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Background:  Methadone clinics provide settings where DAART may be feasible in HIV-infected drug users (DUs), but there are few data on the potential effectiveness of this approach.

Methods:  Since April 2001, DUs who were receiving HIV care and methadone therapy at Johns Hopkins were enrolled in a prospective Directly Administered Antiretroviral Therapy (DAART) Study. Morning doses of antiretroviral therapy (ART) were supervised in participants (up to 7 days a week) and evening doses were pre-packaged and self-administered. Two groups of concurrent comparison patients, who self-administered ART, were randomly selected from the same HIV clinic population as DAART participants:  patients with a history of DU who were receiving methadone therapy (DU-control), and patients with no history of DU (non-DU control).

Results:  To date, 50 patients have been enrolled in DAART:  these were matched to 90 DU-control and 146 non-DU control patients. The percentage of patients with prior ART exposure (60%), median baseline HIV RNA levels (4.8 log copies/mL), and median baseline CD4 cell counts (167/mm³) were similar in the groups. The figure below shows the percentage achieving HIV-RNA <50 copies/mL in an intent-to-treat, missing = failure analysis. At 6 and 12 months, DAART participants were significantly more likely to achieve viral suppression than DU-controls (p <0.001 and p = 0.02, respectively), and were somewhat more likely to achieve viral suppression than non-DU controls (p = 0.04 and p = 0.45, respectively). Median increases in CD4 cells at 12 months were similar in the DAART group (60/mm³), DU-control (37/mm³), and non-DU control (54/mm³).

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Conclusions:  These results suggest that DAART is feasible in a methadone clinic setting and that this strategy leads to improved rates of viral suppression compared to self-administered therapy.

Keywords: directly observed therapy; methadone; drug abusers