Abstract
Single-arm clinical trials are useful to evaluate antiretroviral regimens in certain populations of HIV-infected treatment-naive patients for whom a randomized controlled trial is not feasible or desirable. They can also be useful to establish initial estimates of efficacy and safety/tolerability of novel regimens to inform the design of large phase III trials. In this article, we discuss key design considerations for such single-arm studies.
Publication types
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Research Support, N.I.H., Extramural
MeSH terms
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Antiretroviral Therapy, Highly Active / methods*
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Clinical Trials, Phase III as Topic / methods*
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Clinical Trials, Phase III as Topic / statistics & numerical data
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Confidence Intervals
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HIV Infections / drug therapy*
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HIV Infections / virology
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HIV-1
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Humans
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RNA, Viral / blood
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Randomized Controlled Trials as Topic / methods*
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Randomized Controlled Trials as Topic / statistics & numerical data
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Treatment Failure
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Treatment Outcome