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The evolution of clinical study design in heavily treatment-experienced persons with HIV: A critical review

The evolution of clinical study design in heavily treatment-experienced persons with HIV: A... Heavily treatment-experienced (HTE) persons with HIV have limited options for antiretroviral therapy and face many challenges, complicating their disease management. There is an ongoing need for new antiretrovirals and treatment strategies for this population. We reviewed the study designs, baseline characteristics, and results of clinical trials that enrolled HTE persons with HIV. A PubMed literature search retrieved articles published between 1995 and 2020, which were grouped by trial start date (1995–2009, N = 89; 2010–2014, N = 3; 2015–2020, N = 2). Clinical trials in HTE participants markedly declined post-2010. Participant characteristics and study designs showed changes in trends over time. As treatment strategies for HTE persons with HIV progress, we must look beyond virologic suppression to consider the broader needs of this complex heterogeneous population. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Antiviral Therapy SAGE

The evolution of clinical study design in heavily treatment-experienced persons with HIV: A critical review

17 pages

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References (135)

Publisher
SAGE
Copyright
© The Author(s) 2023
ISSN
1359-6535
eISSN
2040-2058
DOI
10.1177/13596535231174774
Publisher site
See Article on Publisher Site

Abstract

Heavily treatment-experienced (HTE) persons with HIV have limited options for antiretroviral therapy and face many challenges, complicating their disease management. There is an ongoing need for new antiretrovirals and treatment strategies for this population. We reviewed the study designs, baseline characteristics, and results of clinical trials that enrolled HTE persons with HIV. A PubMed literature search retrieved articles published between 1995 and 2020, which were grouped by trial start date (1995–2009, N = 89; 2010–2014, N = 3; 2015–2020, N = 2). Clinical trials in HTE participants markedly declined post-2010. Participant characteristics and study designs showed changes in trends over time. As treatment strategies for HTE persons with HIV progress, we must look beyond virologic suppression to consider the broader needs of this complex heterogeneous population.

Journal

Antiviral TherapySAGE

Published: May 19, 2023

Keywords: study design; virologic failure; optimized background therapy; multidrug resistance; HIV therapies

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