Subsequent to enrolment in the trial, ART was provided to eligible study participants through routine government services for management of their HIV infection.
During the treatment phase of the trial, art therapists and activity group facilitators received local monthly group supervision.
During the treatment phase of the trial, art therapists and activity group facilitators received monthly group supervision from a senior practitioner with relevant expertise.
Table 3 summarizes the design and main findings of most of the randomized controlled trials of ART modification in virologically suppressed patients.
Currently, there is considerable interest and ongoing trials in ART simplification strategies [19], such as using a single boosted protease inhibitor as a maintenance regimen in those who are stable and virologically suppressed on ART [20], which will also reduce the cost of lifelong ART.
Global functioning had not been assessed in randomised trials of Art Therapy for people with schizophrenia that had been completed when the study was being planned, so data on mean GAF scores and standard deviations were taken from previous trials of Compliance Therapy and Cognitive Therapy for people with schizophrenia.
In a previous report [ 6], we described the implementation of a general method, Assessment of Resources for Trials or ART, for designing a trial allowing for possible non-uniform accrual rates, non-proportional hazards, loss to follow-up and cross-over of patients between treatment arms.
As new ARVs with improved toxicity profiles have been developed, there have been an increasing number of clinical trials of ART modification in virologically suppressed patients, and many of these studies have been summarized in an excellent review by Van den Eynde and Podzamczer [ 11].
The ANRS 116 trial was a prospective, open-label, multicentre trial of ART interruption in patients who had started treatment early (ClinicalTrials.gov Identifier, NCT00118677).
In "The Curator's Piece," Tea Tupajic and Petra Zanki will hold "a trial against art" for failing to save the world.
