The DOI matches its Crossref record; 38 of the 38 references it cites were found in a registry or an index.
Abacavir-Lamivudine-Zidovudine vs Indinavir-Lamivudine-Zidovudine in Antiretroviral-Naive HIV-Infected Adults<SUBTITLE>A Randomized Equivalence Trial</SUBTITLE>
Abstract
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 o…
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“In the former, the interest is in the difference between proportions.This is called the absolute risk difference (ARD) and is the measure used in the abacavir-indinavir trial 1 .”
From Understanding Equivalence and Noninferiority Testing (2011) · cites this paper as [1]
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Cites
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Empirical evidence of design-related bias in studies of diagnostic tests.
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Gazzard, B., & on behalf of the BHIVA Treatment Guidelines Writing Group (2008) · HIV Medicine · doi:10.1111/j.1468-1293.2008.00636.x · Cited by 1,090
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Antiretroviral Therapy in Adults
Carpenter, C. C. J., Cooper, D. A., Fischl, M. A., Gatell, J. M., Gazzard, B., Hammer, S. M., Hirsch, M., Jacobsen, D. M., Katzenstein, D. A., Montaner, J. S. G., et al. (2000) · JAMA · doi:10.1001/jama.283.3.381 · Cited by 1,007
Staszewski, S., Morales-Ramirez, J. O., Tashima, K. T., Rachlis, A., Skiest, D. J., Stanford, J., Stryker, R., Johnson, P. C., Labriola, D., Farina, D., et al. (1999) · New England Journal of Medicine · doi:10.1056/nejm199912163412501 · Cited by 993
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Piaggio, G., Elbourne, D. R., Pocock, S. J., Evans, S. J. W., Altman, D. G., & CONSORT Group, F. T. (2012) · JAMA · doi:10.1001/jama.2012.87802 · Cited by 2,428
HLA-B*5701 Screening for Hypersensitivity to Abacavir
Mallal, S. A., Phillips, E. J., Carosi, G., Molina, J., Workman, C., Tomažič, J., Jägel-Guedes, E., Rugină, S., Козырев, О. А., Cid, J. F., et al. (2008) · New England Journal of Medicine · doi:10.1056/nejmoa0706135 · Cited by 1,834
Gazzard, B., & on behalf of the BHIVA Treatment Guidelines Writing Group (2008) · HIV Medicine · doi:10.1111/j.1468-1293.2008.00636.x · Cited by 1,090
Treatment for Adult HIV Infection
Hammer, S. M., Saag, M. S., Schechter, M., Montaner, J. S. G., Schooley, R. T., Jacobsen, D. M., Thompson, M., Carpenter, C. C. J., Fischl, M. A., Gazzard, B., et al. (2006) · JAMA · doi:10.1001/jama.296.7.827 · Cited by 1,034
Treatment for Adult HIV Infection
Yéni, P., Hammer, S. M., Hirsch, M., Saag, M. S., Schechter, M., Carpenter, C. C. J., Fischl, M. A., Gatell, J. M., Gazzard, B., Jacobsen, D. M., et al. (2004) · JAMA · doi:10.1001/jama.292.2.251 · Cited by 780
Metadata
- Authors
- Staszewski, S.
- Affiliations
- Goethe University Frankfurt (DE)
- Corresponding author
- Staszewski, Schlomo
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2001-03-07
- Volume
- 285
- Issue
- 9
- Pages
- 1155
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2129710521
- Cited by
- 277
- References
- 38
- Citations by year
- 2026: 1 · 2023: 1 · 2022: 2 · 2020: 2 · 2019: 2 · 2018: 2 · 2017: 2 · 2016: 5 · 2015: 5 · 2014: 5 · 2013: 10 · 2012: 6
- FWCI
- 31.43
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Life Sciences › Immunology and Microbiology › Virology › HIV Research and Treatment
- Keywords
- abacavir, indinavir, lamivudine, zidovudine, HIV infection, antiretroviral-naive patients, triple-drug combination therapy, nucleoside reverse transcriptase inhibitors, protease inhibitors, viral suppression, treatment safety, drug interactions, adverse events, CD4 count, HIV RNA
- MeSH terms
- Abacavir, Adult, Aged, Double-Blind Method, Drug Resistance, Microbial, Female, Genotype, HIV, Humans, Male, Middle Aged, Mutation, Therapeutic Equivalency, Zidovudine, Dideoxynucleosides, HIV Infections, Survival Analysis, HIV Protease Inhibitors, CD4 Lymphocyte Count, Reverse Transcriptase Inhibitors, Lamivudine, Anti-HIV Agents, Indinavir, Viral Load, Antiretroviral Therapy, Highly Active, HIV Reverse Transcriptase
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