DART, the largest ART clinical trial in Africa was an open randomized trial evaluating strategic approaches for the management of ART in previously untreated symptomatic HIV infected adults with CD4 cell counts <200 cells/mm3 initiating ART in Africa. A total of 3316 HIV infected symptomatic ART naïve adults took part across three centres in Uganda, and one in Zimbabwe. The main question was whether clinical monitoring only would be as safe and effective as clinical and laboratory monitoring for toxicity (haematology and biochemistry) and efficacy (CD4 counts); no virological monitoring was performed.
A second part, comparing structured treatment interruptions (STIs: 12 weeks on, 12 weeks off ART) with continuous ART in patients who achieve CD4 cell counts ≥300 cells/mm3 after 48 or 72 weeks of ART was discontinued in March 2006 following DSMC review, and all patients were switched to continuous ART. The majority of patients were started on triple NRTI: 2469 patients initiated CBV/TDF, 300 CBV/ABC and 547 CBV/NVP. Minimum follow up of each patient was be 6 years.
It demonstrated that first-line ART can be delivered safely without routine biochemistry and haematology monitoring for toxic effects.
Participants from DART form a cohort for long term follow and a resource for answering pertinent questions to issues like long term efficacy, toxicities, resistance profiles and adherence issues.
