Markers of HIV infection in the Concorde trial

Swart, Ann Marie ORCID: https://orcid.org/0000-0002-9359-6995, Walker, A.S., Babiker, A.G., Darbyshire, J.H. and Peto, T.E.A. (1998) Markers of HIV infection in the Concorde trial. QJM, 91 (6). pp. 423-438. ISSN 1460-2725

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Abstract

The Concorde trial compared immediate (Imm) with deferred (Def) AZT monotherapy in asymptomatic HIV-positive participants. Haematological and immunological markers and weight were measured throughout, and correlated with clinical endpoints. Markers associated with disease progression (CD4 lymphocyte count and percentage, platelets, p24 antigen and ß2 microglobulin favoured Imm: those associated with toxicity (haemoglobin, neutrophils and white cell count) favoured Def. CD8 and total lymphocyte count did not differ significantly between groups. In multivariate analysis, the combination of baseline CD4, p24 antigen and ß2m was the best baseline predictor of disease. Including change in CD4 and ß2m at 12 weeks, or changes over follow-up in these markers significantly improved the fit. Markers were also incorporated into the definition of 'clinical' endpoints. Hazard ratio estimates from end-points that included CD4 <50 and CD4 <25 were closest to those for AIDS or death alone, but added very few extra events. Use of other landmark CD4 counts (100 or greater) or relative decreases in counts (25% or more) increased the number of events, but overestimated the effect of immediate AZT. Although AZT had a beneficial effect on the surrogate markers of efficacy evaluated, these changes did not predict clinical outcome, nor could the markers be usefully incorporated into an endpoint definition.

Item Type: Article
Uncontrolled Keywords: sdg 3 - good health and well-being ,/dk/atira/pure/sustainabledevelopmentgoals/good_health_and_well_being
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Groups > Norwich Clinical Trials Unit
Faculty of Medicine and Health Sciences > Research Groups > Cardiovascular and Metabolic Health
Faculty of Medicine and Health Sciences > Research Groups > Health Services and Primary Care
Faculty of Medicine and Health Sciences > Research Groups > Public Health and Health Services Research (former - to 2023)
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Depositing User: Pure Connector
Date Deposited: 24 Sep 2013 00:57
Last Modified: 01 Jun 2023 14:30
URI: https://ueaeprints.uea.ac.uk/id/eprint/43399
DOI: 10.1093/qjmed/91.6.423

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