Background
Aim
Methods
Study procedures
Laboratory methods
Statistical analysis
Results
Effect of CD4 on malaria
Clinical malaria | |||||
---|---|---|---|---|---|
Median value | Rate/100 person years (95 % CI)a
| Crude rate ratio (95 % CI)a
| Adjusted rate ratio (95 % CI)a,b
| Adjusted rate ratio (95 % CI)a,c
| |
CD4 count at infectiond
| P = 0.60 | P = 0.81 | P = 0.56 | ||
<300 | 262 | 14.6 (11.2–19.0) | 1 | 1 | 1 |
300–399 | 355 | 13.4 (11.0–16.3) | 0.9 (0.7–1.1) | 0.9 (0.7–1.2) | 0.9 (0.7–1.2) |
400–499 | 448 | 13.1 (11.1–15.5) | 0.9 (0.7–1.2) | 0.9 (0.7–1.2) | 0.9 (0.6–1.3) |
500–599 | 547 | 13.5 (11.5–15.9) | 0.9 (0.7–1.3) | 0.9 (0.6–1.3) | 0.9 (0.6–1.4) |
600–699 | 644 | 14.2 (11.7–17.1) | 1.0 (0.7–1.4) | 0.9 (0.6–1.5) | 1.0 (0.6–1.6) |
≥700 | 836 | 15.5 (12.7–19.0) | 1.1 (0.8–1.5) | 1.0 (0.6–1.7) | 1.2 (0.7–1.9) |
Baseline factors | |||||
Site | P < 0.001 | P < 0.001 | P = 0.002 | ||
Entebbe | 10.6 (8.8–12.8) | 1 | 1 | 1 | |
Masaka | 17.2 (14.9–19.9) | 1.6 (1.3–2.1) | 1.5 (1.2–1.9) | 1.5 (1.1–1.9) | |
Age (years)d
| P = 0.07 | P = 0.04 | P = 0.04 | ||
<35 | 31 | 12.4 (10.0–15.2) | 1 | 1 | 1 |
35–44 | 39 | 15.1 (12.8–17.9) | 1.2 (1.0–1.5) | 1.2 (1.0–1.5) | 1.2 (1.0–1.5) |
≥45 | 50 | 14.0 (11.5–17.1) | 1.1 (0.8–1.5) | 1.1 (0.8–1.4) | 1.1 (0.8–1.5) |
Sex | P = 0.83 | P = 0.46 | P = 0.63 | ||
Male | 14.4 (11.4–18.1) | 1 | 1 | 1 | |
Female | 13.9 (12.2–16.0) | 1.0 (0.7–1.3) | 0.9 (0.7–1.2) | 0.9 (0.7–1.2) | |
SES | P < 0.001 | P = 0.002 | P = 0.003 | ||
Low | 16.1 (13.6–19.0) | 1.8 (1.3–2.4) | 1.7 (1.3–2.4) | 1.7 (1.2–2.3) | |
Middle | 15.7 (12.8–19.1) | 1.7 (1.2–2.4) | 1.6 (1.1–2.2) | 1.6 (1.1–2.2) | |
High | 9.0 (6.9–11.8) | 1 | 1 | 1 | |
Baseline CD4 countd
| P = 0.63 | P = 0.88 | P = 0.98 | ||
<350 | 310 | 13.3 (10.4–16.9) | 1 | 1 | 1 |
350–499 | 422 | 13.1 (10.7–16.1) | 1.0 (0.7–1.3) | 1.0 (0.7–1.3) | 1.0 (0.7–1.4) |
≥500 | 634 | 14.7 (12.1–18.0) | 1.1 (0.8–1.5) | 1.0 (0.8–1.4) | 1.0 (0.6–1.5) |
Factors during follow-up | |||||
Time since enrolment (years) | P < 0.001 | P < 0.001 | |||
<1 | 17.3 (14.8–20.1) | 1.9 (1.4–2.6) | 1.9 (1.4–2.7) | ||
1–2 | 13.1 (10.8–15.7) | 1.4 (1.0–2.0) | 1.5 (1.0–2.1) | ||
≥2 | 9.0 (6.7–12.1) | 1 | 1 | ||
BMI (kg/m2) | P = 0.01 | P = 0.02 | |||
<18.5 | 10.0 (6.9–14.4) | 0.6 (0.4–0.9) | 0.6 (0.4–0.9) | ||
18–24.9 | 15.8 (13.8–18.1) | 1 | 1 | ||
≥25 | 11.6 (8.9–15.0) | 0.7 (0.5–1.0) | 0.8 (0.6–1.0) | ||
Bed net use | P = 0.05 | P = 0.14 | |||
≥90 % of visits | 13.2 (11.6–15.1) | 1 | 1 | ||
<90 % of visits | 17.5 (13.7–22.3) | 1.3 (1.0–1.7) | 1.2 (0.9–1.6) |
Effect of CD4 count on malaria by trial arm
Trial arm | Stratum | Episodes | Person years | Rate/100 person years (95 % CI)a
| Rate ratiob
| P valuec
|
---|---|---|---|---|---|---|
CD4 count at ART initiation | ||||||
CTX | <100 | 30 | 698 | 4.0 (2.8–5.9) | 1 | 0.99 |
100–249 | 59 | 1461 | 3.9 (3.0–5.1) | 1.0 (0.6–1.5) | ||
250+ | 10 | 229 | 3.9 (2.0–7.4) | 1.0 (0.5–2.0) | ||
Placebo | <100 | 92 | 709 | 12.4 (9.8–15.7) | 1 | 0.73 |
100–249 | 196 | 1458 | 13.4 (11.4–15.7) | 1.1 (0.8–1.4) | ||
250+ | 36 | 212 | 14.7 (10.1–21.5) | 1.2 (0.8–1.9) | ||
CD4 count at enrolment | ||||||
CTX | <350 | 14 | 416 | 3.5 (2.0–5.9) | 1 | 0.51 |
350–499 | 32 | 900 | 3.4 (2.4–4.8) | 1.0 (0.5–1.9) | ||
500+ | 57 | 1234 | 4.3 (3.3–5.7) | 1.3 (0.7–2.3) | ||
Placebo | <350 | 58 | 453 | 13.1 (9.8–17.5) | 1 | 0.98 |
350–499 | 117 | 850 | 13.6 (11.1–16.7) | 1.0 (0.7–1.5) | ||
500+ | 175 | 1211 | 13.4 (11.3–16.0) | 1.0 (0.7–1.4) | ||
CD4 count at infection | ||||||
CTX | <350 | 21 | 4618 | 4.4 (2.9–6.9) | 1 | 0.52 |
350–499 | 30 | 8811 | 3.3 (2.3–4.7) | 0.7 (0.4–1.3) | ||
500+ | 52 | 1197 | 4.0 (3.0–5.4) | 0.9 (0.5–1.5) | ||
Placebo | <350 | 60 | 390 | 14.6 (11.1–19.2) | 1 | 0.32 |
350–499 | 98 | 807 | 11.8 (9.5–14.6) | 0.8 (0.6–1.1) | ||
500+ | 192 | 1317 | 14.1 (12.0–16.5) | 1.0 (0.7–1.3) |