Horizon / Plein textes La base de ressources documentaires de l'IRD

IRD

Publications des scientifiques de l'IRD

Ford D., Turner R., Turkova A., Penazzato M., Musiime V., Bwakura-Dangarembizi M., Violari A., Chabala C., Puthanakit T., Sudjaritruk T., Cressey T. R., Lallemant Marc, Gibb D. M. (2018). Optimizing clinical trial design to maximize evidence generation in pediatric HIV. JAIDS. Journal of Acquired Immune Deficiency Syndromes, 78 (1), S40-S48. ISSN 1525-4135

Fichier PDF disponible http://horizon.documentation.ird.fr/exl-doc/pleins_textes/divers18-09/010073775.pdf

Lien direct chez l'éditeur doi:10.1097/qai.0000000000001748

Titre
Optimizing clinical trial design to maximize evidence generation in pediatric HIV
Année de publication2018
Type de documentArticle référencé dans le Web of Science WOS:000440567700008
AuteursFord D., Turner R., Turkova A., Penazzato M., Musiime V., Bwakura-Dangarembizi M., Violari A., Chabala C., Puthanakit T., Sudjaritruk T., Cressey T. R., Lallemant Marc, Gibb D. M.
SourceJAIDS. Journal of Acquired Immune Deficiency Syndromes, 2018, 78 (1), p. S40-S48. ISSN 1525-4135
RésuméFor HIV-infected children, formulation development, pharmacokinetic (PK) data, and evaluation of early toxicity are critical for licensing new antiretroviral drugs; direct evidence of efficacy in children may not be needed if acceptable safety and PK parameters are demonstrated in children. However, it is important to address questions where adult trial data cannot be extrapolated to children. In this fast-moving area, interventions need to be tailored to resource-limited settings where most HIV-infected children live and take account of decreasing numbers of younger HIV-infected children after successful prevention of mother-to-child HIV transmission. Innovative randomized controlled trial (RCT) designs enable several questions relevant to children's treatment and care to be answered within the same study. We reflect on key considerations, and, with examples, discuss the relative merits of different RCT designs for addressing multiple scientific questions including parallel multi-arm RCTs, factorial RCTs, and crossover RCTs. We discuss inclusion of several populations (eg, untreated and pretreated children; children and adults) in "basket" trials; incorporation of secondary randomizations after enrollment and use of nested substudies (particularly PK and formulation acceptability) within large RCTs. We review the literature on trial designs across other disease areas in pediatrics and rare diseases and discuss their relevance for addressing questions relevant to HIV-infected children; we provide an example of a Bayesian trial design in prevention of mother-to-child HIV transmission and consider this approach for future pediatric trials. Finally, we discuss the relevance of these approaches to other areas, in particular, childhood tuberculosis and hepatitis.
Plan de classementEntomologie médicale / Parasitologie / Virologie [052] ; Santé : généralités [050]
LocalisationFonds IRD [F B010073775]
Identifiant IRDfdi:010073775
Lien permanenthttp://www.documentation.ird.fr/hor/fdi:010073775

Export des données

Disponibilité des documents

Télechargment fichier PDF téléchargeable

Lien sur le Web lien chez l'éditeur

Accès réservé en accès réservé

HAL en libre accès sur HAL


Accès aux documents originaux :

Le FDI est labellisé CollEx

Accès direct

Bureau du chercheur

Site de la documentation

Espace intranet IST (accès réservé)

Suivi des publications IRD (accès réservé)

Mentions légales

Services Horizon

Poser une question

Consulter l'aide en ligne

Déposer une publication (accès réservé)

S'abonner au flux RSS

Voir les tableaux chronologiques et thématiques

Centres de documentation

Bondy

Montpellier (centre IRD)

Montpellier (MSE)

Cayenne

Nouméa

Papeete

Abidjan

Dakar

Niamey

Ouagadougou

Tunis

La Paz

Quito