Home > Result Summaries: Compounds > abacavir Result Summaries: abacavir GSKStudy ID Phase Title Summary (Download) 100327 Phase 4 See Detailed Description (2 citation(s)) 101093 phase 4 Pharmacogenetic Research on Hypersensitivity to Abacavir (0 citation(s)) 105736 Phase 4 An Observational, Open-Label, Multicentre, Post-Marketing Surveillance Study on the Safety and Efficacy of Abacavir in Combination with Lamivudine in HIV-1 Infected, Therapy-Naïve Adults in Germany. (0 citation(s)) 108223 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observational study to evaluate disease management and adverse events in adult subjects with HIV-1 infection who were withdrawn from CNA106030 due to a positive HLA-B*5701 test result. (0 citation(s)) 111945 N/ Studies using DAD - HIV and Hepatitis Coinfection Initiative (5 citation(s)) 111950 n\a Fractures over time stratified by HIV infection and Antiretroviral Therapy (ART) exposure (0 citation(s)) 112318 N/A Drug Use Investigation for Ziagen tablet (HRD Cooperative Investigation) (0 citation(s)) 112320 N/A Special Drug Use Investigation for Ziagen tablet (Pregnancy) (HRD Cooperative Investigation) (0 citation(s)) 112419 phase 4 Nadis retrospective data analysis (0 citation(s)) 112752 Phase 3 Zen study – Patients from the NADIS database treated with abacavir (Ziagen®), clinical and virologic data. (0 citation(s)) 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 (0 citation(s)) 112874 N/ Incidence and Risk Factors for New-onset Diabetes in HIV-infected Patients. The Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Study (1 citation(s)) 112877 Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients enrolled in the D:A:D study: a multi-cohort collaboration (0 citation(s)) 112878 N/ Diabetes Mellitus, Preexisting Coronary Heart Disease, and the Risk of Subsequent Coronary Heart Disease Events in Patients Infected With Human Immunodeficiency Virus (0 citation(s)) 112879 N/ Incidence of abacavir hypersensitivity reactions in EuroSIDA (1 citation(s)) 112884 N/ The metabolic syndrome in the DAD Study (2 citation(s)) 112885 n\a Antiretroviral Pregnancy Registry (APR)-Risk of birth defects associated with exposure to GSK HIV drugs during pregnancy (1 citation(s)) 112886 N/ Changes over time in risk factors for cardiovascular disease and use of Lipid-Lowering drugs in HIV-infected individuals and impact on myocardial infarction. (0 citation(s)) 112887 N/ Studies using DAD - Effects of different interventions to improve ART-associated dyslipidemia (1 citation(s)) 112889 N/ HIV-induced immunodeficiency and mortality from AIDS-defining and non-AIDS-defining malignancies (0 citation(s)) 113039 N/ Studies using DAD - Lipid profiles in HIV-infected patients receiving combination antiretroviral therapy: Are different antiretroviral drugs associated with different lipid profiles? (1 citation(s)) 113154 N/ Predictors of hypertension and changes of blood pressure in HIV-infected patients (2 citation(s)) 113156 N/ Studies using the VA - Studies done under the Oversight Committee for the Evaluation of the metabolic complications of HAART (2 citation(s)) 113329 n\a Lactic acid levels in children pre- and perinatally treated with antiretrovirals to prevent HIV transmission (Giaquinto; Hyperlactatemia in infants with in utero exposure to ZDV/3TC ) (0 citation(s)) 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. (0 citation(s)) CAL10001 Phase 1 An Evaluation of the Bioequivalence of a Combined Formulated Tablet (600mg/300mg abacavir/lamivudine) Compared to ZIAGEN† (abacavir) 2 X 300mg Tablets and EPIVIR† (lamivudine) 2 X 150mg Tablets Administered Concurrently and the Effect of Food on Absorption of the Combined Formulation in Healthy ... (2 citation(s)) 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. (1 citation(s)) CAL30001 phase 3 See Detailed Description (3 citation(s)) 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 (7 citation(s)) CNA10905 Phase 1 An Open-Label, Single-Arm, Pharmacokinetic Study of Abacavir and its Intracellular Anabolite Carbovir Triphosphate Following Chronic Administration of an Abacavir 300mg BID Containing Regimen (Ziagen or Trizivir) in HIV Infected Patients (2 citation(s)) CNA109586 phase 4 Study of Once-Daily Abacavir/Lamivudine versus Tenofovir/Emtricitabine, Administered with Efavirenz in Antiretroviral-Naive, HIV-1 Infected Adult Subjects (2 citation(s)) CNA109586_1 phase 4 Study of Once-Daily Abacavir/Lamivudine versus Tenofovir/Emtricitabine, Administered with Efavirenz in Antiretroviral-Naive, HIV-1 Infected Adult Subjects at 96 weeks (0 citation(s)) CNA30017 Phase 3 A Phase IIIb, Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of 2NRTI/Abacavir versus Continued 2NRTI/PI Treatment in HIV-1 Infected Subjects with Undetectable Plasma HIV-1 RNA Levels (8 citation(s)) CNA30018 Phase 3 Open-Label Trial to Evaluate the Efficacy, Safety and Tolerance of 1592U89 (Abacavir) in Paediatric Infected Patients With Encephalopathy by HIV: Virological and Immunological Markers in CSF (1 citation(s)) CNA30021 Phase 3 A Phase III, 48-week, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Abacavir (ABC) 600mg OAD vs ABC 300mg BID in Combination with Lamivudine (3TC) 300mg OAD and Efavirenz (EFV) 600mg OAD in Antiretroviral Therapy-Naïve HIV-1 Infected Subjects (7 citation(s)) CNA30024 Phase 3 A Phase III, 1:1 Randomized, Double-Blind, Controlled, Multi-center Trial Comparing the Efficacy and Safety of Abacavir Versus Zidovudine When Combined With Lamivudine and Efavirenz for Treatment of HIV-1 Infection in Antiretroviral Therapy-Naïve Adults (4 citation(s)) CNA30027 & CNA30032 Phase 4 A retrospective, case-control study to investigate genetic polymorphisms in HIV infected subjects who developed hypersensitivity following treatment with abacavir (7 citation(s)) CNA30027, CNA30032, CNA30021, CNA30024, EPV40001 Phase 4 Final report from the analysis of candidate gene markers and genome-wide single nucleotide polymorphisms(SNPs) from two retrospective, case-control studies and three controlled clinical studies to investigate geneticpolymorphisms in HIV infected subjects who developed hypersensitivity following ... (5 citation(s)) CNAA1001 Phase 1 A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of 1592U89 in HIV-Infected Children (1 citation(s)) CNAA3005 Phase 3 A Phase III Randomised, Double-Blind, Multi-center Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Nave Subjects: 48 Week Report (10 citation(s)) CNAA3006 Phase 3 A Double-Blind, Randomized, Multi-Center Trial to Evaluate the Safety and Efficacy of the Combination of 1592U89/Zidovudine (ZDV)/Lamivudine (3TC) Versus the Combination of Zidovudine (ZDV)/Lamivudine (3TC) in HIV-1 Therapy-Experienced Pediatric Patients (1 citation(s)) CNAA3007 Phase 3 1592U89 Open Label Protocol for Pediatric Patients with HIV-1 Infection (1 citation(s)) CNAA3008 Phase 3 A 1592U89 Open Label Protocol for Adult Patients with HIV-1 Infection (0 citation(s)) CNAB1006 Phase 1 A study to compare the pharmacokinetics of, and tolerability to, a single, oral, 600mg dose of 1592U89 in HIV positive subjects with and without liver disease. (0 citation(s)) CNAB2006 Phase 2 A Phase II Open-Label Observational Study of Changes in Immune Function and Lymph Node Architecture During Long-Term Suppression of Viraemia Associated With Early Combination Therapy With Abacavir and Amprenavir in Antiretroviral-Naive HIV-1 Infected Subjects With a CD4+ Cell Count ?400 cells/mm3 (3 citation(s)) CNAB3001 Phase 3 A Phase III, Randomised, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 (Abacavir) in HIV-1 Infected Patients with AIDS Dementia Complex (1 citation(s)) CNAB3002 Phase 3 A Randomised, Double-blind, Comparative, Parallel-group, Multicentre Trial to Evaluate the Safety and Efficacy of ABC Versus Placebo in Combination with Background Antiretroviral Therapy in HIV-1 Infected Antiretroviral Therapy Experienced Subjects with CD4+ cell counts ? 100 cells/mm³ and Plasm ... (3 citation(s)) CNAB3003 Phase 3 A Randomized, Double-Blind, Parallel-Group, Multicenter Trial to Evaluate the Safety and Efficacy of 1592U89 in Combination with Lamivudine (3TC) and Zidovudine (ZDV) versus 3TC/ZDV in HIV-1 Infected Antiretroviral Therapy Naive Subjects with CD4+ cell counts ?100 cells/mm³ (3 citation(s)) CNAB3004 Phase 3 An Open-Label Phase III Study to Allow Continued Access to Abacavir for HIV-Infected Adults who Have Completed a Clinical Study From the GlaxoSmithKline International Development Programme for Abacavir (CNAB3004) (0 citation(s)) CNAB3014 Phase 3 A Phase IIIb Randomised, Open-Label, Multi-centre Study to Evaluate the Safety and Efficacy of ABC/3TC/ZDV Versus IDV/3TC/ZDV in HIV-1 Infected Antiretroviral Therapy Naïve Subjects: 48 Week Report (3 citation(s)) COL30305 Phase 4 A Phase IV, Randomized, Open-Label, Multi-center, Twenty-Four-Week Pilot Study to Evaluate the Efficacy and Safety of Continued Therapy with Two Nucleoside Reverse Transcriptase Inhibitors… (1 citation(s)) COL30573 Phase 4 Substitution of Nevirapine, Efavirenz, or Abacavir for Protease Inhibitors in Patients with Human Immunodeficiency Virus Infection (3 citation(s)) COLA2012 Phase 2 A Phase II, 192-Week, Uncontrolled, Open-Label Study Designed to Evaluate the Safety and Efficacy of Novel and Highly Potent Antiretroviral Therapy (Protease Inhibitor and Nucleoside Reverse Transcriptase Inhibitor Based) in Subjects Acutely Infected with HIV-1. (GW QUAD 3) (2 citation(s)) COLA3003 Phase 2 A Phase II, 48-Week, Uncontrolled, Open-Label Study Designed to Evaluate Cellular Dynamics and Immune Restoration In Peripheral Blood and Lymphoid Tissue in Antiretroviral-Naïve, HIV-Infected Subjects Receiving a Triple-Drug Regimen Comprised of Amprenavir (600mg BID), Ritonavir (100mg BID), Aba ... (5 citation(s)) 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 (10 citation(s)) ESS40002 Phase 4 A 96-Week, Randomized, Open-Label, Multi-center Trial to Evaluate the Safety and Tolerability of the Antiretroviral Activity of Stavudine (40mg bid) + Lamivudine (150mg bid) + Nelfinavir (1250mg bid) Versus Abacavir (300mg bid) + COMBIVIR (3TC 150mg/ZDV 300mg bid) Versus COMBIVIR (3TC 150mg/ZDV ... (5 citation(s)) ESS40009 Phase 4 A Phase IV, Open-Label Study to Assess the Safety and Tolerability of Abacavir (Ziagen) in HIV-1 Infected Individuals and to Investigate the Effect of Baseline Genotype with Virtual Phenotype on the Response to Abacavir in Therapy Experienced Subjects in the Clinical Setting (6 citation(s)) ESS40010 Phase 4 ESS40010, Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL) (2 citation(s)) NZTA4008 Phase 4 A Phase IV, 48-week, Randomized, Open-label, Multicenter Trial of Abacavir (300mg BID)/Efavirenz (600mg QD)/Didanosine (400mg QD) +/- Hydroxyurea (500mg BID) in HIV-1 Infected Subjects Failing Initial Therapy with 3TC/ZDV (or d4T) +/- Protease Inhibitors (4 citation(s))
