Superiority of directly administered antiretroviral therapy over self-administered therapy among HIV-infected drug users: a prospective, randomized, controlled trial.
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Date
2007-08-22
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Abstract
BACKGROUND Directly administered antiretroviral therapy DAART is one approach to improve treatment adherence among human immunodeficiency virus HIV infected drug users METHODS In this randomized controlled trial ClinicalTrials gov identifier NCT00367172 the biological outcomes of a 6 month community intervention of DAART were compared with those of self administered therapy among HIV infected drug users Patients randomized to receive DAART received supervised therapy 5 days per week from workers in a mobile health care van The primary outcome using an intention to treat approach was the proportion of patients achieving either a reduction in HIV 1 RNA level of or 1 0 log10 copies mL or an HIV 1 RNA level Under or 400 copies mL at 6 months Secondary outcomes included the mean change from baseline in HIV 1 RNA level and CD4 T lymphocyte count RESULTS Of the 141 patients who met the entry criteria 88 were randomized to receive DAART and 53 were randomized to receive self administered therapy 74 84 of 88 of the patients randomized to receive DAART accepted the intervention Of the 74 patients who initiated DAART 51 69 completed the full 6 month intervention At the end of 6 months a significantly greater proportion of the DAART group achieved the primary outcome 70 5 vs 54 7 P 02 Additionally compared with patients receiving self administered therapy patients receiving DAART demonstrated a significantly greater mean reduction in HIV 1 RNA level 1 16 log10 copies mL vs 0 29 log10 copies mL P 03 and mean increase in CD4 T lymphocyte count 58 8 cells microL vs 24 0 cells microL P 002 CONCLUSIONS This randomized controlled trial was to our knowledge the first to demonstrate the effectiveness of DAART at improving 6 month virologic outcomes among drug users These results suggest that DAART should be more widely available in HIV treatment programs that target drug users who have poor adherence to treatment