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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Findings</p> <p>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).</p> <p>Conclusions</p> <p>Early initiation of antiretroviral therapy is associated with significantly less otorrhea than when a deferred strategy is followed.</p> <p>Trial registration</p> <p><a href="http://www.clinicaltrials.gov/ct2/show/NCT00102960">NCT00102960</a>. ClinicalTrials.Gov</p

Otorrhoea is a marker for symptomatic disease in HIV-infected children

ArticleThe original publication is available at http://www.samj.org.zaBackground. Chronic otorrhoea occurs commonly in HIV-infected children. However, there are few data on incidence and severity. Objective. To document the prevalence of otorrhoea in the clinic attendees. Methods. A retrospective chart review was done of all HIV-I infected children seen at the Family Clinic for HIV from 1 February 1997 to 31 December 2001, a period preceding widespread availability of antiretrovirals: Otorrhoea was classified into two groups, viz. group 1 (mild): an episode lasting less than 1 month, and group 2 (severe): an episode lasting more than 1 month or more than 1 episode of otorrhoea. The clinical and immune stages of the children were noted. Results. Of 326 children seen during the study period, 104 (32%) had otorrhoea. Forty-five (13.8%) had mild and 59 (18.1%) severe otorrhoea. Two hundred and eighty-eight (88.6%) had either Centers for Disease Control stage B or C disease. The median CD4 percentage in children with otorrhoea was 17.5% (8.3 - 23%) versus 21% (14 - 28%) in those without otorrhoea (p=0.004). The odds ratio (OR) of children in stage B or C not having severe otorrhoea was 0.1 (0.01 - 0.72, p = 0.013). The OR for immune class 2 or 3 without severe otorrhoea was 0.39 (0.18 - 0.85, p = 0.021). Conclusions. Otorrhoea contributes to the morbidity of HIV infection in children. It is a marker for symptomatic disease and CD4 depletion and should be included in clinical classification

Effect of isoniazid prophylaxis on mortality and incidence of tuberculosis in children with HIV; randomized controlled trial.

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Effect of isoniazid prophylaxis on mortality and incidence of tuberculosis in children with HIV: randomised controlled trial

Objectives To investigate the impact of isoniazid prophylaxis on mortality and incidence of tuberculosis in children with HIV. Design Two centre prospective double blind placebo controlled trial. Participants Children aged ≥8 weeks with HIV. Interventions Isoniazid or placebo given with co-trimoxazole either daily or three times a week. Setting Two tertiary healthcare centres in South Africa. Main outcome measures Mortality, incidence of tuberculosis, and adverse events. Results Data on 263 children (median age 24.7 months) were available when the data safety monitoring board recommended discontinuing the placebo arm; 132 (50%) were taking isoniazid. Median follow-up was 5.7 (interquartile range 2.0-9.7) months. Mortality was lower in the isoniazid group than in the placebo group (11 (8%) v 21 (16%), hazard ratio 0.46, 95% confidence interval 0.22 to 0.95, P=0.015) by intention to treat analysis. The benefit applied across Centers for Disease Control clinical categories and in all ages. The reduction in mortality was similar in children on three times a week or daily isoniazid. The incidence of tuberculosis was lower in the isoniazid group (5 cases, 3.8%) than in the placebo group (13 cases, 9.9%) (hazard ratio 0.28, 0.10 to 0.78, P=0.005). All cases of tuberculosis confirmed by culture were in children in the placebo group. Conclusions Prophylaxis with isoniazid has an early survival benefit and reduces incidence of tuberculosis in children with HIV. Prophylaxis may offer an effective public health intervention to reduce mortality in such children in settings with a high prevalence of tuberculosis. Trial registration. Clinical Trials NCT0033030