TABLE 1.
Summary of the most commonly reported adverse events following administration of saquinavir-SGC alone or in combination with ritonavir for 13 days in healthy HIV-negative volunteers
| Adverse event | No. of subjects reporting event who were in groupa:
|
||||
|---|---|---|---|---|---|
| A | B | C | D | E | |
| Bloating | 4 | 2 | 1 | 2 | 5 |
| Constipation | 0 | 0 | 0 | 3 | 0 |
| Diarrhea | 0 | 3 | 4 | 4 | 4 |
| Fatigue | 6 | 7 | 3 | 3 | 5 |
| Flatulence | 5 | 4 | 5 | 3 | 5 |
| Headache | 4 | 4 | 5 | 4 | 4 |
| Irritability | 2 | 2 | 3 | 0 | 0 |
| Nausea | 5 | 5 | 5 | 6 | 5 |
a
Dosing for groups was as follows: for group A (n = 8), 1,200 mg of saquinavir-SGC three times a day; for group B (n = 8), 1,200 mg of saquinavir-SGC plus 100 mg of ritonavir (both once daily); for group C (n = 10), 1,600 mg of saquinavir-SGC plus 100 mg of ritonavir (both once daily); for group D (n = 9), 1,800 mg of saquinavir-SGC plus 100 mg of ritonavir (both once daily); and for group E (n = 9), 1,200 mg of saquinavir-SGC plus 200 mg of ritonavir (both once daily).