Clinical outcomes in clinical trials of anti-HIV treatment

J Reekie; A Mocroft; Neaton J; Jens Dilling Lundgren

doi:http://dx.doi.org/10.2217/17469600.1.3.251

Clinical outcomes in clinical trials of anti-HIV treatment

J Reekie, A Mocroft, Neaton J, Jens Dilling Lundgren

Abstract

Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding and knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provide access to drugs based on short-term trials. However, no treatment has yet been found that eradicates the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?

Originalsprog	Engelsk
Tidsskrift	Future HIV Ther
Vol/bind	1
Udgave nummer	3
Sider (fra-til)	251-8
DOI	https://doi.org/10.2217/17469600.1.3.251
Status	Udgivet - 2007

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http://dx.doi.org/10.2217/17469600.1.3.251

http://www.futuremedicine.com/doi/abs/10.2217/17469600.1.3.251

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title = "Clinical outcomes in clinical trials of anti-HIV treatment",

abstract = "Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding and knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provide access to drugs based on short-term trials. However, no treatment has yet been found that eradicates the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?",

author = "J Reekie and A Mocroft and Neaton J and Lundgren, {Jens Dilling}",

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AU - Reekie, J

AU - Mocroft, A

AU - J, Neaton

AU - Lundgren, Jens Dilling

PY - 2007

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N2 - Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding and knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provide access to drugs based on short-term trials. However, no treatment has yet been found that eradicates the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?

AB - Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding and knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provide access to drugs based on short-term trials. However, no treatment has yet been found that eradicates the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?

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DO - http://dx.doi.org/10.2217/17469600.1.3.251

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SP - 251

EP - 258

JO - Future HIV Ther

JF - Future HIV Ther

IS - 3

ER -

Clinical outcomes in clinical trials of anti-HIV treatment

Abstract

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