Report 3: 7th Conference on Retroviruses and Opportunistic Infections,
San Francisco, Monday Jan 31
The Importance of Adherence -- Impact of Directly Observed Therapy on Outcomes in HIV Clinical Trials.
M. FISCHL*^{1}, A. RODRIGUEZ^{1}, E. SCERPELLA^{1}, R. MONROIG^{1}, L. THOMPSON^{1}, and D. RECHTINE^{2}. ^{1}Univ. of Miami and ^{2}Dept. of
Corrections, Orlando, FL.
The putpose of this study was to assess directly observed therapy (DOT) in HIV clinical trials.
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.
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/mm^{3}) and higher HIV RNA levels (4.0 vs 3.2 log_{10}). 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/mm^{3}). DOT subjects experienced less grade 3/4 toxicities (p<0.01, 15% vs 35%).
| wk4 | wk8 | wk 16 | wk24 | wk32 | wk40 | wk48 | |
| DOT <50 | 14% | 33% | 49% | 84% | 89% | 83% | 85% |
| SAT <50 | 15% | 23% | 46% | 50% | 48% | 58% | 50% |
| DOT <400 | 48% | 73% | 95% | 97% | 100% | 94% | 100% |
| SAT <400 | 36% | 65% | 83% | 85% | 87% | 77% | 68% |
The authors concluded that 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.