How was the safety of the patients on antiretroviral drugs monitored?
All participants in DART were monitored in the same way. They routinely visited the clinic once a month but could visit the clinic more often if the need arose. On a scheduled visit they were seen by the counsellors and nurses, who evaluated them and recommend for them to see a doctor if necessary. Otherwise they routinely saw a doctor every three months. On a routine visit, they had blood taken for CD4 count analysis and other tests including tests to monitor kidney and liver function. Results were available to the clinicians for participants in the laboratory plus clinical monitoring (LCM) arm but results for participants in the clinically driven monitoring (CDM) arm were not returned to the clinicians unless they showed severe drug toxicity. A small group of independent experts regularly monitored the results of the LCM and CDM groups. Each time they recommended that the study should continue. If either group were clearly doing worse than the other, they would have recommended closi
