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

Judith A. Aberg; Anthony Mills; Santiago Moreno; Jill Slater; Manyu Prakash; Andrew Clark

doi:10.1177/13596535231174774

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

Judith A. Aberg, Anthony Mills, Santiago Moreno, Jill Slater, Manyu Prakash, Andrew Clark

Research output: Contribution to journal › Review article › peer-review

4 Scopus citations

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.

Original language	English
Journal	Antiviral Therapy
Volume	28
Issue number	3
DOIs	https://doi.org/10.1177/13596535231174774
State	Published - Jun 2023

Keywords

HIV therapies
multidrug resistance
optimized background therapy
study design
virologic failure

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

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.",

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T2 - A critical review

AU - Aberg, Judith A.

AU - Mills, Anthony

AU - Moreno, Santiago

AU - Slater, Jill

AU - Prakash, Manyu

AU - Clark, Andrew

N1 - Publisher Copyright: © The Author(s) 2023.

PY - 2023/6

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N2 - 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.

AB - 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.

KW - HIV therapies

KW - multidrug resistance

KW - optimized background therapy

KW - study design

KW - virologic failure

UR - https://www.scopus.com/pages/publications/85159755927

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

Abstract

Keywords

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