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Result Summaries: abacavir

ViiV
Study ID
   Phase    Title Summary (Download)
100327 Phase 4 See Detailed Description (2 citation(s)) Click here to download result summary.
101093 phase 4 Pharmacogenetic Research on Hypersensitivity to Abacavir (0 citation(s)) Click here to download result summary.
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)) Click here to download result summary.
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observational study to evaluate disease management and adverse events in adult subjects with HIV-1 infection who were withdrawn from CNA106030 due to a positive HLA-B*5701 test result.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)) Click here to download result summary.
111945 N/ Studies using DAD - HIV and Hepatitis Coinfection Initiative (5 citation(s)) Click here to download result summary.
111950 n\a Fractures over time stratified by HIV infection and Antiretroviral Therapy (ART) exposure (0 citation(s)) Click here to download result summary.
112318 N/A Drug Use Investigation for Ziagen tablet (HRD Cooperative Investigation) (1 citation(s))
112320 N/A Special Drug Use Investigation for Ziagen tablet (Pregnancy) (HRD Cooperative Investigation) (1 citation(s))
112419 phase 4 Nadis retrospective data analysis (0 citation(s)) Click here to download result summary.
112752 Phase 3 Zen study – Patients from the NADIS database treated with abacavir (Ziagen®), clinical and virologic data. (0 citation(s)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
112879 N/ Incidence of abacavir hypersensitivity reactions in EuroSIDA (1 citation(s)) Click here to download result summary.
112884 N/ The metabolic syndrome in the DAD Study (2 citation(s)) Click here to download result summary.
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)) Click here to download result summary.
112887 N/ Studies using DAD - Effects of different interventions to improve ART-associated dyslipidemia (1 citation(s)) Click here to download result summary.
112889 N/ HIV-induced immunodeficiency and mortality from AIDS-defining and non-AIDS-defining malignancies (0 citation(s)) Click here to download result summary.
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)) Click here to download result summary.
113154 N/ Predictors of hypertension and changes of blood pressure in HIV-infected patients (2 citation(s)) Click here to download result summary.
113156 N/ Studies using the VA - Studies done under the Oversight Committee for the Evaluation of the metabolic complications of HAART (2 citation(s)) Click here to download result summary.
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)) Click here to download result summary.
114382 phase 4 An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and efficacy of ZIAGEN® administered in Korean patients according to the prescribing information (0 citation(s)) Click here to download result summary.
206206 N/A Rates of Suspected Hypersensitivity Reaction to Abacavir and Associated Rates of HLA-B*5701 Testing (0 citation(s)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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 (3 citation(s)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
CNAA3007 Phase 3 1592U89 Open Label Protocol for Pediatric Patients with HIV-1 Infection (1 citation(s)) Click here to download result summary.
CNAA3008 Phase 3 A 1592U89 Open Label Protocol for Adult Patients with HIV-1 Infection (0 citation(s)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
COL30573 Phase 4 Substitution of Nevirapine, Efavirenz, or Abacavir for Protease Inhibitors in Patients with Human Immunodeficiency Virus Infection (3 citation(s)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.
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)) Click here to download result summary.