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Result Summaries: dolutegravir

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Study ID
   Phase    Title Summary (Download)
111405 phase 1 A Phase I, open label, randomized, two period, one-way two sequence crossover study to evaluate the effect of darunavir/ritonavir and lopinavir/ritonavir on GSK1349572 pharmacokinetics in healthy adult subjects (ING111405). (1 citation(s)) Click here to download result summary.
111521 Phase 2 A Phase 2a, Multicenter, Randomized, Parallel, Double-Blind, Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK1349572 Monotherapy Versus Placebo Over 10 days in HIV-1 Infected Adults (ING111521) (1 citation(s))
111602 phase 1 A Phase I, open label, randomized, four-period crossover studyto evaluate the effects of Maalox® Advanced Maximum Strengthand One A Day® Maximum on pharmacokinetics of GSK1349572in healthy adult subjects (2 citation(s)) Click here to download result summary.
111603 phase 1 A Phase I, open label, two period, single fixed-sequence crossover study to evaluate the effect of etravirine on GSK1349572 pharmacokinetics in healthy adult subjects (ING111603) (1 citation(s)) Click here to download result summary.
111604 phase 1 A Phase I, Open Label, Single Sequence,Drug Interaction Study Evaluating Plasma GSK1349572 and Tenofovir Pharmacokinetics in Healthy Adult Subjects (ING111604) (1 citation(s)) Click here to download result summary.
111762 phase 3 A Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered with an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral-Experienced Adults (1 citation(s)) Click here to download result summary.
111853 phase 1 An Open Label, Non-Randomized, Single dose, Mass Balance Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK1349572 20 mg, Administered as a Single Oral Suspension Dose to Healthy Adult Subjects (ING111853) (1 citation(s)) Click here to download result summary.
111854 phase 1 Phase I, Open Label, Randomized, Drug-Drug Interaction Study in Healthy Subjects to Investigate the Effects of Co-administered Atazanavir/Ritonavir (300mg/100mg) or Atazanavir 400mg Administered Once Daily on the Steady-State Plasma Pharmacokinetics of GSK1349572 30mg Administered Once Daily (1 citation(s)) Click here to download result summary.
111855 phase 1 A Double-Blind study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Norgestimate and Ethinyl Estradiol when Co-administered with Dolutegravir in Healthy Adult Female Subjects (1 citation(s)) Click here to download result summary.
111856 phase 1 A Study to Evaluate the Effect of a Single 250 mg Oral Dose of GSK1349572 on Cardiac Conduction as Assessed by 12-lead Electrocardiogram Compared to Placebo and a Single Oral Dose of Moxifloxacin (ING111856). (1 citation(s)) Click here to download result summary.
112276 phase 2 A Phase IIb study to select a once daily dose of GSK1349572 administered with either abacavir/lamivudine or tenofovir/emtricitabine in HIV-1 infected antiretroviral therapy naive adult subjects (1 citation(s)) Click here to download result summary.
112574 Phase 3 A Phase III study to demonstrate the antiviral activity and safety of dolutegravir in HIV-1 infected adult subjects with treatment failure on an integrase inhibitor containing regimen. (1 citation(s))
112934 phase 1 A Phase I, open label, randomized, three period, one-way, two cohort, adaptive crossover study to evaluate the effect of darunavir/ritonavir plus etravirine and lopinavir/ritonavir plus etravirine on GSK1349572 pharmacokinetics in healthy adult subjects (ING112934) (1 citation(s)) Click here to download result summary.
112941 phase 1 The official study title exceeds the 300 character limit for this field. See Detailed Study Description Section for official study title. (2 citation(s)) Click here to download result summary.
112961 phase 2 A pilot study to assess the antiviral activity of GSK1349572 containing regimen in antiretroviral therapy (ART)-experienced, HIV-1-infected adult subjects with raltegravir resistance (1 citation(s)) Click here to download result summary.
113068 phase 1 Phase I, Open Label, Two Period Study to Evaluate the Effects of Fosamprenavir/Ritonavir on GSK1349572 Pharmacokinetics and a Phase I, Randomized, Three-Way Crossover Study to Evaluate the Relative Bioavailability of Three Tablet Variants made using Micronized, Unmicronized and Intermediate Particle Sizes of GSK1349572 in Healthy Adult Subjects (0 citation(s))
113086 phase 3 A randomized, double blind study of the safety and efficacy of GSK1349572 50mg once daily to raltegravir 400mg twice daily both administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral therapy naive adult subjects (2 citation(s)) Click here to download result summary.
113096 Phase 1 An Open-Label, Single Sequence, Three-Period Drug Interaction Study of GSK1349572 and Tipranavir/Ritonavir in Healthy Adult Subjects (ING113096) (1 citation(s))
113097 Phase 1 A Phase I, Open-Label, Parallel-Group, Two-Part, Adaptive Study to Evaluate the Pharmacokinetics and Safety of GSK1349572 in Subjects with Hepatic Impairment and Healthy Matched Control Subjects (ING113097) (1 citation(s))
113099 phase 1 Phase 1, open label, two arm, fixed sequence study to evaluate the effect of rifampin and rifabutin on GSK1349572 pharmacokinetics in healthy male and female volunteers (1 citation(s)) Click here to download result summary.
113125 Phase 1 A Phase I, Open-Label, Parallel-Group Study to Evaluate the Pharmacokinetics and Safety of Dolutegravir in Subjects with Renal Impairment and Healthy Matched Control Subjects (ING113125) (1 citation(s))
113674 phase 1 Relative bioavailability study of three different tablet formulations of GSK1349572 50 mg and the Dose Proportionality of and Effect of Food on the Selected Formulation in healthy male and female volunteers (ING113674) (1 citation(s)) Click here to download result summary.
114005 Phase 1 A Phase 1, Open Label, Single Sequence, Three Period Study to Evaluate the Single Dose Pharmacokinetics of GSK1349572 100mg versus 50mg and the Effect of Efavirenz 600mg Once Daily on the Pharmacokinetics, Safety and Tolerability of GSK1349572 50mg Once Daily in Healthy Adult Subjects (ING114005) (1 citation(s))
114467 phase 3 A Randomized, Double-Blind Study of the Safety and Efficacy of GSK1349572 Plus Abacavir/Lamivudine Fixed-Dose Combination Therapy Administered Once Daily Compared to Atripla over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects (1 citation(s)) Click here to download result summary.
114556 Phase 1 Relative bioavailability study of a tablet formulation vs. pediatric granule formulation of Dolutegravir 50 mg and Effect of Different Types of Water plus Infant Formula on the Pediatric Granule Formulation in healthy male and female volunteers (1 citation(s))
114580 Phase 1 An Evaluation of the Bioequivalence of a Combined Formulated Tablet (50mg/600mg/300mg dolutegravir/abacavir/lamivudine)Compared to One Dolutegravir 50mg Tablet and One EPZICOM† (600mg/300mg abacavir/lamivudine) Tablet Administered Concurrently and the Effect of Food on Bioavailability of the Combined Formulation in Healthy Adult Subjects (2 citation(s))
114581 phase 1 A Randomized, Open-Label, Single‑Dose, 3‑Period, Crossover Evaluation of the Relative Bioavailability of Two Experimental Fixed-Dose Combination Tablet Formulations of Dolutegravir 50 mg/Abacavir 600 mg/Lamivudine 300 mg Compared to Co‑administered Dolutegravir 50 mg and EPZICOM™ (Abacavir 600 mg/Lamivudine 300 mg) Tablets in Healthy Adult Subjects (0 citation(s)) Click here to download result summary.
114819 phase 1 A Phase 1, Open Label, Placebo-Controlled Study to Evaluate the Effect of GSK1349572 on Iohexol and Para-Aminohippurate Clearance in Healthy Subjects (1 citation(s)) Click here to download result summary.
114915 phase 3 A Phase IIIb, randomized, open-label study of the safety and efficacy of GSK1349572 (dolutegravir, DTG) 50 mg once daily compared to darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily each administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral naïve adult subjects (0 citation(s))
115381 phase 1 An Open-Label, Single Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of GSK1349572 (dolutegravir, DTG) in Healthy Japanese Subjects (1 citation(s)) Click here to download result summary.
115696 phase 1 An Adaptive, Two part, Two period, Single Sequence, Drug Interaction Study between Dolutegravir 50 mg and Prednisone in Adult Healthy Volunteers (1 citation(s)) Click here to download result summary.
115697 phase 1 A Phase I, open label, randomized, two cohort, two period, oneway study to evaluate the effect of Boceprevir and Telaprevir onDolutegravir pharmacokinetics in healthy adult subjects (ING115697) (1 citation(s))
115698 phase 1 A Phase 1, Open-Label, 2-Period Drug Interaction Study to Assess Steady State Plasma Methadone Enantiomer Pharmacokinetics Following Co-Administration of Methadone QD with Dolutegravir (GSK1349572) 50 mg twice daily in Opiate-Dependent, HIV Seronegative Adult Subjects. (1 citation(s)) Click here to download result summary.
116070 Phase 3 A Single-arm Study of the Safety, Efficacy and Central Nervous System and Plasma PK of GSK1349572 (Dolutegravir, DTG) 50 mg Once Daily in Combination with the Abacavir/Lamivudine Fixed Dose Combination Tablet over 96 Weeks in HIV-1 Infected Antiretroviral Naive Adult Subjects (2 citation(s))
116265 N/A PGx432 evaluation of the effect of UGT1A1 polymorphisms on dolutegravir pharmacokinetics: meta-analysis of Phase 1 studies ING111521, ING111603, ING111604, ING112934, ING113068, ING113096, ING114005, ING114819, ING113099 (1 citation(s))
116529 phase 3 A Phase III Randomized, Double-blind Trial Investigating the Activity of Dolutegravir 50 mg BID vs Placebo over 7 Days in HIV-1-infected Subjects with RAL/ELV resistance, Followed by an Open-label Phase with an Optimized Background Regimen (0 citation(s)) Click here to download result summary.
116898 phase 1 A Phase I, Open Label, Randomized, Four-Period Crossover Study to Evaluate the Effects of Calcium Carbonate 1200 mg and Ferrous Fumarate 324 mg on Pharmacokinetics of Dolutegravir 50 mg in Healthy Adult Subjects (1 citation(s)) Click here to download result summary.
200401 Phase 1 A Phase 1, Single Dose, Crossover, Relative Bioavailability Study of a Dolutegravir Dispersible Tablet as Compared to a Dolutegravir Pediatric Granule Formulation and Effect of Different Types of Water on the Dispersible Tablet in Healthy Volunteers(200401) (0 citation(s)) Click here to download result summary.
200901 Phase 1 A Phase I, Open label, Randomized, Three period, Fixed Sequence Crossover study to Evaluate the Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects (200901) (0 citation(s)) Click here to download result summary.
201102 Phase 1 A Phase 1, Open-Label, Crossover Study to Evaluate the Drug Interaction Between Dolutegravir and Daclatasvir in Healthy Adult Subjects (0 citation(s)) Click here to download result summary.
201167 Phase 1 A Phase I, open label, parallel group, three period, fixed sequence crossover study to evaluate the effect of dolutegravir on metformin pharmacokinetics in healthy adult subjects (0 citation(s)) Click here to download result summary.
201398 N/A An Exploratory Meta-Analysis of the Efficacy of Dolutegravir across Subgroups (0 citation(s)) Click here to download result summary.
201674 Phase 1 A Phase I, 2-part relative oral bioavailability study of different fixed dose combinations of dolutegravir and rilpivirine in fasted and fed healthy subjects (0 citation(s)) Click here to download result summary.
204993 Phase 1 A Phase I, relative oral bioavailability study of different fixed dose combinations of dolutegravir and lamivudine in healthy subjects (0 citation(s)) Click here to download result summary.
205817 Phase 4 A Comparative Analysis of Regimen Durability and Virologic Outcomes in Female Patients taking Integrase Strand Transfer Inhibitors in the OPERA® Observational Database (0 citation(s)) Click here to download result summary.
205846 Phase 1 PRJ2693: Descriptive Analysis of Neuropsychiatric Diagnoses in Patients taking Dolutegravir in the OPERA® Observational Database (0 citation(s)) Click here to download result summary.
206254 Phase 4 Pregnancy and Neonatal Outcomes following Prenatal Exposure to Dolutegravir: Data from the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) (0 citation(s)) Click here to download result summary.
ING111207 phase 1 A Double-Blind, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK1349572 in Healthy Subjects (1 citation(s)) Click here to download result summary.
ING111322 phase 1 GSK1349572 Repeat Dose Escalation Study (1 citation(s)) Click here to download result summary.