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Protocol Summaries: abacavir

ViiV
Study ID
   Phase    Title Status
100327 Phase 4 See Detailed Description Completed
109477 phase 4 Prospective epidemiological study of the prevalence of HLAB*5701 in HIV-1 infected patients Completed
111950 n\a Fractures over time stratified by HIV infection and Antiretroviral Therapy (ART) exposure Completed
112872 n\a HIV treatment and CVD events - Ingenix. Retrospective Database Analysis of Patients with Human Immunodeficiency Virus (HIV) Treatment and Cardiovascular Disease (CVD) Events Completed
112885 n\a Antiretroviral Pregnancy Registry (APR)-Risk of birth defects associated with exposure to GSK HIV drugs during pregnancy Recruiting
114382 phase 4 An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and efficacy of ZIAGENĀ® administered in Korean patients according to the prescribing information Completed
206206 N/A Rates of Suspected Hypersensitivity Reaction to Abacavir and Associated Rates of HLA-B*5701 Testing Not yet recruiting
206247 phase 4 Post-marketing safety analyses for multiple marketed products in collaboration with the D:A:D study Not yet recruiting
206307 phase 4 Abacavir Usage Patterns and Trends in Hypersensitivity Reactions (HSR) in the EuroSIDA cohort Not yet recruiting
207263 phase 4 Abacavir Use and Risk for Myocardial Infarction and Coronary Artery Disease: Meta-analysis of Data from Clinical Trials Active not recruiting
207831 phase 4 Rates of Suspected Hypersensitivity Reaction in HIV infected Adult treatment populations screened HLA-B*5701 negative prior to commencing Abacavir therapy: Meta-analysis of Data from GlaxoSmithKline and ViiV Healthcare Sponsored Clinical Trials Not yet recruiting
ABC107442 Phase 4 A retrospective case-control study to estimate the sensitivity and specificity of a pharmacogenetic marker (HLA-B*5701) in subjects with and without hypersensitivity to abacavir. Completed
CAL102120 phase 1 An open-label, two-period, crossover, pharmacokinetic study of abacavir and its intracellular anabolite carbovir triphosphate following once-daily and twice-daily administration of abacavir in HIV-infected subjects. Completed
CAL30001 phase 3 A phase III, randomized, open-label, parallel, multicenter study to evaluate treatment with fixed-dose combination of abacavir/lamivudine (600mg/300mg) once-daily versus abacavir (300mg) twice-daily and lamivudine (300mg) once-daily in combination with tenofovir once-daily and a new PI or NNRTI for 48 weeks in ART-experienced HIV-1 infected patients Completed
CNA106030 Phase 4 A phase IV, randomised, multicentre, double-blind, study to evaluate the clinical utility of prospective genetic screening (HLA-B*5701) for susceptibility to abacavir hypersensitivity Completed
CNA108223 Phase 4 A retrospective, multi-centre observational study to evaluate disease management and adverse events in adult subjects with HIV-1 infection who were withdrawn from CNA106030 due to a positive HLA-B*5701 test result Completed
CNA109479 phase 4 Prospective epidemiological study of the prevalence of HLA-B*5701 in HIV-1 infected UK patients Completed
CNA109586 phase 4 Study of Once-Daily Abacavir/Lamivudine versus Tenofovir/Emtricitabine, Administered with Efavirenz in Antiretroviral-Naive, HIV-1 Infected Adult Subjects Completed
CNA110329 Phase 4 Prospective epidemiological study of the prevalence of HLA-B*5701 in HIV-1 infected patients Completed
EPZ104057 Phase 4 A 96-Week, Phase IV, Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of EPZICOM Versus TRUVADA Administered in Combination with KALETRA in Antiretroviral-Naive HIV-1 Infected Subjects Completed