Quick Search


 

Protocol Summaries: dolutegravir

ViiV
Study ID
   Phase    Title Status
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). Completed
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) Completed
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 Completed
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) Completed
111604 phase 1 A Phase I, Open Label, Single Sequence,Drug Interaction Study Evaluating Plasma GSK1349572 and Tenofovir Pharmacokinetics in Healthy Adult Subjects (ING111604) Completed
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 Active not recruiting
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) Completed
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 Completed
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 Completed
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). Completed
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 Completed
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. Completed
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) Completed
112941 phase 1 The official study title exceeds the 300 character limit for this field. See Detailed Study Description Section for official study title. Completed
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 Completed
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 Completed
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 Active not recruiting
113096 Phase 1 An Open-Label, Single Sequence, Three-Period Drug Interaction Study of GSK1349572 and Tipranavir/Ritonavir in Healthy Adult Subjects (ING113096) Completed
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) Completed
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 Completed
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) Completed
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) Completed
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) Completed
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 Completed
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 Completed
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 Completed
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 Completed
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 Completed
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 Completed
114916 phase 3 A Dolutegravir Open Label Protocol for HIV infected, Adult and Adolescent Patients with Integrase Resistance Recruiting
115381 phase 1 An Open-Label, Single Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of GSK1349572 (dolutegravir, DTG) in Healthy Japanese Subjects Completed
115696 phase 1 An Adaptive, Two part, Two period, Single Sequence, Drug Interaction Study between Dolutegravir 50 mg and Prednisone in Adult Healthy Volunteers Completed
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) Completed
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. Completed
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 Completed
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 Completed
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 Completed
117175 phase 3 ING117175: a Phase IIIb, randomized, open-label study of the safety and efficacy of dolutegravir or efavirenz each administered with two NRTIs in HIV-1-infected antiretroviral therapy-naïve adults starting treatment for rifampicin-sensitive tuberculosis Active not recruiting
200304 phase 3 A Phase 3b, randomized, open-label study of the antiviral activity and safety of dolutegravir compared to lopinavir/ritonavir both administered with dual nucleoside reverse transcriptase inhibitor therapy in HIV-1 infected adult subjects with treatment failure on first line therapy Active, not recruiting
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) Completed
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) Completed
201067 phase 4 A prospective, non-interventional study of the use of dolutegravir as part of combination antiretroviral therapy in routine daily practice in Germany (DOL-ART) Active not recruiting
201102 Phase 1 A Phase 1, Open-Label, Crossover Study to Evaluate the Drug Interaction Between Dolutegravir and Daclatasvir in Healthy Adult Subjects Completed
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 Completed
201177 PRJ2203: A Prospective Observational Cohort Study to Monitor Occurrence of Hypersensitivity Reaction and Hepatotoxicity in Patients Receiving Dolutegravir Active not recruiting
201398 N/A An Exploratory Meta-Analysis of the Efficacy of Dolutegravir across Subgroups Completed
201636 phase 3 A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Rilpivirine From Current INI-, NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-Infected Adults who are Virologically Suppressed (SWORD-1) Active, not recruiting
201637 phase 3 A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Rilpivirine From Current INI-, NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-Infected Adults who are Virologically Suppressed (SWORD-2) Active not recruiting
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 Completed
201933 Drug Use Investigation for Tivicay® tablet (HRD Cooperative Investigation) Active not recruiting
202094 phase 3 An evaluation of bone mineral density in HIV-1-infected adult subjects switching from a tenofovir-containing antiretroviral therapy regimen to a dolutegravir plus rilpivirine regimen Active, not recruiting
204666 phase 4 An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and effectiveness of Tivicay administered in Korean subjects for treatment of HIV-1 infection in real life practice Recruiting
204861 phase 3 A Phase III, randomised, double blind, multicentre, Parallel group, non inferiority study evaluating the efficacy, safety, and tolerability of dolutegravir plus lamivudine compared to dolutegravir plus tenofovir/emtricitabine in human immunodeficiency virus 1 infected treatment naïve adults Active, not recruiting
204943 PRJ2568: Comparing durability, treatment failure and emergence of resistance of integrase strand transfer inhibitor treatment regimens among treatment-naïve and treatment-experienced patients with HIV Not yet recruiting
204993 Phase 1 A Phase I, relative oral bioavailability study of different fixed dose combinations of dolutegravir and lamivudine in healthy subjects Completed
204994 phase 1 An Open-label, Randomized, Single dose, Crossover, Pivotal Bioequivalence Study of Fixed-dose Combination Tablets of Dolutegravir and Lamivudine versus Dolutegravir and Lamivudine single entities and Food Effect Assessment in Healthy Volunteers Not yet recruiting
205255 phase 4 A 2-year follow-up study of a longitudinal, multicentre, historical-prospective, observational pharmacoepidemiological cohort of pretreated HIV-1-infected patients with treatment failure and initiating treatment with dolutegravir, in France Not yet recruiting
205543 phase 3 A Phase III, randomised, double-blind, multicentre, parallel-group, non-inferiority study evaluating the efficacy, safety, and tolerability of dolutegravir plus lamivudine compared to dolutegravir plus tenofovir/emtricitabine in HIV-1-infected treatment-naïve adults Active, not recruiting
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 Not yet recruiting
205846 Phase 1 PRJ2693: Descriptive Analysis of Neuropsychiatric Diagnoses in Patients taking Dolutegravir in the OPERA® Observational Database Not yet recruiting
205858 phase 3 Open-label access to dolutegravir for HIV-1 infected children and adolescents completing IMPAACT study P1093 Not yet recruiting
205893 phase 1 A 2-Part, Phase I, Single Dose, Crossover Relative Bioavailability Study of Both TIVICAY 10 mg Conventional Tablets and 5 mg Dispersible Tablets Compared to Conventional TIVICAY Tablets in Fasted Healthy Adult Subjects Not yet recruiting
206242 Prenatal Exposure to Dolutegravir and Pregnancy and Neonatal Outcomes: Data from Antiretroviral Pregnancy Registry Not yet recruiting
206254 Phase 4 Pregnancy and Neonatal Outcomes following Prenatal Exposure to Dolutegravir: Data from the European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) Completed
207445 phase 4 An open label, multi-centre, Intensive Drug Monitoring of the safety and effectiveness of Dolutegravir in China Not yet recruiting
207760 Clinical Characterization of Therapy-naïve and Therapy-experienced Patients Initiating Dolutegravir in the OPERA® Observational Database Not yet recruiting
207833 phase 4 Comparison of Dolutegravir Effectiveness vs. Other Core Agent Effectiveness among Hepatitis C Virus Co-infected patients in the OPERA® Observational Database Not yet recruiting
207953 phase 4 Dolutegravir Use and Predictors of CNS events: Meta-analysis of Data from Phase III/IIIb Clinical Trials Active not recruiting
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 Completed
ING111322 phase 1 GSK1349572 Repeat Dose Escalation Study Completed