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Impact of Directly Observed Therapy on Outcomes in HIV Clinical Trials M. FISCHL1*, A. RODRIGUEZ1, E. SCERPELLA1, R. MONROIG1, L. THOMPSON1, and D. RECHTINE2.
1Univ. of Miami and 2Dept. of Corrections, Orlando, FL
Objectives: To assess directly observed therapy (DOT) in HIV clinical
trials.
Methods: Treatment-naive subjects enrolled in 4 clinical trials
conducted simultaneously at the AIDS Clinical Research Unit (ACRU) and
Dept. of Corrections (DOC) were included. Subjects received study meds
as DOT in the DOC and as self-administered therapy (SAT) in the ACRU.
Regimens included three or four drugs, 2NRTIs with a PI, an NNRTI, or
abacavir. Analysis used an intent-to-treat approach.
Results: A total of 84 subjects were included, 42 each in the DOT
and SAT groups. DOT subjects were more likely to be men (93% vs 79%),
black (86% vs 17%), and use drugs (31% vs 2%) and had lower baseline CDR
cells (261 vs 375 cells/mm3) and higher HIV RNA levels (4.0
vs 3.2 log10). The proportion of subjects with declines in
HIV RNA was higher in the DOT group (p<0.01, Table). A greater mean increase
in CD4 cells at 48 wks was also noted for the DOT group (p<0.02, 183 -vs.
136 cells/mm3). DOT subjects experienced less grade 3/4 toxicities
(p<0.01, 15% vs 35%).
Conclusions: Despite lower CD4 cell and higher HIV RNA levels,
subjects receiving DOT had both a more rapid and a greater overall decline
in HIV RNA during treatment. This was associated with a greater increase
in CD4 cells and less serious toxicities.
Key Words: directedly observed therapy, HIV RNA, prisoners
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