Table 1.

Incidence of malaria by ART regimen overall and stratified by treatment arm and current CD4⁺ stratum.

	ART regimena	Events	Person years	Rateb	Rate ratiob	Rate ratiob,c
					P = 0.02d	P = 0.05b,d
	NNRTI containing	435	4737	9.3 (8.3–10.4)	1	1
	NRTI only	5	50	9.9 (3.6–27.4)	1.1 (0.4–3.0)	1.6 (0.6–4.3)
	PI containing	7	202	3.5 (1.6–7.6)	0.4 (0.2–0.8)	0.4 (0.2–1.0)
Stratified by treatment arm					P = 0.92e	P = 0.95e
					P = 0.62f	P = 0.64f
CTX	NNRTI containing	97	2380	4.1 (3.3–5.0)	1	1
	NRTI only	1	25	4.2 (0.5–32.1)	1.0 (0.1–8.0)	1.5 (0.2–11.8)
	PI containing	2	100	2.0 (0.5–8.2)	0.5 (0.1–2.0)	0.5 (0.1–2.3)
					P = 0.07f	P = 0.11f
Placebo	NNRTI containing	338	2357	14.5 (12.9–16.4)	1	1
	NRTI only	4	25	15.4 (4.9–48.0)	1.1 (0.3–3.3)	1.6 (0.5–5.0)
	PI containing	5	102	5.0 (2.0–12.4)	0.3 (0.1–0.9)	0.4 (0.2–1.0)
Stratified by current CD4+ cell count					P = 0.86e	P = 0.96e
					P = 0.21f	P = 0.30f
CD4+ <500	NNRTI containing	200	2358	8.6 (7.5–10.1)	1	1
	NRTI only	2	33	7.0 (1.5–32.0)	0.8 (0.2–3.7)	1.4 (0.3–6.1)
	PI containing	4	118	3.5 (1.2–9.6)	0.4 (0.1–1.1)	0.5 (0.2–1.3)
					P = 0.21f	P = 0.24f
CD4+ ≥500	NNRTI containing	235	2379	9.9 (8.6–11.5)	1	1
	NRTI only	3	17	13.9 (3.6–54.4)	1.4 (0.4–5.5)	1.8 (0.5–6.6)
	PI containing	3	84	3.5 (1.1–11.6)	0.4 (0.1–1.2)	0.4 (0.1–1.4)

ART, antiretroviral therapy; CTX, cotrimoxazole; NNRTI, non-nucleoside reverse transcriptase; NRTI, nucleoside reverse transcriptase; PI, protease inhibitor.

^aNNRTI containing was defined as a regimen that contained at least one NNRTI and no PI; NRTI only was defined as a regimen containing only NRTIs; PI containing was defined as a regimen in which at least one of the drugs was a PI.

^bestimated from random effects Poisson regression.

^cadjusted for treatment arm, site, and time since enrolment.

^dP value for effect of ART regimen, from likelihood ratio test (LRT).

^eLRT for interaction between treatment arm and ART regimen, and between treatment arm and CD4⁺ cell count group.

^fP value from the Wald test.