LPV/r + TDF (n=72) LPV/r + 2 NRTIs (n=80)
treatment exposure (weeks) 54.33 54.00
any AE 61 (84.7%) 67 (83.8%)
any drug-related AE 39 (54.2%) 52 (65.0%)
any serious AE 10 (13.9%) 7 (8.8%)
any drug-related serious AE 0 2 (2.5%)
any AE causing D/C 9 (12.5%) 6 (7.5%)
any AE causing death
Dyspnea and chest pain
Suspect lymphoproliferative disorder
2 (2.8%)
1
1
0
GI Disorders 37 (51.4%) 33 (41.3%)
Diarrhoea 28 (38.9%) 23 (28.8%)
Nausea 6 (8.3%) 6 (7.5%)
Vomiting 7 (9.7%) 6 (7.5%)
General disorders 10 (13.9%) 20 (25%)
Fever 6 (8.3%) 12 (15.0%)
Asthenia 3 (4.2%) 8 (10.0%)
Other    
Headache 3 (4.2%) 6 (7.5%)
Cough 5 (6.9%) 7 (8.8%)
METABOLIC DISORDERS 14 (19.4%) 23 (28.8%)
Dyslipidemia 1 (1.4%) 4 (5.0%)
Hypertriglyceridemia 9 (12.5%) 14 (17.5%)
Total cholesterol Grade III-IV 3 (4.2%) 7 (8.8%)
Triglycerides Grade III-IV 5 (6.9%) 9 (11.3%)
AE, Adverse Event; D/C, discontinuation; LPV/r, Lopinavir/ritonavir; NRTI,
Nucleoside Reverse Transcriptase Inhibitor; TDF, Tenofovir Disoproxyl Fumarate.
Table 2: Summary of safety. Adverse events with incidence >5% in either treatment arm, Drug-related Serious Adverse events and Adverse events causing death are presented.