Online citations, reference lists, and bibliographies.
← Back to Search

Abacavir-lamivudine-zidovudine Vs Indinavir-lamivudine-zidovudine In Antiretroviral-naive HIV-infected Adults: A Randomized Equivalence Trial.

S. Staszewski, P. Keiser, J. Montaner, F. Raffi, J. Gathe, V. Brotas, C. Hicks, S. Hammer, D. Cooper, M. Johnson, S. M. Tortell, A. Cutrell, D. Thorborn, R. Isaacs, S. Hetherington, H. Steel, W. Spreen
Published 2001 · Medicine

Save to my Library
Download PDF
Analyze on Scholarcy Visualize in Litmaps
Share
Reduce the time it takes to create your bibliography by a factor of 10 by using the world’s favourite reference manager
Time to take this seriously.
Get Citationsy
CONTEXT Abacavir, a nucleoside analogue, has demonstrated suppression of human immunodeficiency virus (HIV) replication alone and in combination therapy. However, the role of abacavir in a triple nucleoside combination regimen has not been evaluated against a standard protease inhibitor-containing regimen for initial antiretroviral treatment. OBJECTIVE To evaluate antiretroviral equivalence and safety of an abacavir-lamivudine-zidovudine regimen compared with an indinavir-lamivudine-zidovudine regimen. DESIGN AND SETTING A multicenter, phase 3, randomized, double-blind trial with an enrollment period from August 1997 to June 1998, with follow-up through 48 weeks at 73 clinical research units in the United States, Canada, Australia, and Europe. PATIENTS Five hundred sixty-two antiretroviral-naive, HIV-infected adults with a plasma HIV RNA level of at least 10 000 copies/mL and a CD4 cell count of at least 100 x 10(6)/L. INTERVENTIONS Patients were stratified by baseline HIV RNA level and randomly assigned to receive a combination tablet containing 150 mg of lamivudine and 300 mg of zidovudine twice daily plus either 300 mg of abacavir twice daily and indinavir placebo or 800 mg of indinavir every 8 hours daily plus abacavir placebo. After 16 weeks, patients with confirmed HIV RNA levels greater than 400 copies/mL were eligible to continue receiving randomized treatment or receive open-label therapy. MAIN OUTCOME MEASURE Virologic suppression, defined as HIV RNA concentration of 400 copies/mL or less at week 48. RESULTS The proportion of patients who met the end point of having an HIV RNA level of 400 copies/mL or less at week 48 was equivalent in the abacavir group (51% [133/262]) and in the indinavir group (51% [136/265]) with a treatment difference of -0.6% (95% confidence interval [CI], -9% to 8%). In patients with baseline HIV RNA levels greater than 100 000 copies/mL, the proportion of patients achieving less than 50 copies/mL was greater in the indinavir group than in the abacavir group with 45% (45/100) vs 31% (30/96) and a treatment diference of -14% (95% CI, -27% to 0%). The 2 treatments were comparable with respect to their effects on CD4 cell count. There was no difference between groups in the frequency of treatment-limiting adverse events or laboratory abnormalities. One death in the abacavir group was attributed to hypersensitivity reaction, which occurred following rechallenge with abacavir, approximately 3 weeks after initiating study treatment. CONCLUSIONS In this study of antiretroviral-naive HIV-infected adults, the triple nucleoside regimen of abacavir-lamivudine-zidovudine was equivalent to the regimen of indinavir-lamivudine-zidovudine in achieving a plasma HIV RNA level of less than 400 copies/mL at 48 weeks.
This paper references
10.32388/1n0td5
Clinic
F. H. Houghton (1907)
10.1093/CLINIDS/17.4.802
1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults.
K. Castro (1992)
10.1038/365671A0
Quantitative detection of HIV-1 drug resistance mutations by automated DNA sequencing
B. Larder (1993)
10.7326/0003-4819-120-8-199404150-00008
Guidelines for Meta-analyses Evaluating Diagnostic Tests
L. Irwig (1994)
10.1016/0197-2456(94)90036-1
The case for confidence intervals in controlled clinical trials.
M. Borenstein (1994)
10.1128/AAC.41.5.1099
Unique intracellular activation of the potent anti-human immunodeficiency virus agent 1592U89.
M. Faletto (1997)
10.1056/NEJM199709113371102
Treatment with indinavir, zidovudine, and lamivudine in adults with human immunodeficiency virus infection and prior antiretroviral therapy.
R. Gulick (1997)
10.1128/AAC.41.5.1094
Combination of mutations in human immunodeficiency virus type 1 reverse transcriptase required for resistance to the carbocyclic nucleoside 1592U89
M. Tisdale (1997)
10.1097/00002030-199714000-00002
Potential factors affecting adherence with HIV therapy
S. Mehta (1997)
10.1056/NEJM199709113371101
A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. AIDS Clinical Trials Group 320 Study Team.
S. Hammer (1997)
Unique intracellular activation of the potent anti-HIV agent 1592U89
MB Faletto (1997)
Unique intracellular activation of the potent anti-HIV agent 1592U89
MB Faletto (1997)
10.1097/00002030-199813000-00008
Suppression of plasma viral load below 20 copies/ml is required to achieve a long‐term response to therapy
Janet M. Raboud (1998)
10.1097/00002030-199816000-00002
Antiretroviral effect and safety of abacavir alone and in combination with zidovudine in HIV‐infected adults
Michael S. Saag (1998)
10.1001/JAMA.280.1.35
Simultaneous vs sequential initiation of therapy with indinavir, zidovudine, and lamivudine for HIV-1 infection: 100-week follow-up.
R. Gulick (1998)
10.1016/S0140-6736(98)03391-1
Pathogenesis of HIV-1-protease inhibitor-associated peripheral lipodystrophy, hyperlipidaemia, and insulin resistance
A. Carr (1998)
10.1097/00002030-199805000-00001
The duration of viral suppression during protease inhibitor therapy for HIV‐1 infection is predicted by plasma HIV‐1 RNA at the nadir
D. Kempf (1998)
10.1097/00002030-199811000-00005
Predictors of long‐term response to protease inhibitor therapy in a cohort of HIV‐infected patients
J. Casado (1998)
10.1097/00002030-199816000-00001
A dose‐ranging study to evaluate the safety and efficacy of abacavir alone or in combination with zidovudine and lamivudine in antiretroviral treatment‐naive subjects
S. Staszewski (1998)
10.1097/00002030-199807000-00003
A syndrome of peripheral lipodystrophy, hyperlipidaemia and insulin resistance in patients receiving HIV protease inhibitors
A. Carr (1998)
10.1016/S0140-6736(98)03202-4
6-year experience of prenatal diagnosis in an unselected population in Oxford, UK
P. Boyd (1998)
10.1097/00019048-200103000-00027
Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents. Department of Health and Human Services and Henry J. Kaiser Family Foundation.
Henry J. Kaiser (1998)
10.1136/bmj.305.6860.1017
Antenatal screening for Down's syndrome.
H. Cuckle (1998)
Eudra Web site . Points to consider on switching between superiority and non - inferiority
M Borenstein (1998)
dictors of long - term response to protease inhibitor therapy in a cohort of HIV - infected patients
SG Deeks (1998)
A doseranging study to evaluate the safety and efficacy of abacavir alone or in combination with zidovudine and lamivudine in antiretroviral treatment-naive subjects. AIDS
S Staszewski (1998)
Genotypic and phenotypic correlates of response to abacavir (ABC, 1592)
R Lanier (1998)
Discontinuation (D/C) of protease inhibitor (PI) therapy: reasons and risk factors
VE Stone (1998)
Discontinuation (D/C) of protease inhibitor (PI) therapy: reasons and risk factors
VE Stone (1998)
10.1097/00002030-199904160-00001
HIV RNA and CD4 cell count response to protease inhibitor therapy in an urban AIDS clinic: response to both initial and salvage therapy.
S. Deeks (1999)
10.1001/JAMA.282.11.1061
Empirical evidence of design-related bias in studies of diagnostic tests.
J. Lijmer (1999)
10.1056/NEJM199912163412501
Efavirenz plus zidovudine and lamivudine, efavirenz plus indinavir, and indinavir plus zidovudine and lamivudine in the treatment of HIV-1 infection in adults. Study 006 Team.
S. Staszewski (1999)
10.1016/S0140-6736(99)01122-8
Clinical progression and virological failure on highly active antiretroviral therapy in HIV-1 patients: a prospective cohort study
B. Ledergerber (1999)
10.1086/314998
Suppression of plasma virus load below the detection limit of a human immunodeficiency virus kit is associated with longer virologic response than suppression below the limit of quantitation.
J. Raboud (1999)
Ziagen (Abacavir, ABC, 1592) combined with 3TC & ZDV is highly effective and durable through 48 weeks in HIV-1 infected antiretroviral-naı̈ve subjects (CNAB3003)
M Fischl (1999)
The Atlantic study: a randomized, open-label trial comparing two protease inhibitor (PI)-sparing antiretroviral strategies versus a standard PI-containing regimen, 48 week data
RL Murphy (1999)
10.1001/JAMA.283.2.229
Drug susceptibility in HIV infection after viral rebound in patients receiving indinavir-containing regimens.
D. Havlir (2000)
10.1097/00002030-200007280-00015
A comparison of stavudine plus lamivudine versus zidovudine plus lamivudine in combination with indinavir in antiretroviral naive individuals with HIV infection: selection of thymidine analog regimen therapy (START I)
K. Squires (2000)
10.1097/00002030-200006160-00017
Absence of zidovudine resistance in antiretroviral-naive patients following zidovudine/lamivudine/protease inhibitor combination therapy: virological evaluation of the AVANTI 2 and AVANTI 3 studies
M. Maguire (2000)
10.1046/j.1469-0705.2000.00071.x
Combined ultrasound biometry, serum markers and age for Down syndrome risk estimation
R. Bahado-singh (2000)
10.1177/135965350000500306
Amprenavir in Combination with Lamivudine and Zidovudine versus Lamivudine and Zidovudine Alone in HIV-1-Infected Antiretroviral-Naive Adults
Jeffery C Goodgame (2000)
10.1016/S0140-6736(00)02388-6
Hit HIV-1 hard, but only when necessary
M. Harrington (2000)
10.1097/00002030-200001280-00012
HIV-1 reverse transcriptase (RT) genotype and susceptibility to RT inhibitors during abacavir monotherapy and combination therapy
V. Miller (2000)
10.1310/4R1B-8F60-B57H-0ECN
Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents, January 28, 2000
A. Fauci (2000)
10.1097/00001432-200002000-00004
Considerations in the choice of protease inhibitor-sparing regimens in initial therapy for HIV-1 infection.
G. Moyle (2000)
10.1001/JAMA.283.2.205
Mechanisms of virologic failure in previously untreated HIV-infected patients from a trial of induction-maintenance therapy. Trilège (Agence Nationale de Recherches sur le SIDA 072) Study Team).
D. Descamps (2000)
10.1086/315317
Resistance profile of the human immunodeficiency virus type 1 reverse transcriptase inhibitor abacavir (1592U89) after monotherapy and combination therapy. CNA2001 Investigative Group.
P. Harrigan (2000)
10.1001/JAMA.283.3.381
Antiretroviral therapy in adults: updated recommendations of the International AIDS Society-USA Panel.
C. Carpenter (2000)
10.5691/JJB.27.S96
Points to consider on switching between superiority and non-inferiority.
H. Nishiyama (2001)
10.1111/j.1468-1293.2005.0311b.x
British HIV Association (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy.
Bg Gazzard and (2001)
10.1016/S0149-2918(01)80132-6
Hypersensitivity reactions during therapy with the nucleoside reverse transcriptase inhibitor abacavir.
S. Hetherington (2001)
continuation ( D / C ) of protease inhibitor ( PI ) therapy : reasons and risk factors
MB Faletto



This paper is referenced by
10.1097/FPC.0000000000000409
Abacavir adverse reactions related with HLA-B*57:01 haplotype in a large cohort of patients infected with HIV
E. Quiros-Roldan (2020)
10.1002/cpt.1944
Global Frequencies of Clinically Important HLA Alleles and Their Implications For the Cost‐Effectiveness of Preemptive Pharmacogenetic Testing
Yitian Zhou (2020)
10.4093/dmj.2019.0099
γ-Linolenic Acid versus α-Lipoic Acid for Treating Painful Diabetic Neuropathy in Adults: A 12-Week, Double-Placebo, Randomized, Noninferiority Trial
J. Won (2019)
Recomendaciones de GESIDA/Plan Nacional sobre el Sida respecto al tratamiento antirretroviral en adultos infectados por el virus de la inmunodeficiencia humana (actualización enero de 2007)
Documento de Consenso (2019)
10.1002/9783527812103.CH3
Enzymatic Synthesis of Nucleic Acid Derivatives Using Whole Cells
E. Lewkowicz (2018)
10.1097/QAI.0000000000001660
Twenty-Five Years of Lamivudine: Current and Future Use for the Treatment of HIV-1 Infection
R. Quercia (2018)
10.1038/tpj.2016.34
Assessment of pharmacogenetic tests: presenting measures of clinical validity and potential population impact in association studies
E. C. Tonk (2017)
10.18578/bnf.107868576
Abacavir / Lamivudine /
H. Sprenger (2017)
10.22237/JMASM/1493596920
An Empirical Demonstration of the Need for Exact Tests
V. Berger (2017)
Changes in immunological, biochemical and hematological parameters of HIV-1 positive patients on antiretroviral therapy in Mbagathi County Hospital, Nairobi
Emelda Gekondo Nyairo (2017)
10.3947/ic.2017.49.3.205
Safety and Efficacy of Ziagen (Abacavir Sulfate) in HIV-Infected Korean Patients
Heawon Ann (2017)
10.1016/S2352-3018(16)30091-1
Comparative efficacy and safety of first-line antiretroviral therapy for the treatment of HIV infection: a systematic review and network meta-analysis.
S. Kanters (2016)
10.1016/B978-0-12-802220-7.00010-7
Pharmacogenomics in Drug Discovery, Prospects and Clinical Applicability
Odilia Osakwe (2016)
10.1111/tmi.12694
Evaluating facility‐based antiretroviral therapy programme effectiveness: a pilot study comparing viral load suppression and retention rates
H. Duber (2016)
10.1517/13543784.2015.1052403
Development of experimental and early investigational drugs for the treatment of Ebola virus infections
G. Wong (2015)
10.1128/CMR.00014-15
Backs against the Wall: Novel and Existing Strategies Used during the 2014-2015 Ebola Virus Outbreak
G. Wong (2015)
A randomized , controlled trial of initial anti-retroviral therapy with abacavir / lamivudine / zidovudine twice-daily compared to atazanavir once-daily with lamivudine / zidovudine twice-daily in HIV-infected patients over 48 weeks ( ESS 100327 , the ACTION Study )
Princy N. Kumar (2015)
Abacavir: una revisión actualizada sobre sus propiedades y aplicaciones
C. Martínez (2015)
10.1007/s12010-015-1565-7
Enantioselective Resolution of γ-Lactam by a Novel Thermostable Type II (+)-γ-Lactamase from the Hyperthermophilic Archaeon Aeropyrum pernix
L. Ren (2015)
Recomendations from GESIDA/National AIDS plan on antiretroviral therapy in adult patients infected by the human immunodeficiency virus (October 2004)
J. Iribarren (2015)
Estimation of the size and characteristics of HIV-positive populations in Europe
F. Nakagawa (2015)
10.1016/B978-0-7020-6285-8.00152-0
Drugs for HIV infection.
Benjamin Eckhardt (2014)
10.1016/B978-0-12-386882-4.00021-9
HLA and the Pharmacogenomics of Drug Hypersensitivity
K. White (2014)
10.1093/jac/dku279
Virological efficacy of abacavir: systematic review and meta-analysis.
M. Cruciani (2014)
10.1128/AAC.03469-14
Population Pharmacokinetics of Abacavir in Pregnant Women
F. Fauchet (2014)
10.1097/INF.0000000000000222
Virologic Response in Children Treated With Abacavir-compared With Stavudine-based Antiretroviral Treatment: A South African Multi-Cohort Analysis
Karl-Günter Technau (2014)
10.1002/pds.3589
Safety analysis of Ziagen® (abacavir sulfate) in postmarketing surveillance in Japan†
T. Kurita (2014)
10.3851/IMP2726
A Systematic Review of a Single-Class Maintenance Strategy with Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Hiv/Aids
H. Sprenger (2014)
10.1002/14651858.CD005481.pub3
Co-formulated abacavir-lamivudine-zidovudine for initial treatment of HIV infection and AIDS.
M. Shey (2013)
10.1186/1742-4690-10-82
Evolving uses of oral reverse transcriptase inhibitors in the HIV-1 epidemic: from treatment to prevention
R. Gupta (2013)
10.1371/journal.pone.0055111
Effectiveness of Efavirenz-Based Regimens in Young HIV-Infected Children Treated for Tuberculosis: A Treatment Option for Resource-Limited Settings
J. V. van Dijk (2013)
10.1097/INF.0b013e31828e8c09
Use of Nucleoside Reverse Transcriptase Inhibitor–only Regimens in HIV-infected Children and Adolescents
M. Neely (2013)
See more
Semantic Scholar Logo Some data provided by SemanticScholar