Table 1.
Summary of reasons for and timing of participant withdrawal from the study
Arm 1 |
Arm 2 |
|||
---|---|---|---|---|
Reason for withdrawal | Days 1–14 Saquinavir/Ritonavir (N = 14) | Days 15–28 Saquinavir/Ritonavir + Rifampin (N = 8) | Days 1–14 Rifampin (N = 14) | Days 15–28 Rifampin + Saquinavir/Ritonavir (N = 9) |
Adverse event | 1 | 1 | — | 6 |
Consent withdrawn | 1 | — | 1 | 1 |
Premature study termination* | 4† | 7 | 4† | 2 |
Total number discontinued | 6 | 8 | 5 | 9 |
At the time of study termination, these patients were still receiving trial treatment.
Two participants discontinued prior to receiving 14 days of the study drug and two participants received the full 14 days and completed a full PK profile.