| Titre : | Virologic and regimen termination surrogate end points in AIDS Clinical Trials. (2001) |
| Auteurs : | Peter-B Gilbert ; Victor DEGRUTTOLA ; Scott-M HAMMER ; Daniel-R KURITZKES ; Department of Biostatistics. Harvard School of Public Health. Boston. MA. USA |
| Type de document : | Article |
| Dans : | JAMA - Journal of the american medical association (vol. 285, n° 6, 2001) |
| Pagination : | 777-784 |
| Langues: | Anglais |
| Mots-clés : | Sida ; Virose ; Infection ; VIH ; Rétrovirus ; Virus ; Essai thérapeutique ; Virologie ; Effet secondaire ; Analyse coût efficacité ; Homme ; Immunopathologie ; Economie santé ; Substitution |
| Résumé : | [BDSP. Notice produite par INIST R0x9QCAQ. Diffusion soumise à autorisation]. Suppression of plasma human immunodeficiency virus (HIV) RNA levels has been widely accepted as an appropriate surrogate end point for HIV disease progression, and it is currently used as the primary end point to determine efficacy in many antiretroviral trials. However, this end point does not always measure other important effects of treatment, such as inducement of multidrug resistance, which depletes future therapy options, and toxic effects. An alternative that directly factors in these treatment costs is a composite regimen termination end point, defined as a protocol-determined change in regimen due to either virologic failure or treatment-related toxic effects. Pros and cons for using purely virologic vs various composite primary end points are discussed. Conclusions include (1) a trial's clinical objective guides the choice of primary end point, (2) a purely virologic end point is often preferable, (3) it may be important to analyze both end point types in interpreting study results, and (4) long-term clinical outcome studies are needed for identifying the most predictive surrogate end points. |
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