Table 1.
Demographics of Study Participants
| Variable | HIV-Uninfected | HIV-Infected |
||
|---|---|---|---|---|
| EFV-Based ART | LPV/r-Based ART | NVP-Based ART | ||
| Total episodes, No. | 188 | 182 | ||
| Intensive PK sampling episodes (n = 145) | 54 | 31 | 30 | 30 |
| Sparse PK sampling episodes (n = 225) | 134 | 19 | 40 | 32 |
| Age, y, median (range) | 3.5 (1.1–7.9) | 5.6 (3.1–8.6) | 4.6 (1.4–8.0) | 4.6 (1.4–8.0) |
| Weight, kg, median (range) | 13.8 (9.8–27) | 17.6 (11.4–25.1) | 15.1 (7.7–23.7) | 16.3 (8.5–30.0) |
| Parasite density at diagnosis, geometric mean µL−1 (95% CI)a | 16 189 (12 042–21 763) | 11 671 (6389–21 321) | 6917 (3839–12 463) | 10 568 (5746–19 435) |
| Gametocytes present at diagnosisb | 11.2% | 22.0% | 7.1% | 14.8% |
| Gametocytes present at any point from day 1 to 28c | 17.0% | 36.0% | 20.0% | 29.6% |
| Hemoglobin at diagnosis, g/dL, median (IQR) | 10.8 (9.7–11.4) | 10.5 (9.7–11.3) | ||
| Total lumefantrine dose, mg/kg, median (range) | 65.4 (48.3–96.0) | 74.0 (48.3–96.4) | ||
| Total artemether dose, mg/kg, median (range) | 10.9 (8.1–16.0) | 12.3 (8.1–16.1) | ||
There were no differences in demographic parameters between the intensive and sparse PK sampling cohorts.
Abbreviations: ART, antiretroviral therapy; CI, confidence interval; EFV, efavirenz; HIV, human immunodeficiency virus; IQR, interquartile range; LPV/r, lopinavir/ritonavir; NVP, nevirapine; PK, pharmacokinetic.
a Geometric mean parasite density on the day of diagnosis was significantly different in those on LPV/r vs HIV-uninfected children (P = .002; adjusted for repeated measures); differences not significant for other group comparisons.
b P = .032 for gametocytemia on the day of diagnosis in those on EFV- vs LPV/r-based ART; adjusted for repeated measures.
c Gametocytemia newly developing on days 1–28 was significantly more common in both children on EFV- or NVP-based ART compared with HIV-uninfected children (P = .008; adjusted for repeated measures).