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 two million children who needed treatment were on it, compared with 51 per cent of adults. 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 supports 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 1,206 children with HIV aged between three 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 antiretroviral medicines; however until now there had been no research to examine whether these routine tests provided a significant benefit in children with HIV.
The study found that 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 provided only 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.
Professor Di Gibb at the MRC Clinical Trials Unit who led the trial from the UK: “Large scale clinical trials like this are important to provide conclusive evidence about practical and cost-effective ways to manage HIV-infected children. The results of ARROW show that clinically-driven monitoring of children on ART is safe and can increase treatment access at lower level health facilities near to where people live, thus ensuring that as many children receive treatment as possible.”
Professor Adeodata Kekitiinwa of the Baylor College of Medicine’s Children’s Foundation, who led one of the sites in Uganda: “The children in this trial did very well on ART. These findings should encourage healthcare workers to get children onto treatment by showing it is not too complex to manage and that monitoring weight gain is valuable. The benefits of getting children onto treatment are enormous and should take priority over spending resources on routine lab tests to monitor children on treatment which have little additional benefit.”
Professor Kusum Nathoo of the University of Zimbabwe Clinical Research Centre, who led the site in Zimbabwe: “90 per cent of children who have HIV live in sub-Saharan Africa where infrastructure, personnel and drug and laboratory supply chain problems all create barriers to rolling out HIV treatment to children. The aim of the ARROW trial was to examine whether expensive lab testing actually helped in the management of children on treatment.”
The trial was carried out by a collaboration between the 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.
A video of the trial is available to view on YouTube.
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