Background:  We assessed the 96-week efficacy and safety of double-boosted saquinavir (SQV)/lopinavir (LPV)/ritonavir (r) combination in children who have failed NRTI/NNRTI-based regimens.
Methods:  In this 96-week prospective study, 50 NRTI/NNRTI pre-treated children in Bangkok (n = 20) and Khon Kaen (n = 30), Thailand were treated with twice-daily SQV-mesylate capsule and LPV/r. CD4, viral load, and fasting lipids were monitored every 12 weeks. Lipodystrophy was assessed by standard questionnaire every 24 weeks. Having 2 consecutive viral load >400 copies/mL after week 12 was defined as viral load failure. Intent-to-treat analysis was performed.
Results:  Median values at baseline were age 9.3 years (IQR 7.1 to 11.2), viral load 4.8 log₁₀ (IQR 4.5 to 5.1), CD4 7% (IQR 3 to 9.5), CD4 count 160 (IQR 43.5 to 286.5) cells/mm³, and triglycerides and LDL and HDL cholesterol were 104 and 78 and 44 mg/dL, respectively. Percentage of CDC N:A:B:C = 4:14:68:14. The children from Khon Kaen site had higher viral load (4.9 log₁₀ vs 4.7log₁₀, p = 0.037). Lipoatrophy at arm and face were reported in 12% and 8%, respectively, while 2% reported lipohypertrophy at abdomen. At 96 weeks, 3 children died from bacterial infection; 2 stopped ART, 1 from intolerance and the other from noncompliance; no child had HIV disease progression. Median CD4% and CD4 count rise were 14% (IQR 7 to 19) and 558 (305 to 782) cells/mm³, and median viral load reduction was –2.8 log₁₀ (IQR –3.3 to –2.1), all p <0.001; 39 (78%) and 37(74%) children had viral load <400 and <50 copies/mL, respectively, with differences between sites (Bangkok, 90% and 90%; Khon Kaen, 70% and 63.3%, respectively). Viral load failure was seen in 1 of 20 in Bangkok and 5 of 30 in Khon Kaen; 3 failures had poor adherence. ART-related adverse events of any grade were seen in 10 children (20%); grade I-II 61%, grade III-IV 39%. The most common adverse events were diarrhea, vomiting, and elevated triglycerides. Median triglyceride, LDL, and HDL changes (mg/dL) were +12 (IQR –17 to 50) p = NS; +11 (IQR –13.5 to 22) p = NS; and +14 (IQR 1 to 25.5) p = 0.004, respectively. Approximately half reported no change in body shape; but, 33, 43, and 39% reported fatter arm, face, and abdomen, respectively. 
Conclusions:  Double-boosted SQV/LPV/r showed significant CD4 rise and viral load decline at 96 weeks. No progression of HIV disease was seen. Mild ART-related adverse events were common. HDL was significantly increased.