Baseline Characteristics at Time of Malaria Diagnosis in Children Enrolled in the Parasite Clearance and Intensive Pharmacokinetics Cohort
| Parasite Clearance Cohort (n = 110 Children) . | |||||
|---|---|---|---|---|---|
| Variable . | HIV-Uninfected . | HIV-Infecteda . | |||
| HIV-Infected . | Efavirenz-Based ART . | Nevirapine- Based ART . | Lopinavir/ Ritonavir-Based ART . | ||
| . | n = 83 . | n = 27 . | n = 9 . | n = 8 . | n = 10 . |
| Age (median, years; range) | 3.5 (1.1–7.9) | 4.9 (2.3–6.7) | 5.3 (3.3–6.3) | 4.0 (2.3–5.8) | 5.0 (2.4–6.7) |
| Weightb (median, kg; range) | 13.7 (10.0–27.0) | 16.5 (10.7–20.5) | 17.5 (12.3–18.0) | 12.6 (10.9–20.5) | 17.0 (10.7–19.4) |
| Parasite density at diagnosis (geometric mean µL−1; 95% CI) | 14387 (8893–23273) | 18373 (7857–42965) | 22628 (5483–93386) | 50147 (19791–127062)* | 6822 (987–47176) |
| Gametocytes present at diagnosis | 10.8% | 18.5% | 11.1% | 37.5% | 10.0% |
| Hemoglobin at diagnosis (median, g/dL; IQR) | 10.9 (9.9–11.6) | 10.7 (9.9–11.7) | 10.4 (10.2–10.9) | 10.0 (9.4–11.3) | 11.5 (10.6–12)* |
| Total artemether dose (median, mg/kg; range) | 11.4 (8.0–16.0) | 12.7 (8.1–16.0) | 13.3 (8.1–16.0) | 11.0 (8.6–13.8) | 13.0 (8.5–14.6) |
| Parasite clearance slope half-life (median, hours; IQR)c | 2.80 (2.38–3.36) | 3.51 (2.98–4.03) | 3.44 (3.04–4.01)d | 3.59 (2.46–6.17)d | 3.48 (2.40–4.03) |
| Intensive Pharmacokinetics Cohort (n = 142 Children)e | |||||
| Variable | HIV-Uninfected | HIV-Infected | |||
| HIV-Infected | Efavirenz-Based ART | Nevirapine- Based ART | Lopinavir/Ritonavir-Based ART | ||
| n = 51 | n = 91 | n = 31 | n = 30 | n = 30 | |
| Age (median, years; range) | 3.8 (1.4–7.7) | 5.0 (1.4–8.6) | 6.0 (3.1–8.6) | 5.0 (1.4–8.0) | 4.5 (1.6–7.8) |
| Weight (median, kg; range) | 14.6 (9.8–26) | 16.4 (7.7–30) | 18.0 (11.4–25.1) | 16.4 (8.5–30.0) | 15.8 (7.7–23.4) |
| Parasite density at diagnosis (geometric mean µL−1; 95% CI) | 11956 (6708–21309) | 7742 (4777–12549) | 10993 (4922–24554) | 7368 (2911–18646) | 5665 (2398–13382) |
| Hemoglobin at diagnosis (median, g/dL; IQR) | 11.6 (9.6–14.0) | 10.4 (9.7–10.9) | 12.4 (10.6–14.3) | 12.2 (9.8–14.1) | 13.1 (9.5–14.6) |
| Total artemether dose (median, mg/kg; range) | 11.6 (8.1–16.0) | 12.4 (8.2–16.0) | 12.4 (8.4–16.0) | 12.2 (8.3–15.4) | 13.0 (8.2–15.9) |
| Parasite Clearance Cohort (n = 110 Children) . | |||||
|---|---|---|---|---|---|
| Variable . | HIV-Uninfected . | HIV-Infecteda . | |||
| HIV-Infected . | Efavirenz-Based ART . | Nevirapine- Based ART . | Lopinavir/ Ritonavir-Based ART . | ||
| . | n = 83 . | n = 27 . | n = 9 . | n = 8 . | n = 10 . |
| Age (median, years; range) | 3.5 (1.1–7.9) | 4.9 (2.3–6.7) | 5.3 (3.3–6.3) | 4.0 (2.3–5.8) | 5.0 (2.4–6.7) |
| Weightb (median, kg; range) | 13.7 (10.0–27.0) | 16.5 (10.7–20.5) | 17.5 (12.3–18.0) | 12.6 (10.9–20.5) | 17.0 (10.7–19.4) |
| Parasite density at diagnosis (geometric mean µL−1; 95% CI) | 14387 (8893–23273) | 18373 (7857–42965) | 22628 (5483–93386) | 50147 (19791–127062)* | 6822 (987–47176) |
| Gametocytes present at diagnosis | 10.8% | 18.5% | 11.1% | 37.5% | 10.0% |
| Hemoglobin at diagnosis (median, g/dL; IQR) | 10.9 (9.9–11.6) | 10.7 (9.9–11.7) | 10.4 (10.2–10.9) | 10.0 (9.4–11.3) | 11.5 (10.6–12)* |
| Total artemether dose (median, mg/kg; range) | 11.4 (8.0–16.0) | 12.7 (8.1–16.0) | 13.3 (8.1–16.0) | 11.0 (8.6–13.8) | 13.0 (8.5–14.6) |
| Parasite clearance slope half-life (median, hours; IQR)c | 2.80 (2.38–3.36) | 3.51 (2.98–4.03) | 3.44 (3.04–4.01)d | 3.59 (2.46–6.17)d | 3.48 (2.40–4.03) |
| Intensive Pharmacokinetics Cohort (n = 142 Children)e | |||||
| Variable | HIV-Uninfected | HIV-Infected | |||
| HIV-Infected | Efavirenz-Based ART | Nevirapine- Based ART | Lopinavir/Ritonavir-Based ART | ||
| n = 51 | n = 91 | n = 31 | n = 30 | n = 30 | |
| Age (median, years; range) | 3.8 (1.4–7.7) | 5.0 (1.4–8.6) | 6.0 (3.1–8.6) | 5.0 (1.4–8.0) | 4.5 (1.6–7.8) |
| Weight (median, kg; range) | 14.6 (9.8–26) | 16.4 (7.7–30) | 18.0 (11.4–25.1) | 16.4 (8.5–30.0) | 15.8 (7.7–23.4) |
| Parasite density at diagnosis (geometric mean µL−1; 95% CI) | 11956 (6708–21309) | 7742 (4777–12549) | 10993 (4922–24554) | 7368 (2911–18646) | 5665 (2398–13382) |
| Hemoglobin at diagnosis (median, g/dL; IQR) | 11.6 (9.6–14.0) | 10.4 (9.7–10.9) | 12.4 (10.6–14.3) | 12.2 (9.8–14.1) | 13.1 (9.5–14.6) |
| Total artemether dose (median, mg/kg; range) | 11.6 (8.1–16.0) | 12.4 (8.2–16.0) | 12.4 (8.4–16.0) | 12.2 (8.3–15.4) | 13.0 (8.2–15.9) |
Abbreviations: ART, antiretroviral therapy; CI, confidence interval; HIV, human immunodeficiency virus; IQR, interquartile range; PK, pharmacokinetics.
NOTE: Children could only participate in each cohort for a single episode of malaria, and no episodes contributed data to both cohorts.
*Signifies that P value <.05 for comparison of parameter of interest between parasite clearance and intensive PK cohorts.
a96.6% of HIV-infected children were on daily trimethoprim-sulfamethoxazole prophylaxis.
bNote that children must have been ≥10 kg to be eligible for parasite clearance study enrollment, but could be ≥6 kg for intensive cohort enrollment.
cComparison parasite clearance slope half-lives of HIV-infected (n = 22) and HIV-uninfected children (n = 77), P = .003.
dn = 7 for parameter estimate.
eData from the intensive cohort has been previously published and is provided here to enable comparison between the demographics of the parasite clearance cohort.
Baseline Characteristics at Time of Malaria Diagnosis in Children Enrolled in the Parasite Clearance and Intensive Pharmacokinetics Cohort
| Parasite Clearance Cohort (n = 110 Children) . | |||||
|---|---|---|---|---|---|
| Variable . | HIV-Uninfected . | HIV-Infecteda . | |||
| HIV-Infected . | Efavirenz-Based ART . | Nevirapine- Based ART . | Lopinavir/ Ritonavir-Based ART . | ||
| . | n = 83 . | n = 27 . | n = 9 . | n = 8 . | n = 10 . |
| Age (median, years; range) | 3.5 (1.1–7.9) | 4.9 (2.3–6.7) | 5.3 (3.3–6.3) | 4.0 (2.3–5.8) | 5.0 (2.4–6.7) |
| Weightb (median, kg; range) | 13.7 (10.0–27.0) | 16.5 (10.7–20.5) | 17.5 (12.3–18.0) | 12.6 (10.9–20.5) | 17.0 (10.7–19.4) |
| Parasite density at diagnosis (geometric mean µL−1; 95% CI) | 14387 (8893–23273) | 18373 (7857–42965) | 22628 (5483–93386) | 50147 (19791–127062)* | 6822 (987–47176) |
| Gametocytes present at diagnosis | 10.8% | 18.5% | 11.1% | 37.5% | 10.0% |
| Hemoglobin at diagnosis (median, g/dL; IQR) | 10.9 (9.9–11.6) | 10.7 (9.9–11.7) | 10.4 (10.2–10.9) | 10.0 (9.4–11.3) | 11.5 (10.6–12)* |
| Total artemether dose (median, mg/kg; range) | 11.4 (8.0–16.0) | 12.7 (8.1–16.0) | 13.3 (8.1–16.0) | 11.0 (8.6–13.8) | 13.0 (8.5–14.6) |
| Parasite clearance slope half-life (median, hours; IQR)c | 2.80 (2.38–3.36) | 3.51 (2.98–4.03) | 3.44 (3.04–4.01)d | 3.59 (2.46–6.17)d | 3.48 (2.40–4.03) |
| Intensive Pharmacokinetics Cohort (n = 142 Children)e | |||||
| Variable | HIV-Uninfected | HIV-Infected | |||
| HIV-Infected | Efavirenz-Based ART | Nevirapine- Based ART | Lopinavir/Ritonavir-Based ART | ||
| n = 51 | n = 91 | n = 31 | n = 30 | n = 30 | |
| Age (median, years; range) | 3.8 (1.4–7.7) | 5.0 (1.4–8.6) | 6.0 (3.1–8.6) | 5.0 (1.4–8.0) | 4.5 (1.6–7.8) |
| Weight (median, kg; range) | 14.6 (9.8–26) | 16.4 (7.7–30) | 18.0 (11.4–25.1) | 16.4 (8.5–30.0) | 15.8 (7.7–23.4) |
| Parasite density at diagnosis (geometric mean µL−1; 95% CI) | 11956 (6708–21309) | 7742 (4777–12549) | 10993 (4922–24554) | 7368 (2911–18646) | 5665 (2398–13382) |
| Hemoglobin at diagnosis (median, g/dL; IQR) | 11.6 (9.6–14.0) | 10.4 (9.7–10.9) | 12.4 (10.6–14.3) | 12.2 (9.8–14.1) | 13.1 (9.5–14.6) |
| Total artemether dose (median, mg/kg; range) | 11.6 (8.1–16.0) | 12.4 (8.2–16.0) | 12.4 (8.4–16.0) | 12.2 (8.3–15.4) | 13.0 (8.2–15.9) |
| Parasite Clearance Cohort (n = 110 Children) . | |||||
|---|---|---|---|---|---|
| Variable . | HIV-Uninfected . | HIV-Infecteda . | |||
| HIV-Infected . | Efavirenz-Based ART . | Nevirapine- Based ART . | Lopinavir/ Ritonavir-Based ART . | ||
| . | n = 83 . | n = 27 . | n = 9 . | n = 8 . | n = 10 . |
| Age (median, years; range) | 3.5 (1.1–7.9) | 4.9 (2.3–6.7) | 5.3 (3.3–6.3) | 4.0 (2.3–5.8) | 5.0 (2.4–6.7) |
| Weightb (median, kg; range) | 13.7 (10.0–27.0) | 16.5 (10.7–20.5) | 17.5 (12.3–18.0) | 12.6 (10.9–20.5) | 17.0 (10.7–19.4) |
| Parasite density at diagnosis (geometric mean µL−1; 95% CI) | 14387 (8893–23273) | 18373 (7857–42965) | 22628 (5483–93386) | 50147 (19791–127062)* | 6822 (987–47176) |
| Gametocytes present at diagnosis | 10.8% | 18.5% | 11.1% | 37.5% | 10.0% |
| Hemoglobin at diagnosis (median, g/dL; IQR) | 10.9 (9.9–11.6) | 10.7 (9.9–11.7) | 10.4 (10.2–10.9) | 10.0 (9.4–11.3) | 11.5 (10.6–12)* |
| Total artemether dose (median, mg/kg; range) | 11.4 (8.0–16.0) | 12.7 (8.1–16.0) | 13.3 (8.1–16.0) | 11.0 (8.6–13.8) | 13.0 (8.5–14.6) |
| Parasite clearance slope half-life (median, hours; IQR)c | 2.80 (2.38–3.36) | 3.51 (2.98–4.03) | 3.44 (3.04–4.01)d | 3.59 (2.46–6.17)d | 3.48 (2.40–4.03) |
| Intensive Pharmacokinetics Cohort (n = 142 Children)e | |||||
| Variable | HIV-Uninfected | HIV-Infected | |||
| HIV-Infected | Efavirenz-Based ART | Nevirapine- Based ART | Lopinavir/Ritonavir-Based ART | ||
| n = 51 | n = 91 | n = 31 | n = 30 | n = 30 | |
| Age (median, years; range) | 3.8 (1.4–7.7) | 5.0 (1.4–8.6) | 6.0 (3.1–8.6) | 5.0 (1.4–8.0) | 4.5 (1.6–7.8) |
| Weight (median, kg; range) | 14.6 (9.8–26) | 16.4 (7.7–30) | 18.0 (11.4–25.1) | 16.4 (8.5–30.0) | 15.8 (7.7–23.4) |
| Parasite density at diagnosis (geometric mean µL−1; 95% CI) | 11956 (6708–21309) | 7742 (4777–12549) | 10993 (4922–24554) | 7368 (2911–18646) | 5665 (2398–13382) |
| Hemoglobin at diagnosis (median, g/dL; IQR) | 11.6 (9.6–14.0) | 10.4 (9.7–10.9) | 12.4 (10.6–14.3) | 12.2 (9.8–14.1) | 13.1 (9.5–14.6) |
| Total artemether dose (median, mg/kg; range) | 11.6 (8.1–16.0) | 12.4 (8.2–16.0) | 12.4 (8.4–16.0) | 12.2 (8.3–15.4) | 13.0 (8.2–15.9) |
Abbreviations: ART, antiretroviral therapy; CI, confidence interval; HIV, human immunodeficiency virus; IQR, interquartile range; PK, pharmacokinetics.
NOTE: Children could only participate in each cohort for a single episode of malaria, and no episodes contributed data to both cohorts.
*Signifies that P value <.05 for comparison of parameter of interest between parasite clearance and intensive PK cohorts.
a96.6% of HIV-infected children were on daily trimethoprim-sulfamethoxazole prophylaxis.
bNote that children must have been ≥10 kg to be eligible for parasite clearance study enrollment, but could be ≥6 kg for intensive cohort enrollment.
cComparison parasite clearance slope half-lives of HIV-infected (n = 22) and HIV-uninfected children (n = 77), P = .003.
dn = 7 for parameter estimate.
eData from the intensive cohort has been previously published and is provided here to enable comparison between the demographics of the parasite clearance cohort.
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