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ARROW trial shows removing routine lab testing is safe and could increase access to HIV treatments for children in Africa

07 March 2013

Results from a five year randomised control trial in Africa have shown that children on HIV treatment can be safely monitored without the need for expensive routine laboratory tests. These findings, which are published today in The Lancet, mean treatment can be given much more cheaply, which may help more children get access to life-saving treatment.

This short film gives an overview of the ARROW findings about how to monitor children on ART.

Access to antiretroviral treatments (ART) for children in Africa is significantly lagging behind that of adults – by the end of 2011 only 28 per cent of the 2 million children who needed treatment were on it, compared with 51 per cent of adults in need. Furthermore, more than half of HIV-infected infants and young children die before their second birthday.

The ARROW trial was set up in Uganda and Zimbabwe to assess whether replacing expensive routine lab tests to monitor ART with careful clinical care and follow-up could be safely implemented. By conclusively showing that this can be done, this trial greatly adds to the argument that resources are best spent extending access to life-saving treatment, rather than doing routine lab tests which add little benefit.

The ARROW trial studied 1206 children with HIV aged between 3 months and 17 years in Uganda and Zimbabwe over a period of five years. Routine laboratory tests have historically been administered every three to six months to assess the severity of the virus, the strength of the immune system and side effects of the ARV medicines; however until now there had been no research to examine whether these routine tests provided a significant benefit in children with HIV.

Adding routine laboratory tests had no effect on the number of children reporting side-effects from ART treatment and measuring the strength of the immune system by monitoring CD4 levels only provided a small clinical benefit, which occurred later and mainly in older children. The study also showed that once children start to receive HIV treatment they respond extremely well. Few children in the trial died (25 in the clinical group and 29 in the lab monitoring group), most developed good immune systems, and few needed to change medicines. Children who were monitored clinically were just as likely to have undetectable virus levels in the blood throughout the trial as those who received routine lab tests.

The trial was carried out by a collaboration of  MRC Clinical Trials Unit in London; Joint Clinical Research Centre, MRC/UVRI Uganda Research Unit on AIDS and Baylor College of Medicine Children’s Foundation in Uganda; and University of Zimbabwe Clinical Research Centre in Zimbabwe. Drugs were donated by ViiV Healthcare and GlaxoSmithKline.