Table 3:
Frequency of serious adverse events and adverse events occurring during the study
| No. (%) of patients | ||
|---|---|---|
| Adverse event | TDF/FTC/LPRr (n = 5) | Placebo (n = 6) |
| Gastrointestinal intolerance (combinations of the following: loss of appetite, nausea, vomiting, epigastric pain or reflux, abdominal cramps, flatulence, dysgeusia, diarrhea, change in bowel pattern) | 4 (80) | 3 (50) |
| Fatigue | 1 (20) | 1 (17) |
| Intermittent shortness of breath | 1 (20) | 1 (17) |
| Flu-like symptoms | 1 (20) | – |
| Increased frequency of headaches | – | 1 (17) |
| Generalized arthralgias | – | 2 (33) |
| Dehydration | – | 2 (33) |
| Hypercholesterinemia | – | 1 (17) |
| Strep throat | – | 1 (17) |
| Anemia | – | 1 (17) |
| Hot flushes | – | 1 (17) |
| Leg cramps | – | 1 (17) |
| Urinary tract infection | – | 1 (17) |
| Dry mouth | – | 1 (17) |
| Change in sleep pattern | – | 1 (17) |
| Serious adverse events (hematemesis from esophageal varices) | – | 1 (17) |
Abbreviations: TDF/FTC/LPRr = combination tenofovir-emtricitabine (TDF/FTC) and lopinavir-ritonavir (LPRr)