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 |
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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. |
doi_str_mv | 10.1177/13596535231174774 |
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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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