Table 2.
LPV/r disposition among eligible randomized subjects
| Status (Reason) | LPV/r BID (n=159) |
LPV/r QD (n=161) |
|---|---|---|
| Completed Study on LPV/r | 117 (74%) | 109 (68%) |
| Never Started LPV/r | 1 (1%) | 0 (0%) |
| Discontinued LPV/r | 41 (26%) | 52 (32%) |
| Toxicity | 10 | 17 |
| Non-compliant* | 10 | 14 |
| Lost to follow-up | 6 | 5 |
| Incarcerated | 5 | 3 |
| Unable to Attend Clinic | 4 | 2 |
| Severely Debilitated | 3 | 3 |
| Died** | 1 | 1 |
| Switched dose schedule | 0 | 1 |
| Other† | 2 | 6 |
*
Non-compliant with study visits (3), with study medication (8), with both study visits and medication (13).
**
Three additional subjects died after LPV/r discontinuation (see Figure 1).
†
Volume/timing of meds (3), pregnancy, non-protocol defined clinical event, treatment not working, withdrew consent, disallowed medication (1 each).