Background
Methods
Study design
Measurements
Statistical analysis
Results
Study population
Pretreatment characteristics
Characteristics | Enrolled children (n = 323) | ||
---|---|---|---|
Boys (n = 168) | Girls (n = 155) |
P-value | |
Age at treatment start, N (%) | |||
<6 months | 41 (24.4) | 61 (39.4) | |
6-12 months | 70 (41.7) | 45 (29.0) |
0.009
|
12-24 months | 57 (33.9) | 49 (31.6) | |
Median (range) in months | 9.6 (2.2-24.2) | 7.9 (2.0-24.9) | 0.098 |
HIV-1 RNA quantity, N (%) | 0.475 | ||
<100,000 copies/ml | 16 (10.6) | 9 (6.8) | |
100,000-750,000 copies/ml | 39 (25.8) | 39 (29.6) | |
≥750,000 copies/ml | 96 (63.6) | 84 (63.6) | |
CD4 count in cells/mm3, Mean (SD) | 1001 (724) | 1011 (786) | 0.909 |
CD4 percent, N (%) | |||
<10 | 30 (19.1) | 25 (17.0) | |
10-14.9 | 35 (22.3) | 26 (17.7) | 0.463 |
≥15 | 92 (58.6) | 96 (65.3) | |
Median (range) | 16.8 (0.8-43.0) | 19.1 (1.2-39.1) | 0.163 |
WHO Stage, N (%) | |||
I/II | 29 (21.0) | 22 (17.5) | 0.465 |
III/IV | 109 (79.0) | 104 (82.5) | |
Weight for age Z-score | |||
Mean (SD) | −2.70 (1.8) | −2.28 (1.6) |
0.041
|
Z-score < −2, N (%) | 98 (66.7) | 71 (49.7) |
0.003
|
Height for age Z-score | |||
Mean (SD) | −3.72 (1.8) | −3.11 (1.6) |
0.003
|
Z-score < −2, N (%) | 125 (86.2) | 108 (76.6) |
0.037
|
Viral load
CD4 percentage and count
Metabolic and laboratory assessments
Measurement | LPV/r (n = 85) | NVP (n = 71) | |||||
---|---|---|---|---|---|---|---|
Boys (n = 41) | Girls (n = 44) |
P-value | Boys (n = 40) | Girls (n = 31) |
P-value | ||
Total Cholesterol, mg/dL | Mean (SD) | 170 (39) | 172 (39) | 0.816 | 163 (25) | 159 (38) | 0.533 |
Acceptable: <170 | N (%) | 24 (58.5) | 21 (47.7) | 0.603 | 29 (72.5) | 23 (74.2) | 0.884 |
Borderline: 170-199 | 10 (24.4) | 14 (31.8) | 8 (20.0) | 5 (16.1) | |||
Elevated: ≥200 | 7 (17.1) | 9 (20.5) | 3 (7.5) | 3 (9.7) | |||
HDL, mg/dL | Mean (SD) | 54 (14) | 48 (12) |
0.044
| 60 (15) | 57 (16) | 0.352 |
Abnormal: <35 | N (%) | 2 (4.9) | 5 (11.4) | 0.277 | 0 (0.0) | 2 (6.4) | 0.103 |
Normal: ≥35 | 39 (95.1) | 39 (88.6) | 40 (100.0) | 29 (93.6) | |||
LDL, mg/dL | Mean (SD) | 98 (31) | 101 (38) | 0.664 | 89 (24) | 87 (29) | 0.738 |
Acceptable: <110 | N (%) | 28 (68.3) | 28 (63.6) | 0.895 | 31 (77.5) | 25 (80.7) | 0.516 |
Borderline: 110-129 | 7 (17.1) | 9 (20.5) | 7 (17.5) | 3 (9.7) | |||
Elevated: ≥130 | 6 (14.6) | 7 (15.9) | 2 (0.5) | 3 (9.7) | |||
Total Cholesterol: HDL Ratio
| Mean (SD) | 3.3 (1.0) | 3.8 (1.1) |
0.049
| 2.8 (0.7) | 3.0 (1.0) | 0.547 |
Triglycerides, mg/dL | Mean (SD) | 88 (34) | 99 (42) | 0.207 | 69 (27) | 74 (32) | 0.457 |
Normal: ≤150 | N (%) | 37 (90.2) | 37 (84.1) | 0.398 | 39 (97.5) | 30 (96.8) | 0.855 |
Abnormal: >150 | 4 (9.8) | 7 (15.9) | 1 (2.5) | 1 (3.2) | |||
C-Reactive Protein, mg/L | Mean (SD) | 3.2 (5.6) | 3.8 (6.5) | 0.453 | 9.5 (23.8) | 9.8 (18.1) | 0.423 |
Normal: ≤3 | N (%) | 33 (80.5) | 36 (81.8) | 0.875 | 27 (67.5) | 19 (61.3) | 0.587 |
Elevated: >3 | 8 (19.5) | 8 (18.2) | 13 (32.5) | 12 (38.7) | |||
Glucose, mg/dL | Mean (SD) | 96.9 (7.1) | 96.4 (7.8) | 0.736 | 97.6 (9.2) | 93.7 (8.5) | 0.070 |
Normal: <110 | N (%) | 80 (98.8) | 41 (100.0) | 0.332 | 74 (98.7) | 39 (97.5) | 0.375 |
Impaired: ≥110 | 1 (1.2) | 0 (0.0) | 1 (1.3) | 1 (2.5) | |||
HOMA-IR
| Mean (SD) | 0.90 (0.5) | 1.16 (0.6) |
0.036
| 1.17 (1.0) | 0.96 (0.6) | 0.289 |
Normal: ≤3.16 | N (%) | 41 (100.0) | 44 (100.0) | 1.0 | 36 (92.3) | 31 (100.0) | 0.115 |
Resistance: >3.16 | 0 (0.0) | 0 (0.0) | 3 (7.7) | 0 (0.0) |
Anthropometrics
Measurement | LPV/r (n = 85) | NVP (n = 71) | ||||
---|---|---|---|---|---|---|
Boys (n = 41) | Girls (n = 44) |
P-value | Boys (n = 40) | Girls (n = 31) |
P-value | |
MUAC, cm | 16.1 (15.2) | 15.5 (2.0) | 0.288 | 15.2 (1.8) | 15.1 (2.1) | 0.844 |
MWC: MHC Ratio | 1.25 (1.9) | 0.93 (0.1) | 0.287 | 0.95 (0.1) | 0.95 (0.1) | 0.773 |
SFS, mm | 41.9 (12.1) | 44.0 (10.1) | 0.408 | 37.2 (9.7) | 41.3 (10.3) | 0.120 |
%BF by BIA | 14.5 (6.2) | 19.2 (7.0) |
0.002
| 10.9 (7.6) | 17.9 (6.9) |
0.0002
|
Extremity Fat Area
| ||||||
Arm Fat Area, cm2
| 5.52 (2.0) | 6.05 (2.2) | 0.259 | 4.91 (1.3) | 5.65 (2.0) | 0.063 |
% of Fat in Arm | 26.6 (5.5) | 31.5 (9.6) |
0.006
| 27.2 (8.2) | 30.9 (8.2) | 0.063 |
Leg Fat Area, cm2
| 14.9 (5.5) | 16.5 (6.5) | 0.236 | 12.3 (4.4) | 15.2 (6.1) |
0.025
|
% of Fat in Leg | 20.1 (5.6) | 23.4 (7.4) |
0.028
| 17.7 (4.5) | 21.6 (6.4) |
0.006
|
Regional Fat Proportion of Total Body Fat
| ||||||
Arm: [(BSF + TSF)/SFS] | 0.30 (0.05) | 0.30 (0.04) | 0.985 | 0.31 (0.05) | 0.29 (0.03) | 0.197 |
Trunk: [(SSF + SISF + USF)/SFS] | 0.46 (0.07) | 0.45 (0.06) | 0.484 | 0.47 (0.05) | 0.47 (0.05) | 0.658 |
Leg: [MTSF/SFS] | 0.24 (0.04) | 0.25 (0.04) | 0.297 | 0.22 (0.03) | 0.24 (0.04) |
0.026
|
Trunk-Extremity Skinfold Ratios
| ||||||
Trunk-Arm: [(SSF + SISF)/(BSF + TSF + SSF + SISF)] | 0.49 (0.06) | 0.50 (0.06) | 0.652 | 0.50 (0.04) | 0.51 (0.06) | 0.306 |
Trunk-Leg: [(SSF + SISF)/(MTSF + SSF + SISF)] | 0.55 (0.06) | 0.55 (0.07) | 0.978 | 0.58 (0.04) | 0.57 (0.06) | 0.278 |