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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

Clotilde Hainline12, Reghana Taliep3, Gill Sorour3, Sharon Nachman2, Helena Rabie3, Els Dobbels3, Anita Janse van Rensburg3, Morna Cornell4, Avy Violari5, Shabir A Madhi6 and Mark F Cotton3*

Author Affiliations

1 School of Medicine, Stony Brook University, Stony Brook, New York, USA

2 Division of Infectious Diseases, Stony Brook University, Stony Brook, New York, USA

3 Department of Paediatrics and Child Health and Children's Infectious Diseases Clinical Research Unit (KID-CRU), Tygerberg Children's Hospital and Faculty of Health Sciences, Stellenbosch University, Tygerberg, South Africa

4 School of Public Health, University of Cape Town, South Africa

5 Perinatal HIV Research Unit, University of Witwatersrand, South Africa

6 Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, South Africa

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BMC Research Notes 2011, 4:448  doi:10.1186/1756-0500-4-448

Published: 26 October 2011

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

    C
hildren with
    H
IV
    E
arly Anti
    r
etroviral (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