Early antiretroviral therapy reduces the incidence of otorrhea in a randomized study of early and deferred antiretroviral therapy : evidence from the Children with HIV Early antiretroviral therapy (CHER) Study.
Date
2011-10
Authors
Hainline, Clotilde
Taliep, Reghana
Sorour, Gill
Nachman, Sharon
Rabie, Helena
Dobbels, Els
Janse van Rensburg, Anita
Cornell, Morna
Violari, Avy
Madhi, Shabir A.
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
Abstract Background Although otorrhea occurs commonly in HIV-infected infants, there are few data. We compared the incidence of otorrhea in infants receiving early vs deferred ART in the Children with HIV Early Antiretroviral (CHER) trial. Infants aged 6 to 12 weeks of age with confirmed HIV infection and a CD4 percentage greater than or equal to 25% were randomized to early or deferred ART at two sites in South Africa. Medical records from one study site were reviewed for otorrhea. Findings Data were reviewed from the start of the trial in July 2005 until 20 June 2007, when the Data Safety Monitoring Board recommended that randomization to the deferred arm should stop and that all infants in this arm be reviewed for commencing antiretroviral therapy. Infants entered the study at a median of 7.4 weeks of age. Eleven of 38 (29%) on deferred therapy and 7 of 75 (9%) in the early-therapy group developed otorrhea (risk ratio 3.1, 95% confidence interval (CI) 1.31-7.36; p = 0.01). Conclusions Early initiation of antiretroviral therapy is associated with significantly less otorrhea than when a deferred strategy is followed. Trial registration NCT00102960. ClinicalTrials.Gov
Description
The original publication is available at http://www.biomedcentral.com/1756-0500/4/448
Publication of this article was funded by the Stellenbosch University Open Access Fund.
Publication of this article was funded by the Stellenbosch University Open Access Fund.
Keywords
HIV-positive children -- Antiretroviral treatment -- Otitis media, HIV-positive children and deafness -- Developing countries -- Research, Hearing impaired children -- Diagnosis -- Developing countries
Citation
Hainline, C. et al 2011. Early antiretroviral therapy reduces the incidence of otorrhea in a randomized study of early and deferred antiretroviral therapy : evidence from the Children with HIV Early Antiretroviral therapy (CHER) study. BMC Research Notes. 4(1):448-151.