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

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...

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Veröffentlicht in:Antiviral Therapy 2023-06, Vol.28 (3), p.13596535231174774-13596535231174774
Hauptverfasser: Aberg, Judith A, Mills, Anthony, Moreno, Santiago, Slater, Jill, Prakash, Manyu, Clark, Andrew
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container_end_page 13596535231174774
container_issue 3
container_start_page 13596535231174774
container_title Antiviral Therapy
container_volume 28
creator Aberg, Judith A
Mills, Anthony
Moreno, Santiago
Slater, Jill
Prakash, Manyu
Clark, Andrew
description 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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source MEDLINE; Sage Journals GOLD Open Access 2024; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals
subjects Anti-HIV Agents - therapeutic use
Anti-Retroviral Agents - therapeutic use
Antiretroviral therapy
Antiviral agents
Clinical trials
HIV
HIV Infections - drug therapy
Human immunodeficiency virus
Humans
Population studies
Viral Load
title The evolution of clinical study design in heavily treatment-experienced persons with HIV: A critical review
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