Abacavir studies

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Study ID	Phase	Title
CNA30027, CNA30032, CNA30021, CNA30024, EPV40001	IV	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 genetic polymorphisms in HIV infected subjects who developed hypersensitivity following treatment with abacavir
ABC107442	IV	A retrospective case-control study to estimate the sensitivity and specificity of a pharmacogenetic marker (HLAB*5701) in subjects with and without hypersensitivity to abacavir.
CNA106030	IV	A phase IV, randomised, multi-centre, double-blind study to evaluate the clinical utility of prospective genetic screening (HLA-B*5701) for susceptibility to abacavir hypersensitivity.
CNA30027 & CNA30032	IV	A retrospective, case-control study to investigate genetic polymorphisms in HIV infected subjects who developed hypersensitivity following treatment with abacavir
COL30305	IV	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 (NRTIs) Plus One Protease Inhibitor (PI) Versus Switch to Two NRTIs Plus ZIAGEN (Abacavir) 300 mg BID in HIV-1 Infected Adults with HIV-1 RNA <50 copies/mL.
COL30573	IV	Substitution of Nevirapine, Efavirenz, or Abacavir for Protease Inhibitors in Patients with Human Immunodeficiency Virus Infection
ESS40002	IV	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 300mg bid) + Nelfinavir (1250mg bid) in HIV-1 Infected Subjects
ESS40003	IV	Randomized, Multicenter, Open-Label Trial to Evaluate the Reversibility of Dyslipidemia upon Substitution of Abacavir for a Protease Inhibitor in Virologically Controlled HIV (+) Subjects with Elevated Cholesterol.
ESS40009 (ZORRO)	IV	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
ESS40010	IV	ESS40010, Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL)
NZTA4008	IV	A Phase IV, 48-week, Randomized, Open-label, Multicenter Trial of Abacavir (300mg BID)/Efavirenz (600mg QD)/Didanosine (400mg QD) ą Hydroxyurea (500mg BID) in HIV-1 Infected Subjects Failing Initial Therapy with 3TC/ZDV (or d4T) ą Protease Inhibitors
WE041, WE042, WE043, WE044	IV	Frequency of Abacavir (ABC) Hypersensitivity Reactions (HSR), Rechallenge, and HSR-Attributable Outcomes are Similar with the Use of ZiagenŽ or TrizivirŽ: Final Results from the TrizivirŽ Epidemiology Study 1
WE066, EPI40007	IV	The Antiretroviral Pregnancy Registry (APR, Registry)
CNA30017	III	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
CNA30018	III	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
CNA30021	III	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-Naďve HIV-1 Infected Subjects
CNA30024	III	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-Naďve Adults
CNAA/B3007	III	1592U89 Open Label Protocol for Pediatric Patients with HIV-1 Infection
CNAA/B3008	III	A 1592U89 Open Label Protocol for Adult Patients with HIV-1 Infection
CNAA3006	III	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
CNAAB3003	III	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/mmł
CNAAB3005	III	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-Naďve Subjects: 48 Week Report
CNAB3001	III	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
CNAB3002	III	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/mmł and Plasma Viral Load Between 400 copies/mL and 50,000 copies/mL
CNAB3004	III	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)
CNAB3014	III	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 Naďve Subjects: 48 Week Report
CNAB2006	II	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 (1592U89) and Amprenavir (141W94) in Antiretroviral-Naive HIV-1 Infected Subjects With a CD4+ Cell Count =400 cells/mm3
COLA2012	II	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)
COLA3003	II	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-Naďve, HIV-Infected Subjects Receiving a Triple-Drug Regimen Comprised of Amprenavir (600mg BID), Ritonavir (100mg BID), Abacavir (300mg BID), and 3TC (150mg BID)
APV CNAB1006	I	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.
CAL10001	I	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 Adult Subjects
CAL102120	I	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.
CNA10905	I	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
CNAA1001 APV 1311001	I	A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of 1592U89 in HIV-Infected Children