Management of HIV-associated tuberculosis in resource-limited settings: a state-of-the-art review

Table 6 Randomized controlled studies of the timing of starting antiretroviral therapy (ART) during tuberculosis (TB) treatment

Study	Study population				Methods		Results
	N	Location	TB	Median CD4+ cells/mm³(IQR)	Timing of ART in weeks ‘earlier’ vs ‘later’	Primary endpoint	Follow-up in months	Primary endpoint ‘earlier’ vs ‘later’^a	Primary endpoint in CD4 <50 cells/μl^b	TB immune reconstitution
SAPIT [48] (first analysis)	429	South Africa	Smear-positive pulmonary TB	150 (77 to 254)	<12 vs after end TB treatment	Death	12.1	5.4 vs 12.1 P = 0.003^c	Not reported	12.4% vs 3.8% P <0.001
SAPIT [96] (second analysis)	429	South Africa	Smear-positive pulmonary TB	150 (77 to 254)	Within 4 vs 8 to 12	AIDS or death	17.7	6.9 vs 7.8 P = 0.73	8.5 vs 26.3^b P = 0.06	20.1% vs 7.7% P <0.001
CAMELIA [95]	660	Cambodia	Smear-positive TB	25 (11 to 56)	2 vs 8	Death	25	18% vs 27%, P = 0.006	Not reported^d	33.1% vs 13.7% P <0.001
STRIDE [55]	809	Multicontinent^e	Confirmed or presumed pulmonary or extrapulmonary TB	77 (36 to 145)	2 vs 8 to 12	AIDS or death	12	12.9% vs 16.1% P = 0.45	15.5% vs 26.6% P = 0.02	11% vs 5% P = 0.02
TB Meningitis [97]	253	Vietnam	TB meningitis	39 (18 to 116)	≤1 vs 8	Death^f	12	59.8% vs 55.6% P = 0.50	63.3% vs 65.1% P = 0.84	Not reported
TIME Trial [98]	156	Thailand	Confirmed or presumed pulmonary or extrapulmonary TB	43 (37 to 106)	4 vs 12	Death	96 weeks	7.6% vs 6.5% P >0.99	8.7% vs 13.1% P = 0.725	8.86 vs 5.02 P = 0.069

Footnotes:
^aPresented either as cumulative incidence of primary endpoint in early vs. later arm (%) or as events per 100 person-years.
^bPrespecified analysis.
^cSignificant difference in mortality observed in patients with either CD4 counts <200 cells/μl or 200 to 500 cells/μl.
^dLower CD4 was not associated with an increased risk for the primary endpoint.
^eNorth America, South America, Asia, Africa.
^fPrimary endpoint was all cause mortality at 9 months.

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