TABLE 1.
Planned study design
| Treatment sequenceb | Study treatment (days 1 to 14) fora:
|
||
|---|---|---|---|
| Period 1 | Period 2c | Period 3 | |
| 1 | A | B | C |
| 2 | B | C | A |
| 3 | C | A | B |
| 4 | A | C | B |
| 5 | B | A | C |
| 6 | C | B | A |
a
Treatment A was FPV 700 mg BID plus RTV 100 mg BID, treatment B was FPV 1,400 mg BID plus RTV 100 mg BID, and treatment C was FPV 1,400 mg BID plus RTV 200 mg BID. A 21- to 28-day washout period occurred between each two periods.
b
There were seven subjects in each sequence.
c
The study was prematurely terminated on day 9 of period 2.