidence of INI Resistance.
Number of participants with detectable virus that has genotypic or phenotypic evidence of Integrase Inhibitor (INI) resistance were assessed at Week 48 and Week 96. Integrase inhibitors are a class of antiretroviral drug designed to block the action of integrase, a viral enzyme that inserts the viral genome into the deoxyribonucleic acid (DNA) of the host cell.
Time frame: Week 48 and Week 96
Number of Participants With Plasma HIV-1 RNA <50 c/mL
The number of participants with plasma HIV-1 RNA level \<50 c/mL was assessed at Week 96.
Time frame: Week 96
Number of Participants With Plasma HIV-1 RNA <400 c/mL
The number of participants with plasma HIV-1 RNA level \<400 c/mL was assessed at Week 48 and Week 96.
Time frame: Week 48 and Week 96
Change From Baseline in Plasma HIV-1 RNA Over Time
Change from Baseline in plasma HIV-1 RNA over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Baseline was defined as the measurements performed on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).
Time frame: Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96
Absolute Values in Plasma HIV-1 RNA Over Time
Absolute values in plasma HIV-1 RNA over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).
Time frame: Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96
Change From Baseline in Cluster of Differentiation (CD)4+ Cell Counts Over Time
CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immuno compromise. The CD4 count is used to stage the participants disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start ART. Changes from Baseline in CD4+ cell counts over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Baseline was defined as measurements performed on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).
Time frame: Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96
Absolute Values in CD4+ Cell Counts Over Time
CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immuno compromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy absolute values in CD4+ cell counts over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).
Time frame: Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96
Number of Participants With the Indicated Post-Baseline HIV-associated Conditions and Progression, Excluding Recurrences
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 the 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 a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline to a CDC CAT C event (EV); CDC CAT B at Baseline to a CDC CAT C EV; CDC CAT C at Baseline to a new CDC CAT C EV; or CDC CAT A, B, or C at Baseline to death.
Time frame: From Baseline until Week 96
Number of Participants With the Indicated Grade 1 to 4 Clinical Chemistry and Hematology Toxicities/Laboratory Adverse Events (AEs)
All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), 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, phosphorus inorganic, 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. Safety Population: all participants who received at least one dose of investigational product
Time frame: From Baseline until Week 96
Area Under the Plasma Concentration-time Curve From Time Zero to Time Tau [AUC(0-tau)] of DTG
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. The predicted individual AUC(0-tau) were obtained from the final population PK model by an empirical Bayes estimation. Blood samples for PK assessments were collected at pre-dose (within 15 minutes prior to dose) at Week 4, Week 24, and Week 48 and 1 to 3 hours post-dose or 4 to 12 hours post-dose at Week 4 and Week 24. If 1 to 3 hours post-dose was completed at Week 4, then the 4 to12 hour post-dose must be obtained at Week 48, and vice versa. The Pharmacokinetic (PK) Concentration Population comprised of all participants who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.
Time frame: Week 4, Week 24, and Week 48
Maximum Plasma Concentration (Cmax) and Concentration at the End of a Dosing Interval (Ctau) of DTG
The maximum plasma concentration (Cmax) and concentration at the end of a dosing interval (Ctau) of DTG were assessed at Week 48. The predicted individual Cmax and Ctau were obtained from the final population PK model by simulation of the concentration-time profiles. Blood samples for PK assessments were collected at pre-dose (within 15 minutes prior to dose) at Week 4, Week 24, and Week 48 and 1 to 3 hours post-dose or 4 to 12 hours post-dose at Week 4 and Week 24. If 1 to 3 hour post-dose was completed at Week 4, then the 4 to12 hour post-dose must be obtained at Week 48, and vice versa.
Time frame: Week 4, Week 24, and Week 48
This was a randomized, parallel group, non-inferiority study to demonstrate the antiviral activity of Dolutegravir. Participants were enrolled from 9 countries. Participants in Dolutegravir arm who completed 96 Weeks double-blind phase continued to receive Dolutegravir in open-label phase, until dolutegravir was locally available commercially.
| Milestone | DTG 50 mg Once a Day | RTG 400 mg BID | DTG 50 mg Once a Day (Open-label) |
|---|---|---|---|
| Started | 411 | 411 | 0 |
| Completed | 304 | 332 | 0 |
| Not completed | 107 | 79 | 0 |
| Withdrew: Adverse event | 12 | 7 | 0 |
| Withdrew: Lack of efficacy | 22 | 25 | 0 |
| Withdrew: Protocol violation | 18 | 16 | 0 |
| Withdrew: Met protocol-defined stopping criteria | 6 | 3 | 0 |
| Withdrew: Study closed/terminated | 6 | 4 | 0 |
| Withdrew: Lost to follow-up | 22 | 10 | 0 |
| Withdrew: Withdrawal by subject | 18 | 14 | 0 |
| Withdrew: Physician decision | 3 | 0 | 0 |
| Milestone | DTG 50 mg Once a Day | RTG 400 mg BID | DTG 50 mg Once a Day (Open-label) |
|---|---|---|---|
| Started | 0 | 0 | 338 |
| Completed | 0 | 0 | 294 |
| Not completed | 0 | 0 | 44 |
| Withdrew: Adverse event | 0 | 0 | 4 |
| Withdrew: Lack of efficacy | 0 | 0 | 5 |
| Withdrew: Protocol violation | 0 | 0 | 5 |
| Withdrew: Met protocol-defined stopping criteria | 0 | 0 | 4 |
| Withdrew: Lost to follow-up | 0 | 0 | 15 |
| Withdrew: Withdrawal by subject | 0 | 0 | 8 |
| Withdrew: Physician decision | 0 | 0 | 3 |
Percentage of participants with plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) with \<50 c/mL was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. The algorithm treats all participants without HIV-1 RNA data as non-responders, as well as participants who switch their concomitant Antiretroviral Therapy (ART) prior to Week 48 as follows: background ART substitutions not permitted per study; background ART substitutions permitted per study 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 will be determined by the last available HIV-1 RNA assessment while the subject was on-treatment. Intent-to-Treat Exposed (ITT-E) Population comprised all randomized participants who received at least one dose of study medication.
| Percentage of participants | DTG 50 mg Once a Day | RTG 400 mg BID |
|---|---|---|
| Percentage of Participants With Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) [HIV-1RNA] <50 Copies (c)/Milliliter (mL) Through Week 48 | 88 | 85 |
Number of participants with detectable virus that has genotypic or phenotypic evidence of Integrase Inhibitor (INI) resistance were assessed at Week 48 and Week 96. Integrase inhibitors are a class of antiretroviral drug designed to block the action of integrase, a viral enzyme that inserts the viral genome into the deoxyribonucleic acid (DNA) of the host cell.
| Participants | DTG 50 mg Once a Day | RTG 400 mg BID |
|---|---|---|
| Week 48, genotypic | 0 | 1 |
| Week 48, phenotypic | 1 | 2 |
| Week 96, genotypic | 0 | 1 |
| Week 96, phenotypic | 1 | 2 |
The number of participants with plasma HIV-1 RNA level \<50 c/mL was assessed at Week 96.
| Participants | DTG 50 mg Once a Day | RTG 400 mg BID |
|---|---|---|
| Number of Participants With Plasma HIV-1 RNA <50 c/mL | 332 | 314 |
The number of participants with plasma HIV-1 RNA level \<400 c/mL was assessed at Week 48 and Week 96.
| Participants | DTG 50 mg Once a Day | RTG 400 mg BID |
|---|---|---|
| Week 48 | 369 | 356 |
| Week 96 | 338 | 321 |
Change from Baseline in plasma HIV-1 RNA over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Baseline was defined as the measurements performed on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).
| log10 c/mL | DTG 50 mg Once a Day | RTG 400 mg BID |
|---|---|---|
| Baseline n=411, 411 | 4.538 ± 0.7258 | 4.599 ± 0.7048 |
| Week 4, n=402, 406 | -2.817 ± 0.6198 | -2.801 ± 0.6041 |
| Week 8, n=397, 402 | -2.897 ± 0.6837 | -2.886 ± 0.6754 |
| Week 12, n=396, 395 | -2.908 ± 0.6863 | -2.918 ± 0.6834 |
| Week 16, n=395, 388 | -2.917 ± 0.6949 | -2.943 ± 0.6841 |
| Week 24, n=393, 390 | -2.896 ± 0.7889 | -2.933 ± 0.7398 |
| Week 32, n=386, 377 | -2.907 ± 0.7609 | -2.947 ± 0.7613 |
| Week 40, n=375, 358 | -2.920 ± 0.7219 | -2.946 ± 0.6700 |
| Week 48, n=374, 358 | -2.915 ± 0.7237 | -2.942 ± 0.6737 |
| Week 60, n=366, 355 | -2.912 ± 0.7344 | -2.937 ± 0.6685 |
| Week 72, n=361, 350 | -2.917 ± 0.7261 | -2.932 ± 0.6728 |
| Week 84, n=352, 338 | -2.932 ± 0.7073 | -2.916 ± 0.6646 |
| Week 96, n=342, 329 | -2.938 ± 0.7004 | -2.901 ± 0.7072 |
Absolute values in plasma HIV-1 RNA over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).
| log10 c/mL | DTG 50 mg Once a Day | RTG 400 mg BID |
|---|---|---|
| Baseline n=411, 411 | 4.538 ± 0.7258 | 4.599 ± 0.7048 |
| Week 4, n=402, 406 | 1.718 ± 0.2593 | 1.800 ± 0.4095 |
| Week 8, n=397, 402 | 1.646 ± 0.2006 | 1.709 ± 0.3791 |
| Week 12, n=396, 395 | 1.626 ± 0.1323 | 1.672 ± 0.3125 |
| Week 16, n=395, 388 | 1.620 ± 0.1252 | 1.648 ± 0.2647 |
| Week 24, n=393, 390 | 1.643 ± 0.2950 | 1.655 ± 0.3476 |
| Week 32, n=386, 377 | 1.620 ± 0.1917 | 1.636 ± 0.2721 |
| Week 40, n=375, 358 | 1.603 ± 0.0821 | 1.601 ± 0.0784 |
| Week 48, n=374, 358 | 1.606 ± 0.0866 | 1.599 ± 0.0582 |
| Week 60, n=366, 355 | 1.605 ± 0.1134 | 1.599 ± 0.0560 |
| Week 72, n=361, 350 | 1.601 ± 0.0803 | 1.605 ± 0.0836 |
| Week 84, n=352, 338 | 1.607 ± 0.1337 | 1.614 ± 0.1279 |
| Week 96, n=342, 329 | 1.599 ± 0.830 | 1.630 ± 0.2515 |
CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immuno compromise. The CD4 count is used to stage the participants disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start ART. Changes from Baseline in CD4+ cell counts over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Baseline was defined as measurements performed on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).
| Cells per cubic millimeter (cells/mm^3) | DTG 50 mg Once a Day | RTG 400 mg BID |
|---|---|---|
| Baseline n=411, 411 | 379.2 ± 178.32 | 374.3 ± 163.37 |
| Week 4, n=398, 403 | 93.3 ± 116.27 | 97.2 ± 129.35 |
| Week 8, n=398, 402 | 121.6 ± 127.97 | 126.6 ± 134.59 |
| Week 12, n=392, 397 | 130.7 ± 131.49 | 145.1 ± 144.08 |
| Week 16, n=394, 392 | 155.1 ± 137.23 | 173.0 ± 159.10 |
| Week 24, n=392, 389 | 199.3 ± 161.23 | 204.2 ± 162.28 |
| Week 32, n=384, 375 | 223.4 ± 165.30 | 241.3 ± 167.64 |
| Week 40, n=371, 357 | 224.1 ± 173.59 | 239.8 ± 173.33 |
| Week 48, n=374, 357 | 238.9 ± 171.81 | 257.5 ± 178.69 |
| Week 60, n=367, 355 | 247.8 ± 184.11 | 264.2 ± 188.63 |
| Week 72, n=360, 350 | 247.8 ± 168.37 | 278.6 ± 182.76 |
| Week 84, n=351, 338 | 281.3 ± 175.07 | 292.9 ± 199.42 |
| Week 96, n=343, 328 | 292.2 ± 195.70 | 286.2 ± 192.45 |
CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immuno compromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy absolute values in CD4+ cell counts over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).
| cells/mm^3 | DTG 50 mg Once a Day | RTG 400 mg BID |
|---|---|---|
| Baseline n=411, 411 | 379.2 ± 172.32 | 374.3 ± 163.37 |
| Week 4, n=398, 403 | 474.2 ± 199.06 | 471.8 ± 191.02 |
| Week 8, n=398, 402 | 502.3 ± 205.15 | 502.4 ± 187.99 |
| Week 12, n=392, 397 | 513.3 ± 218.75 | 518.3 ± 195.59 |
| Week 16, n=394, 392 | 536.4 ± 219.47 | 550.1 ± 221.77 |
| Week 24, n=392, 389 | 582.0 ± 232.93 | 580.8 ± 218.76 |
| Week 32, n=384, 375 | 606.5 ± 242.95 | 618.7 ± 237.56 |
| Week 40, n=371, 357 | 609.1 ± 239.11 | 623.1 ± 234.82 |
| Week 48, n=374, 357 | 623.8 ± 247.82 | 641.2 ± 241.75 |
| Week 60, n=367, 355 | 635.6 ± 241.27 | 648.5 ± 238.99 |
| Week 72, n=360, 350 | 635.2 ± 237.78 | 664.0 ± 239.86 |
| Week 84, n=351, 338 | 668.0 ± 246.50 | 677.5 ± 249.64 |
| Week 96, n=343, 328 | 679.8 ± 257.89 | 672.4 ± 237.54 |
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 the 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 a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline to a CDC CAT C event (EV); CDC CAT B at Baseline to a CDC CAT C EV; CDC CAT C at Baseline to a new CDC CAT C EV; or CDC CAT A, B, or C at Baseline to death.
| Participants | DTG 50 mg Once a Day | RTG 400 mg BID |
|---|---|---|
| Any category condition | 10 | 8 |
| Any Category B condition | 3 | 3 |
| Any Category C condition | 6 | 4 |
| Any death | 1 | 1 |
| Progression from CAT A to CAT C | 4 | 2 |
| Progression from CAT B to CAT C | 3 | 1 |
| Progression from CAT C to new CAT C | 0 | 1 |
| Progression from CAT A, B, or C to death | 1 | 1 |
All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), 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, phosphorus inorganic, 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. Safety Population: all participants who received at least one dose of investigational product
| Participants | DTG 50 mg Once a Day | RTG 400 mg BID |
|---|---|---|
| ALT | 57 | 70 |
| ALP | 7 | 15 |
| AST | 67 | 75 |
| CO2 content/bicarbonate | 58 | 67 |
| Cholesterol | 90 | 73 |
| CK | 61 | 47 |
| Creatinine | 11 | 7 |
| Hyperglycaemia | 70 | 87 |
| Hyperkalemia | 7 | 4 |
| Hypernatremia | 4 | 6 |
| Hypoglycaemia | 17 | 27 |
| Hypokalemia | 10 | 15 |
| Hyponatremia | 34 | 48 |
| LDL cholesterol calculation | 74 | 49 |
| Lipase | 55 | 62 |
| Phosphorus, inorganic | 65 | 71 |
| Total bilirubin | 27 | 24 |
| Triglycerides | 7 | 8 |
| Hemoglobin | 10 | 5 |
| Platelet count | 19 | 19 |
| Total neutrophils | 54 | 48 |
| White Blood Cell count | 19 | 7 |
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. The predicted individual AUC(0-tau) were obtained from the final population PK model by an empirical Bayes estimation. Blood samples for PK assessments were collected at pre-dose (within 15 minutes prior to dose) at Week 4, Week 24, and Week 48 and 1 to 3 hours post-dose or 4 to 12 hours post-dose at Week 4 and Week 24. If 1 to 3 hours post-dose was completed at Week 4, then the 4 to12 hour post-dose must be obtained at Week 48, and vice versa. The Pharmacokinetic (PK) Concentration Population comprised of all participants who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.
| Micrograms*hour per milliliter(µg*hr/mL) | DTG 50 mg Once a Day | RTG 400 mg BID |
|---|---|---|
| Area Under the Plasma Concentration-time Curve From Time Zero to Time Tau [AUC(0-tau)] of DTG | 53.6 ± 26.8 | — |
The maximum plasma concentration (Cmax) and concentration at the end of a dosing interval (Ctau) of DTG were assessed at Week 48. The predicted individual Cmax and Ctau were obtained from the final population PK model by simulation of the concentration-time profiles. Blood samples for PK assessments were collected at pre-dose (within 15 minutes prior to dose) at Week 4, Week 24, and Week 48 and 1 to 3 hours post-dose or 4 to 12 hours post-dose at Week 4 and Week 24. If 1 to 3 hour post-dose was completed at Week 4, then the 4 to12 hour post-dose must be obtained at Week 48, and vice versa.
| Micrograms per milliliter (µg/mL) | DTG 50 mg Once a Day | RTG 400 mg BID |
|---|---|---|
| Cmax | 3.69 ± 19.6 | — |
| Ctau | 1.10 ± 46.5 | — |
Collected over Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the study (up to a median of 1267 days).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DTG 50 mg Once a Day | 1/411 (0.2%) | 41/411 (10%) | 353/411 (85.9%) |
| RTG 400mg BID | 1/411 (0.2%) | 45/411 (10.9%) | 344/411 (83.7%) |
| DTG 50 mg Once a Day (Open-label) | 0/338 (0%) | 21/338 (6.2%) | 256/338 (75.7%) |
| Event | DTG 50 mg Once a Day | RTG 400mg BID | DTG 50 mg Once a Day (Open-label) |
|---|---|---|---|
| AppendicitisInfections and infestations | 2/411 | 5/411 | 1/338 |
| Suicide attemptPsychiatric disorders | 2/411 | 3/411 | 1/338 |
| Drug hypersensitivityImmune system disorders | 3/411 | 0/411 | 1/338 |
| SyphilisInfections and infestations | 0/411 | 0/411 | 2/338 |
| PneumoniaInfections and infestations | 0/411 | 2/411 | 1/338 |
| LacerationInjury, poisoning and procedural complications | 0/411 | 2/411 | 0/338 |
| SeizureNervous system disorders | 0/411 | 2/411 | 0/338 |
| Suicidal ideationPsychiatric disorders | 0/411 | 2/411 | 0/338 |
| Anal abscessInfections and infestations | 0/411 | 1/411 | 1/338 |
| Diabetes mellitus inadequate controlMetabolism and nutrition disorders | 1/411 | 0/411 | 1/338 |
| Event | DTG 50 mg Once a Day | RTG 400mg BID | DTG 50 mg Once a Day (Open-label) |
|---|---|---|---|
| NauseaGastrointestinal disorders | 60/411 | 55/411 | 3/338 |
| DiarrhoeaGastrointestinal disorders | 58/411 | 54/411 | 21/338 |
| HeadacheNervous system disorders | 56/411 | 55/411 | 9/338 |
| Viral upper respiratory tract infectionInfections and infestations | 54/411 | 54/411 | 24/338 |
| Upper respiratory tract infectionInfections and infestations | 34/411 | 31/411 | 27/338 |
| SyphilisInfections and infestations | 24/411 | 28/411 | 24/338 |
| InsomniaPsychiatric disorders | 28/411 | 19/411 | 6/338 |
| Back painMusculoskeletal and connective tissue disorders | 24/411 | 26/411 | 10/338 |
| DepressionPsychiatric disorders | 26/411 | 18/411 | 8/338 |
| SinusitisInfections and infestations | 25/411 | 16/411 | 12/338 |
| Age, Continuous(Years) | DTG 50 mg Once a Day | RTG 400 mg BID | Total |
|---|---|---|---|
| Mean | 37.3 ± 9.19 | 36.6 ± 10.02 | 37.0 ± 9.61 |
| Sex: Female, Male(Participants) | DTG 50 mg Once a Day | RTG 400 mg BID | Total |
|---|---|---|---|
| Female | 63 | 56 | 119 |
| Male | 348 | 355 | 703 |
| Race/Ethnicity, Customized(Participants) | DTG 50 mg Once a Day | RTG 400 mg BID | Total |
|---|---|---|---|
| African American/African Heritage (Her) | 49 | 39 | 88 |
| American Indian or Alaska Native | 7 | 9 | 16 |
| Central/South Asian Her | 2 | 0 | 2 |
| Japanese/East Asian Her/South East Asian Her | 4 | 10 | 14 |
| Native Hawaiian or other Pacific Islander | 2 | 0 | 2 |
| White | 346 | 352 | 698 |
| African American/African Her and Asian and White | 1 | 0 | 1 |
| Asian and White | 0 | 1 | 1 |
Showing the first 100 of 101 sites across 9 countries.
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