Table 2.
| A. Summary of Post-Randomization CD4%, CD4 Count, Viral Load, Growth, and Morbidity by Arm* | |||
|---|---|---|---|
| Characteristics | Continued Median (IQR) or n (%) N=21 |
TI Median (IQR) or n (%) N=21 |
P-value |
| CD4% | |||
| Randomization [N=21, 21] | 33 (30, 40) | 34 (32, 38) | 0.950 |
| 3-month [N=21, 21] | 37 (29, 42) | 23 (18, 27) | <0.001 |
| 6-month [N=21, 20] | 34 (26, 41) | 26 (24, 37) | 0.155 |
| 9-month [N=21, 21] | 34 (27, 41) | 29 (26, 34) | 0.170 |
| 12-month [N=19, 21] | 35 (25, 42) | 30 (28, 35) | 0.303 |
| 15-month [N=19, 20] | 37 (30, 44) | 32 (29, 38) | 0.172 |
| 18-month [N=18, 21] | 35 (27, 42) | 35 (33, 37) | 0.921 |
| Plasma log10 VL | |||
| Randomization [N=21, 21] | 2.18 (2.18, 2.64) | 2.18 (2.18, 2.71) | 0.655 |
| 03-month [N=20, 21] | 2.18 (2.18, 5.30) | 6.02 (5.42, 6.37) | <0.001 |
| 06-month [N=21, 19] | 2.28 (2.18, 5.29) | 3.21 (2.69, 5.27) | 0.174 |
| 09-month [N=21, 21] | 2.18 (2.18, 5.36) | 3.07 (2.18, 4.87) | 0.506 |
| 12-month [N=19, 21] | 2.18 (2.18, 4.24) | 2.76 (2.18, 3.82) | 0.398 |
| 15-month [N=17, 20] | 2.18 (2.18, 4.38) | 2.30 (2.18, 4.35) | 0.618 |
| 18-month [N=18, 21] | 2.18 (2.18, 4.03) | 2.18 (2.18, 2.96) | 0.920 |
| % with VL>1000 copies/ml | |||
| Randomization [N=21, 21] | 5 (24) | 5 (24) | 1.000 |
| 03-month [N=20, 21] | 7 (35) | 19 (90) | <0.001 |
| 06-month [N=21, 19] | 8 (38) | 12 (63) | 0.205 |
| 09-month [N=21, 21] | 8 (38) | 11 (52) | 0.536 |
| 12-month [N=19, 21] | 6 (32) | 9 (43) | 0.527 |
| 15-month [N=17, 20] | 5 (29) | 7 (35) | 1.000 |
| 18-month [N=18, 21] | 6 (33) | 5 (24) | 0.723 |
| Growth | |||
| Follow-up time since randomization, months | 18.3 (18.0, 18.4) | 18.4 (18.3, 18.5) | |
| Weight for Age z scores | |||
| Randomization [N=21, 21] | −0.47 (−0.87. −0.02) | −0.34 (−0.63, 0.47) | 0.155 |
| 3-month [N=21, 21] | −0.54 (−0.96, −0.07) | −0.31 (−0.53, 0.70) | 0.105 |
| 6-month [N=21, 21] | −0.42 (−0.93, −0.13) | −0.30 (−0.81, 0.47) | 0.297 |
| 12-month [N=20, 21] | −0.54 (−0.98, −0.19) | −0.29 (−0.71, 0.29) | 0.141 |
| 18-month [N=17, 20] | −0.57 (−0.88, −0.28) | −0.17 (−0.56, 0.37) | 0.148 |
| Height for Age z scores | |||
| Randomization [N=21, 21] | −1.33 (−2.04, −1.03) | −0.91 (−1.66, −0.16) | 0.155 |
| 3-month [N=21, 21] | −1.32 (−1.91, −0.93) | −0.94 (−1.67, −0.42) | 0.232 |
| 6-month [N=21, 21] | −1.31 (−1.75, −0.96) | −1.00 (−1.76, −0.21) | 0.237 |
| 12-month [N=20, 21] | −1.14 (−1.87, −0.73) | −0.92 (−1.67, −0.13) | 0.498 |
| 18-month [N=17, 20] | −1.04 (−1.58, −0.59) | −0.78 (−1.62, 0.00) | 0.446 |
|
Morbidity and adverse events |
Incidence per 100 child-years (number of cases) |
Incidence per 100 child-years (number of cases) |
|
| Clinical severe adverse events (per 100 child-years) | 3.3 (1) | 3.1 (1) | 0.972 |
| URTI | 324 (99) | 334 (107) | 0.875 |
| Rash | 68.7 (21) | 84.3 (27) | 0.569 |
| Anemia | 29.4 (9) | 31.2 (10) | 0.957 |
| High cholesterol | 58.9 (18) | 34.3 (11) | 0.032 |
| Diarrhea | 45.8 (14) | 40.6 (13) | 0.774 |
| Pneumonia | 13.1 (4) | 9.37 (3) | 0.603 |
| Lymphadenopathy | 22.9 (7) | 50.0 (16) | 0.087 |
| Death | 3.3 (1) | 0 (0) | 0.293 |
| B. Comparison of TI Children who met ART Re-start Criteria at 3 Months to Those with met ART Re-start Criteria Later | |||
|---|---|---|---|
| Characteristics | Median (IQR) or n (%) Met ART-restart criteria at 3 Months N= 14 |
Median (IQR) or n (%) Did not meet ART- restart criteria at 3 Months N= 7 |
p- value |
| Age at ART (months) | 4.8 (3.8, 7.1) | 5.3 (4.4, 7.3) | 0.654 |
| Growth | |||
| Pre-ART WAZ | −1.64 (−2.51, −0.79) | −1.34 (−2.98, −0.60) | 0.852 |
| Randomization WAZ | −0.29 (−0.63, 0.47) | −0.34 (−0.65, 0.62) | 1.000 |
| Pre-ART HAZ | −1.01 (−2.24, −0.19) | −1.14 (−3.73, −0.35) | 0.794 |
| Randomization HAZ | −0.76 (−1.18, −0.13) | −1.89 (−2.17, −0.76) | 0.073 |
| Pre-ART WHZ | −1.15 (−2.93, 0.21) | −0.54 (−1.62, 0.02) | 0.478 |
| Randomization WHZ | 0.58 (−0.09, 0.69) | 0.98 (0.45, 1.41) | 0.101 |
| CD4% | |||
| Pre-ART CD4% | 19 (15, 23) | 19 (14, 23) | 0.822 |
| CD4% Nadir | 16 (10, 19) | 18 (14, 23) | 0.525 |
| Randomization CD4% | 33 (29, 36) | 39 (33, 41) | 0.043 |
| CD4 Count | |||
| Pre-ART CD4 Count (cells/mL) | 1365 (738, 1760) | 1572 (596, 2140) | 0.654 |
| Randomization CD4 count (cells/µL) | 1390 (1177, 1887) | 1747 (1654, 2238) | 0.073 |
| HIV-1 Viral Load | |||
| Pre-ART viral load (log10) [N=9, 6] | 6.63 (6.30, 6.93) | 6.28 (5.52, 6.83) | 0.556 |
| Randomization viral load | 150 (150, 325) | 150 (150 − 343,305) | 0.328 |
| Enrollment WHO Stage 3/4 [N=10, 6]** | 4 (40) | 3 (50) | 1.000 |
| Randomization WHO Stage I | 14 (100) | 7 (100) | - |
| Randomization Regimen | |||
| PI-regimen | 12 (86) | 4 (57) | 0.280 |
| NNRTI-regimen | 2 (14) | 3 (43) | |
*
intent to treat analyses
**
Excludes infants already on ART at enrollment who did not have this information.