How is the safety of the patients on anti-HIV drugs monitored?
All participants in ARROW are monitored in the same way. They routinely visit the clinic once a month but can attend the clinic at any time if the need arises. On a scheduled visit they are seen by the counsellors and nurses, who evaluate them and may recommend them to see a doctor. Otherwise they routinely see a doctor every three months. On a routine visit, they have blood taken to monitor how well they are doing on treatment. All children have these laboratory tests carried out but half of them (selected at random) do not have their results returned to their doctors throughout the trial, i.e. the clinical examination alone is used to make health management decisions. However, for these children, doctors are able to request (and see the results of) laboratory tests if there is a concern about the health of the child. In addition all test results are reviewed and returned for the doctors attention if they are considered severe. A small group of independent experts regularly monitors t
