TABLE 1.
Study enrollment, withdrawal, and completion ratesa
Subject characteristic | No. of subjects
|
||
---|---|---|---|
Regimen A | Regimen B | Total | |
Subjects who were randomized | 17 | 17 | 34 |
Subject withdrawal for acute illness before treatment with a single drug was initiated | 1 | 1 | 2 |
Subjects evaluable for single-drug tolerance | 16 | 16 | 32 |
Subject withdrawal of consent before two drug combination was initiated | 1 | 1 | 2 |
Subject noncompliance before two-drug combination was initiated | 1 | 0 | 1 |
Subjects evaluable for combination drug tolerance | 14 | 15 | 29 |
Subject withdrawal for adverse event after two-drug combination was initiated | 1 | 1 | 2 |
Subject noncompliance during two-drug combination | 1 | 0 | 1 |
Subjects completing the study | 12 | 14 | 26 |
Subjects for whom no pharmacokinetic data were available because of technical problems | 1 | 0 | 1 |
Subjects for whom data were evaluable for pharmacokinetic analysis | 11 | 14 | 25 |
Regimen A, clarithromycin on days 1 to 14 and both study drugs on days 15 to 42; regimen B, rifabutin on days 1 to 14 and both study drugs on days 15 to 42.